MINISTÉRIO DA EDUCAÇÃO UNIVERSIDADE FEDERAL DO RIO GRANDE DO NORTE CENTRO DE CIÊNCIAS DA SAÚDE PROGRAMA DE PÓS-GRADUAÇÃO EM CIÊNCIAS DA SAÚDE EFEITOS DA REABILITAÇÃO VESTIBULAR EM IDOSOS COM VERTIGEM POSICIONAL PAROXÍSTICA BENIGNA (VPPB): ENSAIO CLÍNICO CONTROLADO E RANDOMIZADO KARYNA MYRELLY OLIVEIRA BEZERRA DE FIGUEIREDO RIBEIRO NATAL – RN 2015 KARYNA MYRELLY OLIVEIRA BEZERRA DE FIGUEIREDO RIBEIRO EFEITOS DA REABILITAÇÃO VESTIBULAR EM IDOSOS COM VERTIGEM POSICIONAL PAROXÍSTICA BENIGNA (VPPB): ENSAIO CLÍNICO CONTROLADO E RANDOMIZADO Tese de doutorado apresentada ao Programa de Pós-Graduação em Ciências da Saúde da Universidade Federal do Rio Grande do Norte como requisito para obtenção de Doutor em Ciências da Saúde. Orientador: Prof. Dr. Ricardo Oliveira Guerra NATAL/RN 2015 MINISTÉRIO DA EDUCAÇÃO UNIVERSIDADE FEDERAL DO RIO GRANDE DO NORTE CENTRO DE CIÊNCIAS DA SAÚDE PROGRAMA DE PÓS-GRADUAÇÃO EM CIÊNCIAS DA SAÚDE Coordenador do Programa de Pós-Graduação em Ciências da Saúde: Prof. Dr. Eryvaldo Sócrates Tabosa do Egito iii KARYNA MYRELLY OLIVEIRA BEZERRA DE FIGUEIREDO RIBEIRO EFEITOS DA REABILITAÇÃO VESTIBULAR EM IDOSOS COM VERTIGEM POSICIONAL PAROXÍSTICA BENIGNA (VPPB): ENSAIO CLÍNICO CONTROLADO E RANDOMIZADO Aprovada em 22/06/2015 Banca Examinadora: Presidente da Banca: Prof. Dr. Ricardo Oliveira Guerra Membros da Banca: Prof. Dr. José Diniz Júnior Profa. Dra. Juliana Maria Gazzola Prof. Dr. André Luiz dos Santos Silva Profa. Dra. Flávia Doná Simone iv DEDICATÓRIA A minha tia/mãe Iara Barros Bezerra (in memorian). v AGRADECIMENTOS A Deus, pelo dom da vida, por dar-me a oportunidade da realização desse Doutorado e prover forças nos momentos de desânimo. Ao meu marido Arthur, companheiro em todos os momentos e exemplo de profissionalismo, dedicação e altruísmo. A minha filha Laura com o seu sorriso e a pureza nata da criança parecia entender os meus momentos de ausência. Vocês são a razão do meu viver e querer sempre me aprimorar em todos os sentidos. A minha mãe Mariza, pilar de honestidade e retidão de caráter, minhas irmãs e eternas companheiras Karyne e Karol e meus sogros Marineve e Ranice os quais me ajudam nos cuidados com minha filha o que tornou esse processo mais ameno. A minha tia Iara Bezerra (in memorian) a qual foi o meu alicerce para chegar até aqui. Ao meu querido orientador, Prof. Dr. Ricardo Oliveira Guerra, sempre me motivando e abrindo meus horizontes na pesquisa científica. Foi o meu principal incentivador a retomar os caminhos da Reabilitação Vestibular. À profa. Dra. Nandini Deshpande, minha orientadora canadense que sempre me encorajou ao propor desafios. Desde o início acreditou na minha pesquisa mesmo diante de todas as adversidades. À equipe do ambulatório de Otoneurologia da UFRN. Em especial a Dra. Luciana Fontes Cunha Lima a qual se interessou e viabilizou o início e seguimento desta pesquisa. À fonoaudióloga e amiga Djanine Andrade por todo apoio na condução do estudo. A Dra. Susan Whitney, exemplo de simplicidade e competência na área da Reabilitação Vestibular, por toda orientação no design do estudo e acolhimento em Pittsburgh. A Camila e Rafaela, que auxiliaram em todas as etapas da pesquisa. A Leonardo Medeiros, Bruna Steffani e Bruna Oliveira também sempre dispostos a auxiliar no que fosse necessário. E a minha querida pupila Raysa Freitas, hoje “braço direito” e colega de profissão sempre compromissada e competente no que faz. Aos companheiros do laboratório 07 vinculados ao Grupo de Epidemiologia do Envelhecimento e Fisioterapia Geriátrica: Ana Carolina Patrício, Dimitri, Aline Falcão, Juliana, Mayle, Saionara e Cristiano. À amiga e otorrinolaringologista Lidiane Maria Brito, minha grande parceira científica. Ao prof. Dr. e amigo Álvaro Campos, pelas orientações estatísticas. Ao prof. Dr. e amigo André Luis dos Santos Silva, pelos ensinamentos e por ter me apresentado a esta fascinante temática da Reabilitação Vestibular. vi Aos meus queridos colegas de trabalho do Hospital Regional Deoclécio Marques de Lucena, por toda a compreensão nesse processo e apoio em ajudar-me nos plantões para que eu alcançasse essa conquista. Aos professores membros da banca pelas contribuições a este trabalho. Aos idosos participantes da pesquisa, por serem, os pacientes, as pessoas, ao fim de tudo, a motivação do que quer que se faça na área científica. vii RESUMO Introdução: a Vertigem Posicional Paroxística Benigna (VPPB) é uma das principais causas de tontura em idosos. O tratamento mais empregado para essa afecção é a Manobra de Reposicionamento Canalítico (MRC). Apesar de útil na resolução clínica da sintomatologia vertiginosa e do nistagmo, os pacientes podem continuar demonstrando prejuízo na estabilidade postural após serem submetidos à MRC. Outra opção não farmacológica disponível são os exercícios de Reabilitação Vestibular (RV) que podem ser direcionados à melhora do equilíbrio postural dos idosos, porém há escassez de estudos que avaliem a efetividade da RV no equilíbrio postural de idosos com VPPB. Objetivo: analisar a efetividade da Terapia de Reabilitação Vestibular associada às Manobras de Reposicionamento Canalítico em comparação às Manobras de Reposicionamento Canalítico no tratamento de idosos com Vertigem Posicional Paroxística Benigna (VPPB) crônica. Métodos: participaram do presente ensaio clínico controlado, randomizado e cego 14 idosos de ambos os sexos e idade igual ou superior a 65 anos e com diagnóstico de VPPB crônica. Os idosos foram randomizados em dois grupos, sendo sete (mediana: 69 anos, 65-78) para o grupo experimental e sete (mediana: 73 anos, 65-76) para o grupo controle. Ambos os grupos foram submetidos a Manobras de Reposicionamento Canalítico (MRC) para VPPB e somente o grupo experimental à Terapia de Reabilitação Vestibular (TRV) associada às MRC. Os efeitos da TRV foram mensurados em relação à conversão do teste de Dix-Hallpike de positivo para negativo, recorrência da VPPB, número de manobras para obter a negativação do teste de Dix-Hallpike, sintomatologia da tontura, qualidade de vida e ao equilíbrio estático e dinâmico. Os idosos foram submetidos a uma avaliação inicial (T0), em uma semana (T1), cinco (T5), nove (T9) e treze semanas (T13). Em todas as avaliações o teste de Dix-Hallpike foi realizado com o auxílio do sistema de Videonistagmoscopia (SVNC) da Contronic - Brasil, e em caso positivo, nova MRC foi empregada. As diferenças entre os grupos foram analisadas pelos testes de Mann Whitney e exato de Fisher e para elucidar as diferenças intra-grupo os testes não paramétricos de Friedman e Wilcoxon foram usados. Resultados: nenhuma diferença significativa foi encontrada na conversão do teste de Dix-Hallpike de positivo para negativo, na recorrência da VPPB e no número de manobras para a negativação do teste de Dix-Hallpike, entre os grupos ao longo do ensaio. Também não foram encontradas diferenças entre os grupos na sintomatologia da tontura, qualidade de vida e equilíbrio estático. Contudo, diferenças significativas foram observadas nos aspectos do equilíbrio dinâmico entre os grupos (p ˂ viii 0,05). Na análise intra-grupo ambos os grupos obtiveram melhora em todas as medidas de desfecho, porém o grupo controle não obteve melhora no equilíbrio dinâmico. Conclusões: a TRV adicional não influenciou na conversão do teste de Dix-Hallpike de positivo para negativo, na recorrência da VPPB, no número de manobras para a negativação do teste de Dix-Hallpike, na redução da sintomatologia da tontura e na qualidade de vida dos idosos com VPPB crônica. Porém, os participantes que receberam a TRV adicional demonstraram melhores resultados no equilíbrio dinâmico do que aqueles que foram submetidos somente às MRC. Os resultados desse estudo deverão repercutir nas estratégias de reabilitação baseadas em evidências nos pacientes idosos com disfunções otoneurológicas. PALAVRAS-CHAVES Tontura, doenças vestibulares, idosos, reabilitação. ix LISTA DE ABREVIATURAS E SIGLAS FIBRA – Rede de Estudos sobre a Fragilidade em Idosos Brasileiros AVC – Acidente Vascular Cerebral VPPB – Vertigem Posicional Paroxística Benigna CSC – Canal (is) Semicircular (res) MRC – Manobra (s) de Reposicionamento Canalítico RV – Reabilitação Vestibular CONSORT – Consolidated Standards of Reporting Trials REBEC – Registro Brasileiro de Ensaios Clínicos CEP/HUOL – Comitê de Ética em Pesquisa do Hospital Universitário Onofre Lopes HUOL – Hospital Universitário Onofre Lopes GC – Grupo Controle GE – Grupo Experimental IMC – Índice de Massa Corporal ATC – Anatomical Therapeutic Chemical Classification System CID – 10 - Classificação Internacional de Doenças CG – Centro de Gravidade mCTSIB – Teste Clínico modificado de Interação Sensorial no Equilíbrio AU – Teste do Apoio Unipodal LE – Limite (s) de Estabilidade DGI – Dynamic Gait Index UFRN – Universidade Federal do Rio Grande do Norte EVA – Escala Visual Analógica DHI – Dizziness Handicap Inventory cm – centímetros SVNC – Sistema de Videonistagmoscopia infravermelha Computadorizada x LISTA DE ABREVIATURAS E SIGLAS TRV – Terapia de Reabilitação Vestibular VOR - Vestibular Oculomotor Reflex SPSS – Statistical Package for the Social Sciences SNC – Sistema Nervoso Central RN – Rio Grande do Norte PPGCSA – Programa de Pós-Graduação em Ciências da Saúde SUS – Sistema Único de Saúde PE – Pensilvânia EUA – Estados Unidos da América IL – Illinois OR – Oregon GEEFG – Grupo de Epidemiologia do Envelhecimento e Fisioterapia Geriátrica PPGFIS – Programa de Pós-Graduação em Fisioterapia CAPES - Coordenação de Aperfeiçoamento de Pessoal de Nível Superior xi LISTA DE FIGURAS Figura 1 – Ilustração das otocônias no utrículo e das otocônias deslocadas Figura 2 – Desenho esquemático da canalitíase e cupulolitíase Figura 3 – Teste Clínico modificado de Interação Sensorial no Equilíbrio (mCTSIB) Figura 4 – Teste da marcha em Tandem Figura 5 – Sistema de Videonistagmoscopia Infravermelha Computadorizada (SVNC) Figura 6 – Teste diagnóstico de Dix-Hallpike para VPPB Figura 7 – Execução da Manobra de Reposicionamento Canalítico de Epley Figura 8 – Ilustrações da Terapia de Reabilitação Vestibular (TRV) ARTIGO 1: Effectiveness of Otolith Repositioning Maneuvers and Vestibular Rehabilitation exercises in elderly people with Benign Paroxysmal Positional Vertigo (BPPV): a systematic review. Figure 1 – Fluxogram for the selection articles. ARTIGO 2: “Positive to Negative” Dix-Hallpike test and Benign Paroxysmal Positional Vertigo recurrence in elderly undergoing Canalith Repositioning Maneuver and Vestibular Rehabilitation. Figura 1 – Fluxogram of the study. Figura 2 – Descriptive analysis of the “positive to negative” Dix-Hallpike test at baseline (T0), first (T1), fifth (T5), ninth (T9) and thirteenth week (T13) of assessment. ARTIGO 3: Effects of Balance Vestibular Rehabilitation Therapy in elderly with Benign Paroxysmal Positional Vertigo (BPPV): a randomized controlled trial. Figure 1 – CONSORT (Consolidated Standards of Reporting Trials) flow diagram. xii LISTA DE TABELAS E QUADROS Quadro 1. ARTIGO 1: Effectiveness of Otolith Repositioning Maneuvers and Vestibular Rehabilitation exercises in elderly people with Benign Paroxysmal Positional Vertigo (BPPV): a systematic review. Table 1 – Synopsis of data from Randomized Controlled clinical trials about the effectiveness of Otolith Repositioning Maneuver (ORM) and Vestibular Rehabilitation (VR) exercises in the treatment of Benign Paroxysmal Positional Vertigo (BPPV) in elderly people. Table 2 – Methodological analysis by PEDro score of clinical trials about the effectiveness of Otolith Repositioning Maneuvers (ORM) and Vestibular Rehabilitation (RV) exercises in the treatment of BPPV in elderly people. ARTIGO 2: “Positive to Negative” Dix-Hallpike test and Benign Paroxysmal Positional Vertigo recurrence in elderly undergoing Canalith Repositioning Maneuver and Vestibular Rehabilitation. Chart 1 - Characteristics of the elderly with BPPV sample during 13 weeks. Table 1 - Number of maneuvers performed per session in experimental and control groups at baseline (T0), first (T1), fifth (T5), ninth (T9) and thirteenth (T13) week of assessment. ARTIGO 3: Effects of Balance Vestibular Rehabilitation Therapy in elderly with Benign Paroxysmal Positional Vertigo (BPPV): a randomized controlled trial. Table 1 – Baseline characteristics of participants Table 2 – Participants’ performance on standing and dynamic balance in between and within group comparisons for experimental and control groups at baseline, one week, five weeks, nine weeks and thirteen weeks. Table 3 – Participants’ performance on symptom (VAS) and quality of life (DHI) in between and within group comparisons for experimental and control groups at baseline, one week, five weeks, nine weeks and thirteen weeks. xiii SUMÁRIO 1. INTRODUÇÃO............................................................................................................. 15 Envelhecimento populacional e tonturas ...................................................................... 15 Tonturas de origem vestibular ...................................................................................... 15 Vertigem Posicional Paroxística Benigna (VPPB) ........................................................ 16 Limitações funcionais na Vertigem Posicional Paroxística Benigna em idosos ............ 18 Avaliação e tratamento da Vertigem Posicional Paroxística Benigna ........................... 19 Equilíbrio postural e Vertigem Posicional Paroxística Benigna em idosos ................... 20 Reabilitação Vestibular na Vertigem Posicional Paroxística Benigna ........................... 20 2. JUSTIFICATIVA........................................................................................................... 22 3. OBJETIVOS................................................................................................................. 23 4. MÉTODOS .................................................................................................................. 24 Desenho do estudo....................................................................................................... 24 Procedimentos éticos ................................................................................................... 24 Participantes ................................................................................................................. 24 Critérios de inclusão .................................................................................................. 24 Critérios de exclusão ................................................................................................. 24 Randomização e procedimentos de coleta ................................................................... 25 Medidas de desfecho.................................................................................................... 25 Desfechos primários .................................................................................................. 26 Desfechos secundários ............................................................................................. 29 Intervenções ................................................................................................................. 30 Análise Estatística ........................................................................................................ 36 5. ARTIGOS PRODUZIDOS ............................................................................................ 37 6. COMENTÁRIOS, CRÍTICAS E CONCLUSÕES .......................................................... 96 7. REFERÊNCIAS ......................................................................................................... 101 APENDICES .................................................................................................................. 106 ANEXOS ........................................................................................................................ 113 xiv 1. INTRODUÇÃO Envelhecimento populacional e tonturas As Nações Unidas (2013) (1) afirmaram que a proporção de idosos na população mundial irá aumentar de 11,7% em 2013 para 21.1% em 2050. Esta mudança na composição etária da população é decorrente, sobretudo, dos avanços da biotecnologia, da diminuição nas taxas de natalidade e do aumento da longevidade humana (2, 3). O envelhecimento populacional repercute no aumento da prevalência de doenças crônicas e incapacitantes e deve proporcionar uma mudança de paradigma, para que a saúde dos idosos seja vista sob a ótica da capacidade funcional e da autonomia do indivíduo (4). Além do acometimento de doenças específicas, os idosos sofrem com um número importante de síndromes, denominadas grandes síndromes geriátricas, tais como: incapacidade cognitiva, incontinência urinária, iatrogenia, instabilidade postural, imobilidade, incapacidade comunicativa e insuficiência familiar (5) A tontura é um sintoma que pode ser classificado como vertigem, desequilíbrio, pré-síncope e psicogênica (ou atípica) (6). No Brasil, estima-se que a tontura esteja presente em cerca de 45% da população de idosos (7), sendo considerada uma síndrome geriátrica multifatorial proveniente do efeito cumulativo de danos em múltiplos sistemas, que predispõe os idosos à vulnerabilidade em situações cotidianas (8, 9). Essa síndrome envolve diferentes causas, como problemas neurológicos, cardiovasculares, visuais, vestibulares e psicológicos, além dos problemas relacionados à polifarmacoterapia tão comum nos idosos (9, 10). Dados da Rede FIBRA (Rede de Estudos sobre a Fragilidade em Idosos Brasileiros) apontaram que os fatores associados de forma significativa à queixa de tontura foram: sexo feminino, depressão, dificuldade de memória, má percepção de saúde, comorbidades, fadiga, sonolência excessiva, medo de cair e pior desempenho em testes físico-funcionais do equilíbrio corporal. Sugere-se, assim, uma abordagem multifatorial da tontura em idosos, além de intervenções relacionadas à melhora da capacidade funcional e prevenção de quedas (7). Tonturas de origem vestibular Déficits no sistema vestibular são responsáveis por aproximadamente 85% das queixas de tontura (11). Podem ter origem periférica (acometendo o sistema vestibular 15 periférico, como a Vertigem Posicional Paroxística Benigna) ou central (encontradas em patologias do sistema nervoso central, como o AVC e a Doença de Parkinson) (12). As periféricas são as causas mais comuns de tontura na população idosa (10, 13, 14). O sistema vestibular é afetado pelo processo de envelhecimento, levando a uma tendência de aumento nas disfunções vestibulares (15). Além disso, o avanço da idade é diretamente proporcional ao surgimento e/ou aumento de diversos sintomas otoneurológicos associados, como vertigem e outras tonturas, perda auditiva, zumbido, déficit no equilíbrio postural, distúrbios na marcha e aumento do risco de quedas (16). Vertigem Posicional Paroxística Benigna (VPPB) Uma doença de origem vestibular tem chamado a atenção da comunidade científica: a Vertigem Posicional Paroxística Benigna (VPPB), a qual é a causa mais comum de vertigem em indivíduos de todas as faixas etárias e sexos, apresentando pico de prevalência por volta dos 60 anos (17) e incidência de 64/100.000 pessoas por ano (14). Estima-se que 25% dos idosos com mais de 70 anos com queixas de tontura tenham VPPB, e a maioria permanece com a queixa por mais de um ano (14). Acreditase que a prevalência ao longo da vida seja de 3,2% em mulheres, 1,6% nos homens e 2,4% na população geral (18). Apesar de sua alta prevalência, somente 10 a 20% dos pacientes que procuram ajuda médica recebem tratamento adequado da VPPB. Frequentemente, o tratamento é inalterado, com medicações supressoras do sistema vestibular (19). Um estudo epidemiológico na Alemanha demonstrou que apenas 8% dos portadores de VPPB recebem tratamento efetivo (16), enquanto outro realizado na Suécia determinou que a VPPB é subestimada pelos clínicos nos idosos com queixa de tontura que procuram a atenção primária (20). Estudos realizados em emergência clínica mostraram que dentre 3.522 atendimentos por queixa de tontura 156 pacientes relataram o diagnóstico de VPPB. No entanto, apenas 34 pacientes (21,8%) realizaram o teste diagnóstico clínico e seis pacientes (3,9%) receberem tratamento por meio de Manobras de Reposicionamento Canalítico (21). Apenas 11% dos médicos dos departamentos de emergência diagnosticam e tratam a VPPB por meio das manobras, sendo que 76% relatam que nunca aprenderam como realizá-las, 14% relataram não terem tempo de praticá-las e 10% acreditavam que deveriam tentar o tratamento primeiramente com medicações (22). 16 A VPPB é caracterizada pelo aparecimento de tontura rápida e de caráter rotatório em determinados movimentos da cabeça, como os realizados na hiperextensão cervical, inclinação ou rotação do corpo e quando o paciente levanta-se e/ou deita-se na cama. A vertigem e os demais sintomas associados são desencadeados pelo deslocamento de fragmentos de estatocônios (otocônias) provenientes da mácula do utrículo para um ou mais canais semicirculares, transformando-os em um órgão sensível à gravidade, que normalmente não o são (23, 24). Figura 1. Ilustração das otocônias no utrículo e das otocônias deslocadas. Fonte: http://www.dizziness-and-balance.com/disorders/bppv/bppv.html A canalitíase é a forma mais comum da VPPB, caracterizada pelo movimento livre das otocônias na endolinfa dos canais semicirculares anterior, lateral ou posterior (25, 26). Entretanto, essas otocônias podem estar presas na cúpula da ampola do canal semicircular (CSC), quando é denominada cupulolitíase. Figura 2. Desenho esquemático da canalitíase e cupulolitíase. Fonte: http://www.dizziness-and-balance.com/age/Dizziness%20in%20the%Elderly.htm 17 O CSC mais acometido é o posterior, representando cerca de 90% da população com VPPB (27, 28). Além disso, a prevalência da doença é maior no sexo feminino, principalmente entre 41 e 60 anos, quando as mudanças nos níveis hormonais levam a osteoporose e osteopenia (29, 30). Uma revisão realizada por Yu et al. (2014) concluiu que há uma associação entre a Osteoporose e a ocorrência VPPB, embora não se tenham estudos suficientes para afirmar o papel da Osteopenia nessa doença. Acreditase que há associação entre o avanço da idade e a alta prevalência da VPPB em idosos, provavelmente dado por mudanças morfológicas nas otocônias, com consequente aumento dos fragmentos otoconiais. Além disso, ocorrem alterações no metabolismo do cálcio e isquemias microvasculares características dos idosos (13). Dados recentes demonstram que há também associação entre determinadas comorbidades e sintomas com a VPPB, tais como: perda auditiva, problemas de tireóide, hipercolesterolemia e parestesias, quando comparados os pacientes com a população em geral pareada por idade e sexo. Além disso, pode haver relação entre a predisposição familiar e o surgimento da doença (31). O primeiro estudo observacional e multicêntrico com pacientes portadores de VPPB envolveu 1092 sujeitos de 11 departamentos diferentes de Otorrinolaringologia, Otoneurologia e Neurologia em países dos continentes Asiático, Europeu e SulAmericano (15). Constatou-se que a presença de duas ou mais doenças sistêmicas associadas (Hipertensão, Diabetes Melitus, Osteoartrose e/ou Osteoporose) aumenta o risco de recorrência de VPPB, sendo maior a chance com a presença de Osteoporose. Limitações funcionais na Vertigem Posicional Paroxística Benigna em idosos A sintomatologia vertiginosa faz com que os pacientes que sofrem de VPPB passem a restringir suas atividades a fim de evitar crises, levando a alterações posturais e diminuição da qualidade de vida desses indivíduos (14, 32). Tais restrições de movimento em conjunto com doenças associadas, efeito colateral de medicamentos e a alta prevalência de VPPB em idosos, geralmente resulta em uma perda funcional, podendo levá-los à incapacidade (33, 34). Batuecas-Caletrio et al. (2013) (35) afirmaram que geralmente a atividade física é significativamente menor em pacientes com VPPB, principalmente nos mais idosos, os quais usufruem de menos lazer diário, permanecendo a maior parte do tempo em casa. Um estudo transversal realizado com uma amostra de 491 idosos que viviam de forma 18 independente revelou associação entre sedentarismo e presença de VPPB em mulheres (36). Essa enfermidade também aumenta a incidência de quedas, assim como a chance de fraturas, traumas cranianos (concussão), hospitalizações e depressão. É aconselhável tratar a VPPB e suas múltiplas variações, para minimizar potenciais morbidades relacionadas às quedas. Além disso, o controle postural estático e dinâmico em pacientes idosos com vestibulopatias encontra-se prejudicado, o que contribui para uma limitação funcional e, consequentemente, maior insegurança quanto a quedas nessa população (7, 37-40). Idosos com VPPB apresentam piores escores em testes funcionais devido à coexistência de múltiplas morbidades, o medo de cair que caracteriza a população geriátrica e a senescência do sistema vestibular comumente presente nessa população, o que pode prejudicar ainda mais o equilíbrio postural desses indivíduos (35). Avaliação e tratamento da Vertigem Posicional Paroxística Benigna O teste de Dix-Hallpike é considerado padrão ouro para o diagnóstico de VPPB dos Canais Semicirculares (CSC) anterior e posterior, enquanto que o roll-test é utilizado para identificar a VPPB do CSC horizontal, devendo ser associada à história clínica do paciente (41). O paciente com VPPB pode apresentar o nistagmo de posicionamento com características próprias durante a realização do teste de Dix-Hallpike, sendo denominada de VPPB “objetiva”. Quando há ausência do nistagmo de posicionamento, a VPPB é denominada “subjetiva” (42-44). Após a identificação do canal semicircular afetado, o tratamento é feito por meio de manobra para reposicionamento dos otólitos, que são movidos para fora do canal afetado ou da cúpula e levada de volta ao utrículo (41). A escolha de qual manobra é mais adequada vai depender do CSC envolvido e do tipo de VPPB. A Manobra de Reposicionamento Canalítico (MRC), também conhecida como manobra de Epley é considerada o tratamento clínico mais comum para pacientes com VPPB de canal posterior, pois é considerada segura e eficaz para atingir a remissão dos sintomas vertiginosos (24, 45, 46). Epley (1992) (45) sugeriu que há deslocamento dos otólitos do canal posterior de volta ao vestíbulo durante a realização da manobra, reduzindo os estímulos que causam a vertigem na VPPB. Bhattacharrya et al (2008) (47) e Fife et al (2008) (48) descreveram a manobra de Epley como “Recomendação nível A” com base em vários estudos clínicos randomizados, onde foram encontrados efeitos 19 estatisticamente significativos a favor da manobra em relação aos grupos controle. Ensaios clínicos demonstram que em curto prazo a MRC promove resolução da vertigem e do nistagmo de posicionamento com um pequeno número de repetições (4952), bem como melhora na qualidade de vida dos pacientes submetidos ao tratamento quando comparados à avaliação inicial (53, 54). Porém, a resolução dos sintomas em longo prazo tem sido pouco estudada (55). Apesar da grande eficácia das MRC, a doença pode apresentar quadros de recorrência e persistência. No caso de recorrência da VPPB, a reaplicação das manobras é útil para abreviar a duração dos sintomas durante as crises vertiginosas (23). No entanto, na forma persistente, quando não há respostas ao tratamento por meio da MRC por pelo menos um ano (56), pode-se optar por outras formas terapêuticas, como exercícios de RV, medicamentos supressores vestibulares, destruição química do labirinto ou procedimentos cirúrgicos (23, 57). Equilíbrio postural e Vertigem Posicional Paroxística Benigna em idosos Estudos do controle postural e da capacidade funcional em idosos com VPPB, afirmam que esses parâmetros melhoram após o tratamento com MRC (14, 58, 59). Um estudo verificou melhora clínica na remissão da sintomatologia vertiginosa, nistagmo de posicionamento e redução no número de quedas em idosos após a realização das MRC, porém após 12 meses subsequentes às MRC a maioria deles (85,1%) continuou apresentando quedas (60). Os autores sugerem que ocorrem falhas em outros sistemas relacionados ao controle postural, devendo ser investigadas e tratadas. Lança et al. (2013) (58) mostraram que após 12 meses do tratamento, a posturografia estática apresentou anormalidades no equilíbrio estático similares àquelas encontradas antes do tratamento. Tendo em vista que a MRC não demonstra ser eficiente em longo prazo quanto à manutenção do equilíbrio postural, estudos recentes apontam a necessidade de exercícios de equilíbrio adicionais, como aqueles que enfatizam os estímulos vestibulares (14, 61). Reabilitação Vestibular na Vertigem Posicional Paroxística Benigna A Reabilitação Vestibular (RV) é indicada para disfunções unilateral e bilateral, periféricas e centrais, entretanto, é considerada segura e efetiva para disfunção vestibular unilateral periférica (62). Essa técnica é um recurso terapêutico para pacientes com distúrbios do equilíbrio postural e a proposta de atuação é baseada nos 20 mecanismos relacionados à plasticidade neural do Sistema Nervoso Central (SNC). O tratamento tem como objetivos: promover a estabilização visual e melhorar a interação vestíbulo-visual durante os movimentos da cabeça e ampliar a estabilidade postural estática e dinâmica nas condições que produzem informações sensoriais conflitantes e diminuir a sensibilidade individual à movimentação cefálica. Há evidências que a RV promove resolução dos sintomas e melhora na função em médio prazo (62-64), sendo um método de tratamento otoneurológico com grande aceitação na literatura, pois seus resultados favoráveis têm sido evidenciados em inúmeras pesquisas (62, 65-67). O programa de RV inclui exercícios de adaptação, habituação e substituição vestibulares associados a um conjunto de medidas relacionadas à mudança de hábitos e esclarecimentos sobre os sintomas associados à alteração do equilíbrio (63, 64). Apesar das MRC serem mais eficazes em curto prazo que os exercícios baseados na RV, a combinação das duas terapêuticas é mais eficaz na recuperação funcional em longo prazo (62). Angeli et al. (2003) (68) e Dorigueto et al. (2009) (23) propuseram o tratamento de RV adicional naqueles pacientes que apresentaram persistência dos sintomas da VPPB com as MRC. Angeli et al. (2003) (68) realizaram RV nos pacientes que não apresentaram remissão dos sintomas após 1 mês de tratamento por meio da manobra (grupo experimental) ou de forma espontânea (grupo controle), observando melhora na vertigem e no nistagmo após 1 mês o início da RV. Dorigueto et al. (2009) (23) realizaram um estudo longitudinal propondo um protocolo de reabilitação aquática para pacientes com VPPB na forma persistente, encontrando que após o acompanhamento clínico por um ano de 100 pacientes, a VPPB não foi recorrente em 70% dos pacientes (taxa de cura), recorrente em 26% e persistente em 4% deles. Uma recente revisão sistemática (69) encontrou apenas dois estudos associando RV e MRC. Chang et al. (2008) (61) realizaram MRC tanto no grupo experimental quanto no grupo controle, enquanto o grupo experimental foi também submetido à RV adicional para o equilíbrio. Tanimoto et al. (2005) (70) também realizaram MRC em ambos os grupos, mas o grupo experimental foi orientado a realizar auto-manobra em domicílio (considerado como exercício de habituação pelos autores da revisão) 3 vezes por dia até alcançar a resolução dos sintomas de vertigem posicional por 24 horas. Ambos os estudos encontraram resultados satisfatórios na remissão dos sintomas, sendo encontrados por Chang et al. (2008) (61) bons resultados também em relação ao equilíbrio postural. 21 2. JUSTIFICATIVA A VPPB é na maioria das vezes tratada por períodos muito curtos com Manobras de Reposição Canalítica (MRC), pois existe forte evidência científica que são a principal terapia no tratamento da VPPB, promovendo melhora da vertigem e do nistagmo (28, 47, 48, 71). Alguns autores demonstraram que o controle postural e a capacidade funcional em pacientes com VPBB melhoram após o tratamento com as MRC (14, 58, 59), já outros afirmam que esses não conseguem retomar sua estabilidade postural normal após as MRC, apoiando a associação do tratamento com exercícios de RV (61, 68, 72). O risco de quedas é significativamente maior em idosos com VPPB associada, então é aconselhável lidar com a doença e suas múltiplas variações para minimizar morbidades relacionadas a esse evento que pode ser potencialmente evitado. Apesar de a TRV ser considerada uma ferramenta terapêutica coadjuvante no tratamento da VPPB até a presente data, nenhum ensaio clínico controlado e randomizado foi encontrado para avaliar os efeitos dos exercícios de Reabilitação Vestibular associados às Manobras de Reposicionamento Canalítico nos parâmetros clínicos e/ou funcionais em idosos com VPPB, justificando-se a realização deste trabalho. 22 3. OBJETIVOS Objetivo geral Avaliar prospectivamente a efetividade da Terapia de Reabilitação Vestibular associada às Manobras de Reposicionamento Canalítico em comparação às Manobras de Reposicionamento Canalítico no equilíbrio postural estático e dinâmico de idosos com Vertigem Posicional Paroxística Benigna (VPPB) crônica. Objetivos específicos 1. Caracterizar os idosos quanto à idade, sexo, lado acometido e sintomas vestibulares da VPPB; 2. Descrever as doenças associadas e os medicamentos utilizados pelos idosos portadores de VPPB crônica; 3. Verificar a conversão do teste de Dix-Hallpike de positivo para negativo, a recorrência da VPPB e o número de manobras para obter a negativação do teste de Dix-Hallpike em idosos com VPPB crônica submetidos à Terapia de Reabilitação Vestibular associada às Manobras de Reposicionamento Canalítico; 4. Analisar os resultados obtidos entre os idosos portadores de VPPB crônica submetidos à Terapia de Reabilitação Vestibular associada às Manobras de Reposicionamento Canalítico. 23 4. MÉTODOS Desenho do estudo Ensaio clínico randomizado, controlado, uni-cego, com dois braços. Procedimentos éticos A pesquisa seguiu as recomendações estabelecidas pelo CONSORT (Consolidated Standards of Reporting Trials), 2010 (73), encontra-se registrada no REBEC (Registro Brasileiro de Ensaios Clínicos) com o número: RBR-7jkbyg e foi aprovada no Comitê de Ética em Pesquisa do Hospital Universitário Onofre Lopes (CEP/HUOL), sob o protocolo 543/11 de acordo com a resolução 196/96. Participantes Idosos com diagnóstico de Vertigem Posicional Paroxística Benigna (VPPB) crônica (por no mínimo seis meses) foram encaminhados do ambulatório de Otoneurologia do Hospital Universitário Onofre Lopes (HUOL) e de outros serviços públicos ou privados das especialidades médicas que tratassem pacientes com queixas de tontura na cidade do Natal/RN. Critérios de inclusão Foram incluídos no estudo indivíduos com idade igual ou superior a 65 anos, de ambos os sexos, que apresentassem teste de Dix-Hallpike positivo com vertigem acompanhada ou não de nistagmo de posicionamento. Critérios de exclusão Foram excluídos da amostra pacientes que apresentassem riscos de lesão na coluna cervical para a execução tanto do teste diagnóstico de Dix-Hallpike quanto para a Manobra de Reposicionamento Canalítico, tais como: sintomas neurológicos cervicais, amplitude de movimento cervical muito limitada e/ou com instabilidade (a manobras envolve movimentos de torção e extensão cervical); pacientes com outras doenças neurológicas (por. ex. problemas somatosensoriais graves, acidente vascular cerebral, 24 doença de Parkinson), problemas ortopédicos (por. ex. osteoartrite grave de joelho ou deformidades acentuadas em membros inferiores) e/ou doenças sistêmicas (tais como, hipertensão, diabetes mellitus e disfunções na tireoide) sem controle medicamentoso (por serem possíveis fatores de confusão que afetariam o equilíbrio postural); pacientes sem capacidade de entender e responder a comandos verbais simples; pacientes previamente tratados com MRC e/ou protocolos de exercícios para treinamento do equilíbrio postural e que estivessem realizando alguma atividade física do tipo: fortalecimento muscular, pilates, yoga ou exercícios aeróbios de alta intensidade. Os idosos que apresentaram alguma intercorrência grave de saúde impedindo a continuidade do tratamento ou que não quisessem dar continuidade à terapêutica instituída também foram excluídos da pesquisa. Os participantes foram informados sobre os procedimentos e objetivos da pesquisa e para aqueles que aceitaram participar do estudo foi solicitada a assinatura de um Termo de Consentimento Livre e Esclarecido. Randomização e procedimentos de coleta Após a triagem para definição dos critérios de inclusão e exclusão o processo de randomização foi realizado em blocos com a sequência gerada por um programa de computador (www.randomization.com). O processo de randomização e alocação foi realizado por um pesquisador independente não envolvido no ensaio clínico. Os pacientes, então, foram distribuídos aleatoriamente em dois grupos: 1 - Grupo controle (GC) – Manobra de Reposicionamento Canalítico (MRC) (ou de Epley modificada); e 2 Grupo experimental (GE) - Manobra de Reposicionamento Canalítico (MRC) (ou de Epley modificada) associada à Terapia de Reabilitação Vestibular (TRV). As avaliações e as MRC foram executadas por pesquisadores cegos, diferentes dos que realizaram o tratamento de Reabilitação Vestibular. Os participantes foram avaliados no início (T0), em uma (T1), cinco (T5), nove (T9) e treze semanas (T13). Houve anuência do médico assistente para a suspensão das preparações antivertiginosas uma semana antes do início do estudo. Medidas de desfecho Um questionário clínico multidimensional foi utilizado para coletar os dados sociodemográficos (idade, sexo, raça, nível de escolaridade e ocupação) e 25 antropométricos (Índice de Massa Corporal em kg/m2); anamnese dirigida para a VPPB, com questões sobre a natureza (primária ou secundária) e o tipo da tontura (vertigem, flutuação, espontânea ou pré-síncope), sintomas neurovegetativos associados, tempo do início da tontura, duração, periodicidade, se desencadeada pelo movimento corporal ou de forma espontânea, presença de nistagmo, lado acometido (direito, esquerdo ou bilateral), número de manobras de MRC realizadas, presença de zumbido; dados sobre saúde, incluindo comorbidades e uso de medicamentos; além da realização de exercício físico, lado dominante e uso de dispositivo auxiliar para a marcha. A classificação do uso de medicamentos foi realizada utilizando-se a Anatomical Therapeutic Chemical Classification System (ATC), um sistema de códigos alfanuméricos desenvolvido pela OMS para a classificação de medicamentos e outros produtos médicos. A classificação foi de acordo com o 2º nível (74). Com relação às doenças associadas, o sistema de classificação foi a Classificação Internacional de Doenças (CID – 10). Essa é a classificação diagnóstica padrão internacional para propósitos epidemiológicos e administrativos da saúde, incluindo análise da situação geral de grupos populacionais e monitoramento da incidência e prevalência de doenças e outros problemas de saúde (75). Desfechos primários As medidas de desfecho primário estiveram relacionadas ao equilíbrio estático e dinâmico dos pacientes. Essas foram: a média da velocidade de oscilação do Centro de Gravidade (CG) em graus por segundo no Teste Clínico modificado de Interação Sensorial no Equilíbrio (mCTSIB) e a média da velocidade de oscilação do CG no teste do Apoio Unipodal (AU) também em graus por segundo. A média da velocidade do movimento do CG (em graus por segundo) e a excursão máxima (em porcentagem do Limite de Estabilidade), a velocidade da marcha (em centímetros por segundo) e a média da velocidade de oscilação final do CG no teste da caminhada em Tandem (graus por segundo). O equilíbrio em tarefas dinâmicas foi avaliado pela versão brasileira do Dynamic Gait Index (DGI). A avaliação objetiva do equilíbrio estático e dinâmico foi realizada por meio do equipamento Balance Master System da NeuroCom® International, Inc do Laboratório de Fisioterapia Geriátrica e Epidemiologia Clínica do Departamento de Fisioterapia da Universidade Federal do Rio Grande do Norte (UFRN). O instrumento possui duas 26 plataformas de força adjacentes conectadas a um computador, o qual é capaz de detectar as oscilações no Centro de Gravidade (CG) dentro de um limite de estabilidade (LE) predefinido. O sistema provê medidas quantitativas do desempenho do equilíbrio estático e dinâmico e feedback visual da excursão e posição do CG. Os pacientes permaneciam em pé sobre as duas plataformas de força enquanto observavam uma tela (76). Para maior segurança durante as avaliações, dois avaliadores mantiveram-se de cada lado do paciente no caso desse último perder o equilíbrio. O equilíbrio estático foi mensurado pelo Teste Clínico modificado de Interação Sensorial no Equilíbrio (mCTSIB) e pelo teste do Apoio Unipodal (AU). O mCTSIB examina a oscilação postural em 4 condições sensoriais: em pé na superfície firme com os olhos abertos e fechados e em pé na almofada com os olhos abertos e fechados. No teste AU os participantes foram avaliados sobre o membro dominante com os olhos abertos e fechados. Cada teste consistiu de três provas com duração de 10 segundos. Figura 3. Teste Clínico modificado de Interação Sensorial no Equilíbrio (mCTSIB) Balance Master System da NeuroCom® International, Inc Fonte: arquivo pessoal O equilíbrio dinâmico foi aferido pela velocidade de movimento do CG e sua excursão máxima no teste do LE; velocidade da marcha no teste da caminhada e a velocidade de oscilação final no teste da caminhada em Tandem. No teste do LE, o alvo representa a distância teórica máxima que o indivíduo é capaz de deslocar o seu CG sem perder o equilíbrio ou mudar a posição dos pés. A velocidade do movimento no teste do LE é representada pela média da velocidade de deslocamento do CG durante os 8 segundos do teste e a excursão máxima do LE é representada pela maior distância alcançada durante a prova. No teste da velocidade da 27 marcha, os participantes foram instruídos a executá-lo em sua marcha casual e sua progressão foi quantificada, não tendo sido considerado a marcação durante a zona de aceleração e desaceleração ambas fora da plataforma de força. No teste da caminhada em Tandem os sujeitos foram instruídos a caminharem encostando o calcanhar de um pé nos artelhos do outro de forma constante, caminhar o mais rápido possível e parar ao final da plataforma de força (desaceleração). Foi registrado o componente anterior/posterior da velocidade de oscilação do CG por 5 segundos iniciando quando o paciente terminava de caminhar. Ambos os testes consistiram de três provas com duração de 10 segundos cada. Figura 4. Teste da marcha em Tandem - Balance Master System da NeuroCom® International, Inc Fonte: arquivo pessoal O Dynamic Gait Index (DGI) é um instrumento de avaliação funcional constituído por oito tarefas que envolvem a marcha e o equilíbrio no qual o paciente modifica a marcha em resposta às mudanças nas exigências de determinadas tarefas comuns do dia-a-dia, como mudanças na velocidade da marcha, movimentos horizontais e verticais da cabeça durante essa atividade, girar sobre o próprio eixo corporal, contornar e passar por cima de obstáculos e subir e descer escadas (77). Trata-se de uma escala ordinal com quatro alternativas variando de 0 (comprometimento grave) a 3 pontos (normal), com definições de pontuações de acordo com o desempenho em cada tarefa e ponto de corte ˂ 19 pontos indicando risco de quedas (78). Um aumento da pontuação total de ≥ 4 pontos identifica melhora clínica com o tratamento (79). 28 Desfechos secundários As medidas de desfecho secundárias foram: a intensidade da tontura e a qualidade de vida aferidas pela Escala Visual Analógica (EVA) e a versão brasileira do Dizziness Handicap Inventory (DHI), respectivamente, a conversão do teste de DixHallpike de positivo para negativo, a recorrência da VPPB e o número de MRC para obter a negativação do teste de Dix-Hallpike. A avaliação da recorrência foi feita levando-se em consideração a negativação do teste de Dix-Hallpike com positivação posterior no período de avaliação das 13 semanas. A Escala Visual Analógica da tontura (EVA) tem a finalidade de medir a intensidade dos sintomas como a tontura e o desequilíbrio. Os pacientes classificaram a intensidade da tontura por meio de uma EVA de 10 cm com a variação dos sintomas entre nenhum sintoma (0 cm) e 10 (10 cm), o pior sintoma possível (80). O DHI é um questionário de auto-relato o qual avalia a influência da tontura e da instabilidade na qualidade de vida de pacientes com desordens vestibulares (81). O questionário é composto por 25 itens que aferem o aspecto físico, o aspecto emocional e o aspecto funcional. Os aspectos físicos do DHI brasileiro avaliam a relação entre o aparecimento e/ou piora do sintoma tontura aos movimentos dos olhos, da cabeça e do corpo. O aparecimento de tontura em determinadas posições ou movimentos da cabeça e/ou do corpo é comum em pacientes com VPPB. Os aspectos emocionais investigam a possibilidade da tontura prejudicar a qualidade de vida, gerando frustração, medo de sair desacompanhado ou ficar em casa sozinho, vergonha de suas manifestações clínicas, preocupação quanto à autoimagem, distúrbio de concentração, sensação de incapacidade, alteração no relacionamento familiar ou social e depressão. Os aspectos funcionais investigam a interferência da tontura na realização de determinados movimentos dos olhos, da cabeça e do corpo, porém com enfoque na capacidade em desempenhar as atividades profissionais, domésticas, sociais, de lazer, e na independência ao se realizar tarefas como caminhar sem ajuda e andar pela casa no escuro. As pontuações variam a partir de 0 (nenhuma deficiência) a 100 pontos (deficiência grave). Cada resposta “sim” do paciente corresponde a 4 pontos, “às vezes”, 2 pontos, e a resposta “não”, nenhum ponto. A pontuação do DHI é o resultado do somatório da pontuação das respostas referentes aos aspectos físico, emocional e funcional (81). Após o tratamento, uma redução ≥ 18 pontos no questionário é considerada como uma melhora significativa na qualidade de vida. (79). Na amostra 29 estudada havia dois pacientes analfabetos no grupo experimental (2/7) e outros dois (2/7) no grupo controle, diante disso os autores adaptaram o questionário pela exclusão do item 07 (“devido à sua tontura, você tem dificuldade para ler?”), o qual está relacionado com os aspectos funcionais. Intervenções Para a confirmação do diagnóstico da VPPB os idosos foram submetidos ao teste de Dix-Hallpike com o auxílio de um Sistema de Videonistagmoscopia Infravermelha Computadorizada (SVNC, Contronic, Brasil). O SVNC é um sistema computadorizado que utiliza o princípio da captação dos movimentos oculares por meio de sensores infravermelhos colocados em óculos especiais ou máscara. O programa do computador demonstra, cronometra e grava os movimentos oculares que podem ser visualizados em um monitor de vídeo (Figura 01). O SVNC é útil na avaliação do nistagmo posicional e de posicionamento (latência, duração e direção), em particular no diagnóstico da VPPB. O nistagmo à prova de Dix-Hallpike pode ser de pequena amplitude, de duração fugaz e nem sempre é identificado ou caracterizado à simples observação visual. O controle ao SVNC é útil no diagnóstico e no registro dos movimentos oculares durante as manobras terapêuticas da VPPB. O SVNC é uma prova de interesse diagnóstico funcional e diferencial e de controle evolutivo de afecções de etiologias variadas (82). Figura 5. Sistema de Videonistagmoscopia Infravermelha Computadorizada (SVNC) Contronic, Brasil. Fonte: arquivo pessoal O teste foi realizado em ambos os lados, sempre pelo menos avaliador e horário, iniciando-se por aquele que o paciente referisse menor intensidade dos sintomas. Quando o paciente não soube relatar qual a posição responsável pelo aparecimento da vertigem, a manobra foi iniciada pelo lado direito. Desta forma, era identificado qual o lado que deveria ser tratado pela MRC modificada de Epley. O teste consistiu nas 30 seguintes fases: primeiramente, o paciente sentou-se com as pernas estendidas na mesa de exame com a cabeça rodada a 45º para o lado a ser testado. O examinador segurou a cabeça do paciente auxiliando-o a adotar rapidamente o decúbito dorsal com a cabeça pendente para fora da mesa e em extensão cervical de aproximadamente 30º (41, 83). Observou-se o movimento ocular por 1 minuto em busca de nistagmo e questionou-se o paciente a presença de vertigem. O paciente foi então ajudado a voltar à posição sentada com a cabeça ainda rodada e o nistagmo novamente foi observado. O mesmo procedimento foi repetido com a cabeça girada para o outro lado. Para confirmação do acometimento do canal semicircular posterior o nistagmo deveria durar menos de 1 minuto e ser do tipo torsional superior, nos casos de canalitíase e 1 minuto ou pouco mais para a cupulolitíase (24, 68, 84). Os pacientes foram classificados de acordo com o substrato fisiopatológico e o canal semicircular envolvido, indicados pelas características do nistagmo e movimento desencadeante, como descrito por Herdman e Tusa (2007) (85). Foram excluídos do estudo os casos de tontura com nistagmos atípicos, ou seja, com características diferentes das descritas por Herdman à manobra diagnóstica. Foram aceitos os casos onde durante o teste a vertigem estivesse presente associada ou não ao nistagmo de posicionamento. Lopez-Escamez et al., 2000 (86), relataram uma sensibilidade de 82% e especificidade de 71% no teste de Dix-Hallpike para a VPPB de canal posterior. O teste apresenta também um valor preditivo positivo de 83% e preditivo negativo de 52% para o diagnóstico da VPPB de canal posterior e anterior (87). Figura 06. Teste diagnóstico de Dix Hallpike para VPPB. Fonte: http://www.dizziness-and-balance.com/treatment/images/dix-hallpike-c.jpg A MRC foi conduzida de acordo com a descrição de Epley (1992), porém nenhum dos pacientes recebeu pré-medicação antes do tratamento ou usou vibração no osso 31 mastoide (45, 55). Teve-se a seguinte descrição para manobra de Epley: o paciente iniciou sentado, com as pernas estendidas na mesa de exame e com a cabeça rodada a 45º para o lado acometido. Em seguida o paciente era movimentado para assumir a posição do teste de Dix-Hallpike. A cabeça do paciente foi, então, rodada 90º (45º a partir do lado acometido para 45º em direção ao lado são). Este passo foi seguido pela rotação do tronco do paciente em direção ao lado são (ele era instruído a adotar o decúbito lateral sobre o ombro e olhar para o chão) mantendo a cabeça em rotação. Ao final, o paciente foi cuidadosamente conduzido à posição sentada, completando a manobra (41, 83) (Figura 06). Cada posição esteve mantida de 30 a 60 segundos ou até enquanto durasse o nistagmo e/ou a vertigem (24). Figura 07. Execução da Manobra de Reposicionamento Canalítico de Epley. Fonte: http://www.dizziness-and-balance.com/images/epley-cd.jpg De acordo com protocolo instituído em estudos prévios (24, 68, 88), a MRC foi realizada até 3 vezes em uma mesma sessão caso os sinais e sintomas persistissem no reteste (repetição do teste de Dix-Hallpike após a manobra de Epley) (89). No trabalho de Oliveira et al., 2015 (90) o reteste apresentou sensibilidade de 51.8% e uma alta especificidade de 91.89% com valor preditivo positivo de 82.35% e negativo de 72.34%. Assim, os autores recomendam que nos casos de reteste positivo, uma nova manobra de reposicionamento poderá ser realizada na mesma consulta. 32 Antes de cada manobra era explicado aos pacientes que o tratamento poderia causar vertigem e náusea, ou até mesmo que eles poderiam ter a sensação de estar “caindo”, porém eram encorajados a continuarem a se submeterem a manobra, pois os sintomas deveriam ser passageiros. Eles também foram solicitados a relaxar os músculos cervicais para evitar lesão na região. Após a MRC os idosos foram orientados a evitar movimentos de rotação e flexo-extensão extremos da cabeça, evitar deitar para o lado afetado por 48 horas, e orientados que elevassem a cabeceira da cama ao dormir nas 24 horas seguintes (55). As manobras de reposição canalítica foram executadas por fisioterapeutas treinados. As avaliações e o tratamento dos pacientes foram realizados no Departamento de Fisioterapia da UFRN. Após uma semana (T1), os idosos realizaram o mesmo protocolo de avaliação inicial, e aqueles que apresentaram o teste de Dix-Hallpike positivo foram submetidos à MRC novamente, além do protocolo de Reabilitação Vestibular para os idosos pertencentes ao Grupo Experimental (GE). O mesmo ocorreu com cinco semanas (T5), nove semanas (T9) e treze semanas (T13) após a avaliação inicial totalizando cinco avaliações. Os sujeitos do GE realizaram exercícios de RV personalizados, o que foi convencionado nesta pesquisa por Terapia de Reabilitação Vestibular (TRV), com frequência semanal de duas vezes por semana por um período de doze semanas (91) supervisionado por um fisioterapeuta treinado e um assistente. Os atendimentos tiveram duração média de 50 minutos. Os principais déficits e limitações funcionais foram identificados na avaliação inicial e os exercícios prescritos foram endereçados para os problemas específicos do idoso. Com programas de exercícios personalizados, o terapeuta avalia o progresso do paciente regularmente e promove feedback ao paciente quanto à forma adequada para a realização dos exercícios. Acredita-se que esse tipo de procedimento aumenta a adesão do paciente ao tratamento (92) A TRV incluiu exercícios de adaptação (VORx1) e habituação vestibulares (movimentos de cabeça e tronco repetidos), treino de equilíbrio estático e dinâmico e exercícios de fortalecimento muscular secundário dos membros inferiores (sentar e levantar, elevação na ponta dos pés e abdução e adução de quadril na posição ortostática) (61, 93). Os seguintes materiais foram utilizados: almofada Balance Pad da marca AIREX, Bola suíça de 65 ou 75cm, cones (20cm), bolas de plástico, caneleiras (0,5 a 1 kg), garrafa plástica (25 cm) e alvos de papel. O programa de exercícios objetivou estimular o sistema vestibular e promover a recalibração sensorial. Quando a função somatossensorial, visual e/ou vestibular está reduzida ou perdida, o sistema 33 nervoso central sofre reajuste a fim de tornar as modalidades restantes mais dependentes. Portanto, durante a TRV o paciente é repetidamente exposto a informações sensoriais para que o cérebro possa aperfeiçoar as respostas para a manutenção do equilíbrio (63). Para cada exercício prescrito uma série contendo 10 modificadores e padrões de progressão universal foram seguidos visando tornar os exercícios mais desafiadores (93) (Quadro 01). Postura na qual o exercício é executado; b) tipo de superfície de suporte; c) tamanho da base de suporte; (d) posicionamento do tronco; (e) posicionamento dos braços; (f) direção dos planos de movimento da cabeça; (g) direção do movimento corporal; (h) modificação visual; (i) presença ou ausência de dupla tarefa; (j) distância do alvo para a execução dos exercícios de RVO (figura 07). Cada exercício era mantido até 40 segundos e foram repetidos duas a três vezes em cada membro ou posicionamento. Modificadores Características dos exercícios Postura Sentado, em pé e deambulando Superfície Nivelada, espuma, com obstáculos (contornar ou transpor), escadas e rampas Pés separados, pés juntos, semi-tandem e Base de apoio Tandem Posição do tronco Ereto, inclinado, rodado Posição dos braços Ao lado do corpo, Afastado do corpo, cruzados no tórax, alcançando à frente Direção dos movimentos da cabeça Ereta, Yaw, Pitch, Row Direção do movimento corporal Antero-posterior, latero-lateral, multidirecional Entradas visuais Olhos abertos e olhos fechados Dupla tarefa cognitiva Sim ou Não Circunstâncias especiais Se o VORx1 foi executado com o alvo visual próximo (40 cm) ou afastado do corpo (80 cm) Quadro 1. Modificadores e respectivas características dos exercícios utilizados na Terapia de Reabilitação Vestibular. Fonte: Adaptado de Alsalaheen et al., 2012 (93) 34 Figura 07. Ilustrações da Terapia de Reabilitação Vestibular (TRV). Fonte: Visual Health Information, WA, USA Durante a TRV os terapeutas conduziram os exercícios para garantir movimentação cefálica e corporal adequadas visando potencializar os resultados (seguindo os preceitos da habituação), monitoravam posturas inadequadas, além de promoverem maior segurança ao paciente (61, 93). Os participantes foram orientados a relatar quaisquer queixas durante ou após a realização dos exercícios (tontura, náusea ou dor, por exemplo), os quais poderiam ser um motivo para modifica-los durante a terapia, e a não iniciar qualquer atividade física diferente durante o estudo. Eles também foram encorajados a realizar os exercícios em domicílio descritos em uma cartilha uma vez ao dia. A cartilha era atualizada a cada semana de acordo com a progressão do paciente. 35 Análise Estatística A normalidade dos dados foi avaliada pelo teste de Shapiro-Wilk. As diferenças entre os grupos na avaliação inicial relacionadas à distribuição do sexo, presença de nistagmo, nível de atividade física e o lado dominante foram analisadas pelo teste exato de Fisher, e as diferenças em relação à idade, IMC, tempo do início da tontura, número de comorbidades e medicações pelo teste de Mann Whitney. As diferenças entre os grupos quanto às medidas de desfecho numéricas obtidas nas avaliações de início (T0), em uma (T1), cinco (T5), nove (T9) e treze (T13) semanas foram analisadas por meio do teste de Mann-Whitney. Para as variáveis dicotômicas, o teste exato de Fisher foi empregado (Dix-Hallpike positivo ou negativo e a taxa de recorrência). Para elucidar as diferenças nas avaliações repetidas intragrupo ao longo do tempo, o teste não paramétrico de Friedman foi utilizado, e o teste de Wilcoxon para comparar a melhora intragrupo. O valor de r para o teste não paramétrico de Mann-Whitney foi realizado para avaliar o tamanho do efeito das intervenções. Os dados foram analisados utilizando-se a versão 20.0 do SPSS (Statistical Package for Social Sciences) com um nível de significância estatística estabelecido em p˂ 0,05. 36 5. ARTIGOS PRODUZIDOS Os resultados e discussão desta tese estão apresentados a partir dos seguintes artigos produzidos: ARTIGO 1. Effectiveness of Otolith Repositioning Maneuvers and Vestibular Rehabilitation exercises in elderly people with Benign Paroxysmal Positional Vertigo (BPPV): a systematic review. Submetido ao periódico European Archives of Oto-Rhino-Laryngology. ARTIGO 2. “Positive to Negative” Dix-Hallpike test and Benign Paroxysmal Positional Vertigo recurrence in elderly undergoing Canalith Repositioning Maneuver and Vestibular Rehabilitation. Aceito no periódico International Archives of Otorhinolaryngology. ARTIGO 3. Effects of Balance Vestibular Rehabilitation Therapy in elderly with Benign Paroxysmal Positional Vertigo: a randomized controlled trial. Submetido ao periódico Disability & Rehabilitation. 37 ARTIGO 1 Effectiveness of Otolith Repositioning Maneuvers and Vestibular Rehabilitation exercises in elderly people with Benign Paroxysmal Positional Vertigo (BPPV): a systematic review Karyna MOBF Ribeiro1,2, Nandini Deshpande3, Bruna S Oliveira2, Raysa VM Freitas2 and Ricardo O Guerra1,4 1 Post-Graduation Program in Health Sciences, Federal University of Rio Grande do Norte, Brazil. 2 Department of Physical Therapy, Federal University of Rio Grande do Norte, Brazil. 3 Faculty of Health Sciences, School of Rehabilitation Therapy, Queen's University, Canada. 4 Post-Graduation Program of Physical Therapy, Federal University of Rio Grande do Norte, Brazil. Corresponding author: Karyna Ribeiro, Department of Physical Therapy, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Senador Salgado Filho Avenue, 3000, Brazil. Email: [email protected] Objective: to evaluate the outcomes obtained by clinical trials on the effectiveness of Otolith Repositioning Maneuver (ORM) and Vestibular Rehabilitation (VR) exercises in the treatment of BPPV in elderly. Methods: the literature research was performed using PubMed, Scopus, Web of Science, PEDro and EBSCO databases, and included randomized controlled clinical trials in English, Spanish and Portuguese, published during January 2000 to August 2014. The methodological quality of the studies was assessed by PEDro score and the outcomes analysis was done by critical revision of content. Results: nine studies were fully reviewed. The average age of participants ranged between 60.6 to 75 years. Two articles were not assessed by PEDro score and the remaining received low classification varying from 2/10 to 6/10. The main outcome measures analyzed were vertigo, dizziness and nystagmus. Additionally, one study assessed the number of maneuvers necessary for remission of the symptoms and quality of life, and one evaluated functionality. The majority of the clinical trials used ORM (n=8), only 2 articles performed VR exercises in addition to ORM and pharmacotherapy, respectively. Four studies showed that the addition of movement restrictions after maneuver did not influence the outcomes. Conclusion: there was a trend of improvement to BPPV symptomatology in elderly patients who underwent ORM. There is sparse evidence from methodologically robust clinical trials that examined the effects of ORM and VR exercises for treating BPPV in the elderly. Randomized controlled clinical trials with comprehensive assessment of symptoms, quality of life, function and long-term follow up are warranted. Keywords: Benign paroxysmal positional vertigo, elderly, vertigo, dizziness, rehabilitation. Conflict of interest: the authors declare that there is no conflict of interest. Funding: this research received no specific grant from any funding agency. 38 BACKGROUND Dizziness is one of the most common symptoms in elderly people and it is considered a geriatric syndrome [1]. Among the causes of dizziness, Benign Paroxysmal Positional Vertigo (BPPV) is the most frequent vestibular disorder, affecting approximately 20% of patients presenting this symptom. BPPV is highly prevalent in elderly, probably due to senile degenerative changes [2,3]. Diagnosis of BPPV is confirmed using Dix-Hallpike test, and it is classified as objective when nystagmus is observed during the test, or subjective when there is vertigo without nystagmus [4]. Female patients have been shown to be most affected by BPPV, which may be justified by the fact that the homeostasis of labyrinthine fluids may be compromised by female hormones decreasing from climacteric phase [5]. Prevalence of BPPV is estimated at 25% in elderly people over 70 years with complaints about dizziness and this symptom persists for more than one year [6-8]. BPPV is directly proportional to multiple associated neurotological symptoms, such as vertigo, hearing loss, tinnitus, poor balance, gait disturbance, and an increase in risk of falls [9]. Patients with BPPV restrict their activities in order to avoid crises due vertiginous symptomatology, leading to postural changes and quality of life decreasing [8,10]. Such movement restrictions associated to comorbidities and high prevalence of BPPV in elderly usually result in functional loss and inability [11,12]. BPPV also increases incidence of falls in older patients, as well as chance of fracture, head traumas (concussion), hospitalizations and depression [13]. Elderly with BPPV show worse scores in functional tests due to coexistence of multiple morbidities, fear of falling that characterizes geriatric population and the senescence of vestibular system usually found in this population, which may further damage postural balance in these individuals [13,14]. Furthermore, static and dynamic postural control in elderly patients with vestibulopathies is damaged, which may contribute to a functional limitation and greater low balance confidence regarding falls in this population [3,1518]. Vertigo and other associated symptoms are triggered by the displacement of statocone (otocone) fragments from the utricle macula. The statocone freely float in the endolymph of one or more semicircular canals which become sensitive to changes in head position [19]. For these reasons, BPPV is mainly treated by Otolith Repositioning 39 Maneuvers (ORM) in order to move the otoconia out of the canal and lead it back to the vestibule. Other non-pharmacological intervention types include vestibular adaptation, habituation and substitution exercises, and patient education [20-22]. Although the use of ORM and Vestibular Rehabilitation (VR) exercises on treating BPPV are commonly proposed in the literature, it was observed that the majority of studies include a huge age variation in their experimental designs and intervention forms. Therefore, the present review aimed to evaluate the outcomes from randomized controlled clinical trials about the effectiveness of Otolith Repositioning Maneuvers and Vestibular Rehabilitation exercises in the treatment of Benign Paroxysmal Positional Vertigo in elderly people. METHODOLOGY For the present systematic review, the scientific question was established using PICO strategy (P-Patient, I-Intervention, C-Comparison, O-Outcomes) [23]. The component C-Comparison was excluded from the study because there is no comparison between interventions. Bibliographic research was performed during August, 2014 concomitantly in PubMed, Scopus, Web of Science, PEDro and EBSCO databases. It was limited to Portuguese, English and Spanish language papers which were published from January, 2000 to August, 2014. The strategy used was the combination of descriptors and key-words "benign paroxysmal positional vertigo" AND "physical therapy modalities" OR "rehabilitation" OR "exercise therapy" AND "vertigo" OR "dizziness" OR "postural balance." The filters used were “Clinical Trial” AND “Middle Aged + Aged: 45 + years” due to the average age adopted in this study being 60 years and over. After this process, only two key-words were combined ("Benign paroxysmal positional vertigo" AND "therapy"; “Benign Paroxysmal Vertigo” AND “Exercises”; “Benign Paroxysmal Positional Vertigo” AND “Treatment”; “Benign Paroxysmal Positional Vertigo” AND “Physical Therapy”). Then, duplicate articles among the databases were excluded. The following inclusion criteria were applied: 1) Participants with an average age of 60 years and over; 2) patients with BPPV and; 3) interventions by VR exercises and⁄or ORM. The studies were excluded if they were not randomized controlled trials (RCT), qualitative studies, studies with pharmacological or surgical interventions without association to VR exercises and/or ORM. 40 The construction of this systematic review was guided by the criteria of the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA statement) [24]. The methodological quality of selected RCT was assessed by PEDro score, which is comprised of 11 criteria about the internal validity and interpretation of clinical trials [25]. The score attributes 1 point for each criteria presented by the study. However, the first criterion (eligibility criterion) is not counted. Therefore, the closer the score is to 10 obtained by the study, the better is its methodological quality and data reproducibility. Each article score is given by trained specialists and it is available in PEDro database [26]. The studies selected for a full review were analyzed by two independent researchers and the disagreements between them were solved in consensus with assistance of a third evaluator who analyzed the divergent questions. RESULTS The research performed by the health descriptors and keywords resulted in 995 articles, but 29 studies were duplicates. Out of these, 832 studies were excluded after using the following filters: “clinical trials” and “middle aged + aged.” One hundred and thirtyfour abstracts were scrutinized. By reading the abstracts, it was found that 16 were published before 2000, 51 had average ages lower than 60 years or didn’t show the average age in full text, 43 were not clinical trials, 7 did not include BPPV as a sample characteristic, 7 were available in Italian, Chinese, German or Turkish languages and one study used only surgical treatment without associating with VR (Figure 1). Thereby, 9 RCT passed the criteria required for this review and were selected for critical analysis of their content. The synopsis of main data from the reviewed articles is displayed in Table 1. Table 2 shows that PEDro score ranged from 2 to 6 and two studies were not assessed by PEDro. Among the nine selected studies, the sample number varied from 16 to 342 patients, totaling 972 participants. The average age varied from 60.6 to 75 years. Two articles [27,28] used Semont Liberatory Maneuver (SLM) as the intervention, while one performed Semont-Toupet maneuver [29]. Six studies used Epley maneuver [29-34], four articles implemented movement restrictions after the ORM [29,31,32,34] and one study used a cervical collar and mini-vibrator applied on the mastoid of the affected side [34]. Two studies applied VR exercises [30,35], one study adopted in-home treatment 41 [33], two articles applied pharmacotherapy [27,35] and one study performed placebo maneuver [28]. Table 1 provides details about the intervention strategies used in each study. Three variables primarily analyzed in the selected studies included: vertigo [27,29,30,32,33], positional and/or liberatory nystagmus [28-33] and dizziness [29,31]. One study assessed the number of necessary maneuvers for remission of symptoms and the Dizziness Handicap Inventory (DHI) score [34], and two articles analyzed functionality by the Vestibular Disorders Activities of Daily Living scale (VDADL) [27,35]. Records identified in the databases (n=995) Records after duplicates removed (n=966) Articles excluded after filters using (CLINICAL TRIAL AND MIDDLE AGED+AGED) (n=832) Records screened (n=134) 125 excluded articles: • Articles pubished before 2000 (n= 16) • Average age lower than 60 years or not provided by the authors (n= 51) • Other study types (n= 43) • Treatment without VR association (n= 1) • Other languages studies (7) • Studies that did not aim to treat BPPV (7) Studies included in the qualitative analyses (n=9) Figure 01. Fluxogram for the selection of articles. 42 Table 1. Synopsis of data from randomized controlled clinical trials about the effectiveness of Otolith Repositioning Maneuvers (ORM) and Vestibular Rehabilitation (VR) exercises in the treatment of Benign Paroxysmal Positional Vertigo (BPPV) in elderly people. Author Year Country Sample Age (meanmedian) in years Type of study Outcome measures Intervention Results Angeli et al. 2003 EG: 28 CG: 19 EG: 74.5±4.5 CG: 74.2 ±3.4 Randomized controlled clinical trial 1) Vertigo: - Reported during Dix-Hallpike test 1st Phase - EG: ORM (Epley maneuver); - CG: no intervention. 1st Phase - 64% of patients from EG obtained negative DixHallpike test (no vertigo or nystagmus) compared to only 5% in CG (p<0.001). There was no difference in cure rate between the CG subgroup and the experimental group after maneuver performance (p=0.553). UNITED STATES (PEDRO: 4⁄10) Number of maneuvers: 1 to 3. Follow-up: 1 month. PC-BPPV 2) Positional nystagmus: Electronystagmography during Dix-Hallpike test. 2nd Phase - CG: Participants in CG who did not achieve spontaneous remission of symptoms received ORM (after 1 month). - The participants from both groups who did not get remission of symptoms, underwent a supervised VR exercises program. 2nd Phase - 18 patients received personalized VR. Seven patients had total remission of symptoms and⁄or nystagmus (negative Dix-Hallpike), 6 continued to present a positive test and 5 did not conclude the study. - At the end, 77% of patients obtained success in treatment. VR frequency: 2 or 3 times a week. Follow-up: 4 to 6 weeks. EG: experimental group; CG: control group; G1: group 01; G2: group 02 G3: group 03; DHI: Dizziness Handicap Inventory; VAS: Visual Analogic Scale; VDADL: Vestibular Disorders Activities of Daily Living scale; PC-BPPV: Benign Paroxysmal Positional Vertigo of Posterior Canal; VR: Vestibular Rehabilitation, ST: Semont-Toupet maneuver; SLM: Semont Liberatory Maneuver. 43 Table 1. Synopsis of data from randomized controlled clinical trials about the effectiveness of Otolith Repositioning Maneuvers (ORM) and Vestibular Rehabilitation (VR) exercises in the treatment of Benign Paroxysmal Positional Vertigo (BPPV) in elderly people. Author Year Country Sample Age (meanmedian) Type of study Outcome measures Intervention Results Resende et al. 2003 EG: 8 CG: 8 EG: 70.5 (61 – 82) CG: 69.3 (60 – 78) Randomized controlled clinical trial 1) Functionality (VDADL) GE: Cawthorne and Cooksey exercises protocol and pharmacotherapy (GingkoBiloba – 40mg de 12/12h); VR frequency: 2 sessions a week, during 5 weeks. - Significant decrease in VDADL scores in EG (p<0.01); CG: Pharmacotherapy. - Significant benefit to EG compared to CG (p<0.009). Brazil (PEDRO: 4⁄10) Do not specify the canal - There were no differences in the final score of VDADL in CG compared to pre-treatment phase; Follow-up: 5 weeks (EG) and 30 days (CG). Salvinelli et al. 2004 United Kingdom G1: 52 G2: 52 G3: 52 PC-BPPV G1: 73 (70 – 78) G2: 74.5 (71 – 80) G3: 75 (72 – 79) Randomized controlled clinical trial 1) Vertigo: - Reported during Dix-Hallpike test - G1: ORM (SLM). Number of maneuvers: 1 to 3 consecutive maneuvers per week until symptom resolution. 1) Functionality (VDADL) - G2: Calcium antagonists (10mg/d of Flunarizine before sleeping for 60 days); - G3: no treatment. Follow-up: 6 months after the end of each treatment. - G1: 94.2% of vertigo remission after 3 maneuvers and 3.8% of recurrence in 6 months; - G2: 57.7% of symptoms remission; 5.8% of recurrence in 6 months; - G3: 34.6% had spontaneous remission of symptoms; 21.1% of recurrence in 6 months; - A statistically significant post-treatment improvement in activities of daily living and in quality of life was noticed in G1 (p<0.001). EG: experimental group; CG: control group; G1: group 01; G2: group 02 G3: group 03; DHI: Dizziness Handicap Inventory; VAS: Visual Analogic Scale; VDADL: Vestibular Disorders Activities of Daily Living scale; PC-BPPV: Benign Paroxysmal Positional Vertigo of Posterior Canal; VR: Vestibular Rehabilitation, ST: Semont-Toupet maneuver; SLM: Semont Liberatory Maneuver. 44 Table 1. Synopsis of data from randomized controlled clinical trials about the effectiveness of Otolith Repositioning Maneuvers (ORM) and Vestibular Rehabilitation (VR) exercises in the treatment of Benign Paroxysmal Positional Vertigo (BPPV) in elderly people. Author Year Country Simoceli et al. 2005 Brazil Sample EG: 23 CG: 27 VPPB of posterior canal Roberts et al. 2005 EG: 21 CG: 21 PC-BPPV USA (PEDRO: 5⁄10) Age (meanmedian) 60.9 ± 15.3 Authors did not provide the median age by group EG: 67.9 (30 – 88) CG: 64.5 (40 – 83) Type of study Outcome measures Intervention Results Prospective randomized controlled clinical trial 1) Dizziness: - Reported during Dix-Hallpike test; - EG: ORM (Epley maneuver) + postural restriction instructions after maneuver - The follow-up demonstrated that 70% from both groups became asymptomatic after ORM; - CG: ORM (Epley maneuver) 2) Positional nystagmus: - Observed during Dix-Hallpike test. Prospective randomized controlled clinical trial 1) Vertigo: -Measured by VAS: - Reported in DixHallpike test and during three positions of Epley manuever; 2) Positional nystagmus (latency onset, duration, and intensity rating): - Observed by videoculography in Dix-Hallpike test during three positions of Epley maneuver. - No difference was observed in clinical outcomes in the group that received instructions about postural restrictions. Number of maneuvers: 2 consecutive. Follow-up: 72 ± 24 hours after Epley maneuver. EG: ORM (Epley maneuver) in association with neck brace and instructions about postural restrictions after maneuver. - The latency in starting time of nystagmus decreased from the first to the second positions of ORM in both groups, but no further decrease was observed; CG: ORM (Epley maneuver) only. - The nystagmus duration decreased from the first to the second positions of ORM in both groups but no further decrease was observed; - If symptoms persisted, the maneuver was repeated and the participant, regardless of group, was provided with post-maneuver restrictions and checked again after one week. Number of maneuvers: one maneuver. Follow-up: 1 week. - The position 1 provoked more dizziness according to VAS in both groups; - Results indicated there was no significant difference between the groups in terms of treatment outcome. 45 Table 1. Synopsis of data from randomized controlled clinical trials about the effectiveness of Otolith Repositioning Maneuvers (ORM) and Vestibular Rehabilitation (VR) exercises in the treatment of Benign Paroxysmal Positional Vertigo (BPPV) in elderly people. Author Year Country Sample Age (meanmedian) Type of study Outcome measures Intervention Results Tanimoto et al. 2005 EG: 40 CG: 39 64 years (24-85) Randomized controlled clinical trial - EG: ORM (Epley maneuver) + Selftreatment (self-maneuver). - Negative Dix-Hallpike test in 72% Epley-alone group and 90% from self-treatment group in 1 week (p=0.048); PC-BPPV Authors did not provide the median age by group 1 ) Vertigo: - Reported during Dix-Hallpike test; Japan (PEDRO: 3⁄10) 2) Positional nystagmus: - Observed by infrared CCD camera. - CG: ORM (Epley maneuver alone); Number of maneuvers - One maneuver performed in both groups. - Self-maneuver: 3 times a day until the patients achieved relief of positional vertigo for 24 hours. - Positional vertigo was completely resolved in 77% of patients from Epley-alone group and 88% from self-treatment group. No difference was found in between groups (p=0.22); - Resolution rate of both vertigo and nystagmus: 69% in Epley-alone group and 88% in selftreatment group (p=0.048). Follow up: 1 week André et al. 2010 G1: 23 G2: 15 G3: 15 Brazil PC-BPPV (PEDRO: 2⁄10) Ductolithia sis 67.2 (60 – 91) Authors did not provide the median age by group Randomized controlled clinical trial 1) Dix-Hallpike test; 2) Clinical aspects and symptoms: referred by Brazilian DHI questionnaire. - G1: ORM (Epley maneuver) + neck brace + Postural restrictions for 48 hours after maneuver; - G2: ORM (Epley maneuver); - G3: ORM (Epley maneuver) + Mini vibrator - Number of maneuvers ranged from 1 to 3 in all groups. No difference was found between groups; - Statistically significant difference was observed in all aspects evaluated by DHI after treatment in all groups; Number of maneuvers: one per session until complete remission of vertigo. - Significant improvement on physical aspects of G1 after treatment when compared to G2 (p=0.009); Follow up: time between evaluations was not informed. - Independent of the procedure after maneuver the ORM was effective based on DHI score. 46 Table 1. Synopsis of data from randomized controlled clinical trials about the effectiveness of Otolith Repositioning Maneuvers (ORM) and Vestibular Rehabilitation (VR) exercises in the treatment of Benign Paroxysmal Positional Vertigo (BPPV) in elderly people. Age (meanmedian) in years Author Year Country Sample Mandalà et al. 2011 EG: 174 CG: 168 EG: 62.1 ± 15.1 Italy PC-BPPV CG: 63.9 ± 16.2 (PEDRO: 6⁄10) Type of study Randomized controlled clinical trial Outcome measures 1) Positional and liberatory nystagmus: Electronystagmography or videoculography during DixHallpike test. Intervention Results - GE: ORM (SLM); - GC: Placebo Maneuver (non-affected side). - At the 1 h follow-up, 79.3% of patients who underwent SLM had recovered; - Patients in both groups were evaluated at the end of the first maneuver to check liberatory nystagmus; and at 1 hour and 24 hours of the maneuver to check positional nystagmus after SLM or sham maneuver performance. - Those that showed typical PC-BPPV at the 24 h follow-up were treated by SLM for the affected side. - 24h after SLM, 86.8% of subjects were free of BPPV, whereas none of the patients who underwent the sham maneuver recovered. No statistically significant differences were observed between the 1 and 24 h follow-ups in the SLM group; - Patients who presented liberatory nystagmus after SLM for the affected side showed significantly higher percentage of recovery at 1h follow-up (87.1 vs. 55.7%; p<0.0001). - Patients who still manifested PC-BPPV up to 2 weeks were treated again by SLM Number of maneuvers: one per session. Follow-up: 1 hour, 24 hours and 2 weeks Toupet at el. 2012 G1: 113 France PC-BPPV (PEDRO: 4⁄10) G1: 66 ± 1.3 G2: 113 G2: 63 ± 1.3 Prospective randomized controlled clinical trial 1) Dizziness and Vertigo: - Measured by VAS (0 to 5th day). 2) Vertigo: 1st Phase - G1: ORM (Epley maneuver); - G2: ORM (ST maneuver); - VAS for vertigo and dizziness decreased from day 0 to day 5 and demonstrated to be similar between Epley and ST groups; - In absence of liberatory signs after the maneuver, the maneuver was repeated twice. - The ST group showed higher rate of liberatory signs compared to Epley group (70% versus 51%; p<0.001). ST as a 3rd alternate maneuver yielded 47 - Observed after maneuver (liberatory sign). 3) Nystagmus: - Observed after maneuver (liberatory sign). - In absence of liberatory signs after 2 maneuvers the alternate maneuver was performed and the sequence was stopped. a higher rate of liberatory signs than Epley (12%, versus 3%, p< 0.02), however VAS for vertigo and dizziness did not seem to be influenced by these signs; 2nd Phase 2nd Randomization - G3: Postural restrictions maneuver; - G4: No postural restrictions; - Dizziness scores seemed to be influenced by the number of therapeutic maneuvers, and patients with 2 or 3 maneuvers scored their dizziness higher than those who had only one. The outcomes suggest that the number of maneuvers does not influence on vertigo intensity and has an unfavorable effect on perception of dizziness during 5 days follow up; after Number of maneuvers: up 2 until alternative maneuver with 7 min intervals between each maneuver. One maneuver at the alternative maneuver phase. Follow up: 5 days - It seems that postural restrictions after maneuver do not influence VAS scores for vertigo and dizziness. An effect of post-maneuver postural restriction was not found by analyzing the influence of VAS scores and liberatory signs in Epley and ST groups separately. EG: experimental group; CG: control group; G1: group 01; G2: group 02 G3: group 03; DHI: Dizziness Handicap Inventory; VAS: Visual Analogic Scale; VDADL: Vestibular Disorders Activities of Daily Living scale; PC-BPPV: Benign Paroxysmal Positional Vertigo of Posterior Canal; VR: Vestibular Rehabilitation, ST: Semont-Toupet maneuver; SLM: Semont Liberatory Maneuver 48 Table 2. Methodological analysis by PEDro score of clinical trials about the effectiveness of Otolith Repositioning Maneuvers (ORM) and Vestibular Rehabilitation (VR) exercises in the treatement of Benign Paroxysmal Positional Vertigo (BPPV) in elderly people. Angeli et al. 2003 Resende et al. 2003 Salvinelli et al.* 2004 Simoceli et al.* 2005 Roberts et al. 2005 Tanimoto et al. 2005 André et al. 2010 Mandala et al. 2011 Toupet at el. 2012 1 - Inclusion YES YES __ __ YES NO YES YES NO 2 – Random allocation YES YES __ __ YES YES YES YES YES 3 – Occultation in randomization NO NO __ __ NO NO NO NO NO 4 – Initial similarities among groups YES YES __ __ YES NO NO NO NO 5 – Masking participants NO NO __ __ NO NO NO YES NO 6 – Masking Therapists NO NO __ __ NO NO NO NO NO 7 – Masking Evaluators NO NO __ __ NO NO NO YES NO 8 – Outcome measures in 85% of the sample YES NO __ __ YES NO NO YES YES 9 – Intention to treat analysis NO NO __ __ NO NO NO NO NO 10 – Comparison between groups YES YES __ __ YES YES YES YES YES 11 – Central tendency NO YES __ __ YES YES NO YES YES Score 4⁄10 4⁄10 __ __ 5⁄10 3⁄10 2⁄10 6⁄10 4⁄10 49 DISCUSSION BPPV is the most common cause of vestibular vertigo and one of the otoneurological conditions that has the highest prevalence in the geriatric population, leading to strong impact on the health and quality of life of these individuals [36]. Non-pharmacological alternatives for its treatment, including the MRO, represent an important therapeutic opportunity as a result of absence of side effects risks commonly seen in older people. The increment of older population around the world will require special attention government health services. Comorbidities related to the aging process underlined by the deficit in physiological, cognitive and social functions, contribute to the development of diseases in multiple biological systems. The World Health Organization (WHO) [37] consider elderly people aged 65 years or older for developed countries, while in developing countries from 60 years old due to the rates of life expectancy in these countries. For this study we accepted this last criterion to expand the coverage of studies on BPPV in elderly people. We found very few trials with good methodological standard. Among the studies evaluated by PEDro score, the highest classification was 6⁄10. These findings warrant the need to conduct randomized controlled and blinded clinical trials in elderly people with BPPV, with robust methodology. In the majority of studies, patients presented BPPV of posterior canal [27-34], which according to literature is the most prevalent diagnosis [18,38,39]. Only one study did not specify the affected canal [35]. As for the ORM intervention in elderly, most studies applied the modified Epley maneuver [29-31,33,34]. Roberts et al. (2005) [32] used modified Epley maneuver with a variation at the end of sitting position (30º of cervical flexion). Only the study of André et al. (2010) [34] added a mini-vibrator on the mastoid process of the affected side. No study used the classic Epley maneuver. All the studies that used modified Epley maneuver described improvements in BPPV symptomatology, mainly for nystagmus, vertigo and dizziness. These findings agree with current literature, which places the Epley maneuver first in the treatment of BPPV of posterior canal. Fife et al. (2008) [40] classified the Epley maneuver for otolith repositioning as “Recommendation level A.” In other words, the therapy is effective and safe and must be offered to patients with BPPV of posterior canal of all ages. Studies analyzed samples with a predominance of middle aged BPPV patients and concluded that the Epley maneuver also had a positive impact on quality of life in physical, functional and emotional domains [41,42]. 50 The literature indicates Semont Liberatory Maneuver (SLM) as the treatment for cupulolithiasis of anterior and posterior canals [26,38]. Two articles mentioned having performed it. However, these studies performed SLM without clarifying if patients had cupulolithiasis or canalithiasis [27,28], with the exception being André et al. (2010) [34]. They clarified their sample as BPPV of posterior canal with ductolithiasis (canalithiasis). In the study conducted by Salvinelli et al. (2004) [27], the group that underwent SLM demonstrated a significantly superior percentage of symptom remission compared to the one that used only pharmacological intervention with Flunarizine (10mg/d before sleeping during 60 days). Furthermore, symptom recurrence rate was also lower in the maneuver group after six months. Only one article performed Semont-Toupet maneuver, which showed higher rate of liberatory signs (clinical improvement) after maneuver compared to Epley group [29]. Mandalà et al. (2011) [28] studied the effect of placebo maneuver group (which was performed on the non-affected side) compared to SLM. This last group obtained vertigo remission percentage of 79.3% and 86.8% after 1 hour and 24 hours, respectively. Von Brevern et al. (2006) [43] also performed a comparison of placebo maneuver and Epley maneuver and observed that 80% of patients in experimental group did not show vertigo or nystagmus during the positional test after 24h of treatment, compared to only 10% in control group. These findings suggest that both Epley maneuver and SLM are more effective than a placebo one. One of the studies used instructions and training for in-home maneuver performance three times a day until symptom remission for 24 consecutive hours in addition to the Epley maneuver [33]. Their results demonstrated that in-home maneuvers in addition to intervention practice resulted in significantly better outcomes in relation to vertigo, nystagmus and negative Dix-Halpike test. These findings are in line with previous studies that obtained 70% of negative tests in the group that only underwent the Epley maneuver [44-46], and 95% in the group that added self-treatment [47]. Overall, the findings suggest that Epley maneuver with additional instruction and training for in-home maneuver performance could be more effective when compared to Epley maneuver alone. The effect of movement restrictions after ORM has been a target intervention of research, given that several included studies assessed the efficacy of this practice after implementing the maneuver [29,31,32,34]. Two studies composed by one group that only underwent modified Epley maneuver and another one that included instructions for movement restrictions in addition to the maneuver [31,32]. After intervention, no significant difference was found between the two groups in either study. André et al. (2010) [34] also used a neck brace in one group, in addition to movement restriction instructions. This study concluded that independent of procedures performed 51 after Epley maneuver, it was effective in improving patient’s DHI score. Toupet et al. (2012) [29] also included movement restrictions as part of intervention. In the first phase, they randomized 226 participants between Epley maneuver and Semont-Toupet maneuver up to two times and those who did not present liberatory signs received an alternate maneuver. After this, they stopped maneuvers, regardless of results. Then they randomized all 226 patients into restriction and no restriction groups. In their outcomes, the authors concluded that movement restrictions after maneuver did not have an influence on Visual Analogue Scale (VAS) for vertigo and dizziness [29]. This and the Mandalà et al. (2011) [28] studies were the only ones in the present review to approach liberatory signs (vertigo and nystagmus) after maneuver as a success criterion. According to the findings of these studies, the movement restrictions after ORM do not influence outcomes [29,31,32,34]. These data are in concordance with the international guideline elaborated by Fife et al. (2008) [40], which classified movement restrictions as “Recommendation U”, and with Moon et al. (2005) [48]. Therefore, there are not enough data to support its use in clinical practice. In relation to in-home treatment, the self-maneuver presented better outcomes when associated to Epley maneuver, but the addition of movement restrictions did not influence the results. According to number of maneuvers, the studies that used ORM varied from 1 to 3 maneuvers in general. Two studies performed a single maneuver and obtained good results in the treatment of BPPV immediately or 72 hours after maneuver’s performance [32,33]. One study applied 1 to 3 maneuvers in the same session [30]; one applied 2 consecutive maneuvers in the same session [31]; and another one performed 2 maneuvers with 7-minute intervals [29]. If still needed, another maneuver was performed. The outcomes of these three last studies demonstrated that ORM was effective in the treatment of BPPV. Three studies performed one maneuver per session with a range of 1 to 3 maneuvers (sessions) among groups and concluded that the ORM was effective for symptom remission [27,28,34]. Korn et al. (2007) [49] compared a middle-aged sample group who underwent one maneuver per session to another one who received 4 maneuvers in the same session, with two-minute intervals, plus one weekly maneuver. They concluded that consecutive maneuvers in the same session seem to be more effective than only one maneuver per session. On the other hand, Kasse et al. (2012) [12] conducted a quasi-experimental study in 33 older patients with BPPV and performed the ORM only once per session, then repeated weekly until symptoms and nystagmus disappeared (remission), and also concluded that ORM was effective. Wolf et al. (1999) [50] affirm that although the elderly population is more exposed to BPPV, the maneuver’s efficacy is the same for all ages. Despite ORM being an effective intervention for BPPV in 52 elderly, regardless of the protocol performed by the studies, it is not possible to propose a standard number of maneuvers, or if they should be performed in the same session or in different ones. Only one study that did not use ORM as therapeutic proposal was found [35], but its main intervention was VR exercises for an elderly sample. They applied Cawthorne and Cooksey exercise protocols associated to Gingko-Biloba in experimental group and only drug intervention in the control group. The authors obtained significant improvement referring to functionality by performing therapeutic exercises; however, there are not reports denoting improvements in BPPV symptoms and signs (vertigo and nystagmus). Angeli et al. (2003) [30] also used VR exercises in elderly people with BPPV (particles- dispersing and customized habituation exercises). In the first part of the study, patients were randomly assigned into 2 groups: ORM and no treatment. After one month, those patients who did not respond to treatment were enrolled in the second part of the study and were treated with an individualized combination of CRM and VR, and then reevaluated 3 months later. The authors concluded that the maneuvers are more effective compared to no treatment, and VR exercises can be added to ORM to improve results in the treatment of BPPV in elderly people. Furthermore, Angeli et al. (2003) [30] observed a considerable rate of symptoms recurrence in elderly who only underwent ORM and they suggest that VR exercises can decrease recurrence rate of BPPV. They stated that this protector effect can be more evident in elderly people [30]. Some studies have shown that VR exercises in younger and older patients with BPPV are more effective alone when compared to no treatment or placebo treatment [51,52]. Silva et al. (2011) [21] analyzed two international guidelines [40,53] and considered VR exercises as possibly effective, becoming a secondary option in the treatment of BPPV. Although postural balance is often impaired in the elderly, especially in those with vestibular disorders [7,18], it was observed that none of the studies evaluated static and/or dynamic postural balance in this population. Chang et al. (2008) [39] had positive effect on postural balance of subjects treated with personalized VR associated to ORM in their clinical trial when compared to those who only underwent maneuvers. However, the average age of their patient population was < 60 years. Nonetheless, quasi-experimental studies demonstrate the efficacy of ORM in improving balance in this population [12,45,54]. Ganança et al. (2010) [18] performed a study on elderly people and concluded that the number of falls decreased in consequence of vertigo and nystagmus remission after a maneuver. In this review, two studies assessed functionality [27,35], and another one evaluated quality of life [34]. The majority of selected articles provide short-term results ranging from 72 hours to 5 weeks postfollow up. Only the study of Salvinelli et al. (2004) [27] presented a longer follow up of six 53 months and they observed a higher rate of symptom recurrence (21,1%) in none treatment group compared to the ORM group (3.8%) [55]. Ganança et al. (2010) [18] reevaluated an elderly sample in their quasi experimental study after one year of successful ORM and observed BPPV recurrence rate of 21.5%. According to Brandt et al. (2006) [56] and Simhadri et al. (2003) [57], the recurrence rate in treated cases varies between 10% and 80%. This variability found in literature in relation to BPPV recurrence rate may occur due to methodology differences among studies. Ganança et al. (2010) [18] believe that the longer the follow up is, the higher the proportion of recurrence rate of BPPV cases is. Although results of BPPV treatment are encouraging, the recurrence of dizziness, particularly in the elderly, is very high and new studies with long term follow up would be necessary for these patients [6-8]. The review’s limitations include the methodological quality of the studies and the lack of function, postural balance and quality of life measures. This review has accepted 60 as an average age for elderly people, however the standard deviations are high, which means there are middle-aged persons in some studies. All the studies that used ORM in elderly people with BPPV showed a trend of improvement in their symptomatology, mainly for nystagmus, vertigo and dizziness. Regardless of the protocol performed by the studies, it is not possible to propose a standard number of maneuvers, or if they should be performed in the same session or in different ones. 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American journal of otolaryngology 24 (6):355-360 57 ARTIGO 2 58 "Positive to Negative" Dix-Hallpike test and Benign Paroxysmal Positional Vertigo recurrence in elderly undergoing Canalith Repositioning Maneuver and Vestibular Rehabilitation Karyna Myrelly Oliveira Bezerra de Figueiredo Ribeiro1, Lidiane Maria de Brito Macedo Ferreira2, Raysa Vanessa de Medeiros Freitas3, Camila Nicácio da Silva4, Nandini Deshpande5, Ricardo Oliveira Guerra1,6 1 Physiotherapist, Doctor, Post-Graduation Program in Health Sciences, Federal University of Rio Grande do Norte, Brazil 2 Physician, Master, Post-Graduation Program in Public Health, Federal University of Rio Grande do Norte, Brazil 3 Physiotherapist, Bachelor, Department of Physiotherapy, Federal University of Rio Grande do Norte, Brazil 4 Physiotherapist, Master, Department of Physiotherapy, Post-Graduation Program in Physiotherapy, Federal University of Rio Grande do Norte, Brazil. 5 Physiotherapist, Doctor, Faculty of Health Sciences, School of Rehabilitation Therapy, Queen's University, Canada 6 Physiotherapist, Doctor, Post-Graduation Program in Physiotherapy, Federal University of Rio Grande do Norte, Brazil Corresponding author Karyna Myrelly Oliveira Bezerra de Figueiredo Ribeiro, Department of Physiotherapy, Federal University of Rio Grande do Norte, Brazil, Senador Salgado Filho Avenue, n 3000, Campus, CEP: 59078-970, Natal/RN, Brazil, Phone: +55 (84) 3342-2001. [email protected] ABSTRACT Introduction: Benign Paroxysmal Positional Vertigo is the most common cause of dizziness in elderly. Recent studies have shown that elderly people present higher Benign Paroxysmal Positional Vertigo recurrence and that vertiginous symptomatology remission varies according to comorbidities and the applied therapeutic techniques. Objective: To assess the short-term effectiveness of Vestibular Rehabilitation in addition to Canalith Repositioning Maneuver on positive to negative Dix-Hallpike test, on recurrence and number of maneuvers to achieve a negative test in elderly patients with chronic Benign Paroxysmal Positional Vertigo. Methods: In this randomized controlled trial, 7 older adults (average age: 69 years, range 65-78) underwent Canalith Repositioning Maneuver and Vestibular Rehabilitation for thirteen weeks. Seven older adults (average age: 73 years, range 65-76) in the control group received only Canalith Repositioning Maneuver. The participants were assessed at baseline (T0), one (T1), five (T5), nine (T9) and thirteen weeks (T13). The differences between the groups were assessed by Mann-Whitney and Fisher exact tests, and the Friedman and Wilcoxon tests were used to determine the intragroup differences. Results: No significant differences were found between groups for the positive to negative Dix-Hallpike test, recurrence and number of maneuvers to achieve a negative test. The number of maneuvers to achieve negative Dix-Hallpike test was lower in intragroup comparisons in the experimental group. Conclusion: The findings suggest that additional Vestibular Rehabilitation did not influence the positive to negative Dix-Hallpike test, recurrence or number of maneuvers to achieve a negative test in elderly patients with chronic Benign Paroxysmal Positional Vertigo. Key words: elderly, vestibular diseases, rehabilitation. 59 INTRODUCTION Dizziness is a common symptom, especially in the elderly. It is estimated that 30% of people over the age of 65 complain of dizziness. The rate of annual consultations due to dizziness in primary care increases from 8% for individuals aged 65 years or older to 18% among those aged 85 or older (1, 2). In elderly patients, this symptom is considered a geriatric multifactorial syndrome, caused by the physiological processes of aging and/or pathological processes (3-6). Benign Paroxysmal Positional Vertigo (BPPV) is the most common cause of dizziness in the adult population; approximately 30% of seniors over the age of 70 will experience at least one episode of BPPV throughout their life (7, 8). BPPV is classified according to its nature, in primary or idiopathic (considered the most common form of the disease) (9), or secondary. The main causes for secondary BPPV are: traumatic brain injury, post-operative ear surgery, vertebrobasilar insufficiency, vestibular neuronitis, Ménière's disease or metabolic disorders (10). BPPV recurrences are associated with known risk factors such as diabetes mellitus, hypertension, osteoporosis and osteoarthritis (11). Posterior canal BPPV is considered the most common type of the disease, and is diagnosed by DixHallpike test (12). The treatment can be based on non-pharmacological measures, highlighted by the Canalith Repositioning Maneuver (CRM) or modified Epley maneuver, a therapeutic recommendation with strongly proven evidence, and Vestibular Rehabilitation (VR) as a secondary option (13, 14). The objectives of the study were to analyze the effectiveness of VR associated with the CRM compared to CRM in a "positive to negative" Dix-Hallpike test, BPPV recurrence and the number of maneuvers to achieve a negative test in elderly patients with chronic BPPV. In addition, to trace the clinical profile of elderly with chronic BPPV and descriptively evaluate the associations of this (profile) with risk factors described in the literature. METHOD This is a randomized, single-blind, two-arm controlled trial that followed the recommendations established by the CONSORT (Consolidated Standards of Reporting Trials), 2010 (15), being recorded in the REBEC (Registro Brasileiro de Ensaios Clínicos) under number: RBR-7jkbyg. It was approved by the local Ethics Committee in Research, protocol 543/11 in accordance to resolution 196/96. Seniors with chronic BPPV (minimum of 6 months) were referred from the otoneurology outpatient clinic of a university hospital and from other public and private services of medical specializations that treat patients with complaints of dizziness. The study included individuals aged 65 years and older; having a positive Dix-Hallpike test with vertigo accompanied or not with positional nystagmus (objective or subjective BPPV). Exclusion criteria were: presence of cervical neurological symptoms, limited cervical amplitude of movement and instability for the implementation of both the diagnostic Dix-Hallpike test and CRM, systemic diseases (such as hypertension, diabetes mellitus and thyroid dysfunction) with no medication control, motor, hearing or visual restrictions that prevent proper conduction of body balance evaluation and VR protocol, subjects not being able to understand and respond to simple verbal commands, having undergone previous treatment with CRM and were performing some physical activity such as: muscle strengthening, pilates, yoga or high intensity aerobic exercises. Seniors who had some serious health complications which prevented the continuation of treatment or who did not want to continue the instituted therapy were also excluded from the study. Participants were informed about the procedures and objectives of the study and those who agreed to participate were asked to sign the Informed Consent Form. 60 After screening for the definition of the inclusion and exclusion criteria, the randomization process was performed in blocks with a sequence generated by a computer program (www.randomization.com). Patients were then randomized into two groups: 1 - Control Group (CG) - CRM; and 2 - Experimental group (EG) - CRM and additional VR. The process of randomization and allocation was done by an independent researcher not involved with clinical trial. The evaluations were performed by blinded investigators, different from those who carried out the VR protocol. Participants were assessed at baseline (T0) and at one (T1), five (T5), nine (T9) and thirteen (T13) weeks. A multidimensional clinical questionnaire was used to collect sociodemographic (age and sex) and anthropometric data (body mass index in kg/m2); anamnesis for BPPV with questions about nature (primary or secondary) and type of dizziness (16) (vertigo, floating sensation, disequilibrium or presyncope), dizziness time onset, Dix-Hallpike test (positive or negative), presence of nystagmus, affected side (right, left or bilateral), number of maneuvers, associated symptoms such as tinnitus; related health data, including comorbidities and medication use. Evaluation of BPPV recurrence was done taking into account the "positive to negative" Dix-Hallpike test with subsequent positive results in the 13-week assessment period. The classification for drug use was performed using the Anatomical Therapeutic Chemical Classification System (ATC), an alphanumeric coding system developed by World Health Organization (WHO) for the classification of drugs and other medical products. The classification was in accordance with the 2nd level (17). Polypharmacy occurrence was defined by concomitant use of five or more medications (18). Regarding the associated diseases, the classification system used was the International Classification of Diseases (ICD - 10). This is the international standard diagnostic classification for epidemiological and health administrative purposes, including analysis of the general situation of population groups and monitoring of incidence and prevalence of diseases and other health problems (19). Seniors were submitted to the Dix-Hallpike test (20, 21) with the aid of a Computerized Videonystagmoscopy Infrared System (SVNC, Contronic, Brazil), introduced to the least symptomatic side, according to information obtained from each patient. If patients failed to report which position was responsible for triggering vertigo, the test was initiated on the right side. Hence, the side that should be treated by CRM was identified. The eye movement was observed for 1 minute in search of nystagmus and the patient was asked about the presence of vertigo. The same procedure was repeated with the head rotated to the other side. To confirm the involvement of the posterior semicircular canal, nystagmus should last less than 1 minute and be of the superior torsional type for canalithiasis cases; and one minute or slightly more for cupulolithiasis (22, 23, 24). Cases where dizziness during testing was present with or without positional nystagmus association were accepted. The Epley maneuver was conducted in accordance with the description of Epley (1992), but none of the patients received premedication prior to treatment or applied mastoid bone vibration (25, 26). CRM was performed up to 3 times in the same session if signs and symptoms persisted (22, 23). Patients were warned that treatment could cause dizziness and nausea prior to each maneuver and they were asked to relax their neck muscles in order to prevent injury to the area. Orientations were given after completing the maneuvers. Next, CRM seniors were instructed to avoid rotation and extreme flexion-extension head movements, to avoid lying down on the affected side for 48 hours, and to elevate the head of the bed while sleeping for 24 hours (26). The medical assistant consented to suspend the anti-vertigo and anti-emetic preparations a week before the start of treatment. After one week (T1), the seniors performed the same initial evaluation protocol, and those who had positive Dix-Hallpike test were submitted to CRM again, in addition to VR protocol for seniors belonging to the EG. The same happened at five (T5), nine (T9) and thirteen (T13) weeks after the initial assessment, totaling 5 assessments. The subjects of the EG performed customized VR based on other publications in the area (27, 28), twice a week for a period of twelve weeks, supervised by trained physiotherapists. The sessions lasted an average of 50 minutes. The main deficits and functional limitations were identified in the initial 61 assessment and the prescribed exercises were addressed to specific problems of the elderly (29). In customized exercise programs, the therapist regularly assesses the patient's progress and promotes feedback to the patient about the proper way to carry out the exercises. It is believed that this type of exercise increases patient adherence to treatment (30). VR included adaptation exercises (VORx1) and vestibular habituation (head and trunk repeated movements), static and dynamic balance training and lower limb muscle strengthening exercises. The exercise program aimed to stimulating the vestibular system and promoting sensory recalibration. During VR, therapists supervised exercises to ensure proper head and body movement in order to enhance results (according to the habituation precepts) and monitored wrong posture, promoting greater patient safety (27, 28) . For each prescribed exercise, a universal series containing 10 modifiers and progression patterns was followed in order to achieve the most challenging exercises. For more information, please see the detailed description previously published (27). Participants were instructed to report all complaints (for example dizziness, nausea or pain) during or after the exercises, which justified modifying the exercises, and to not do any other physical activity during the study. They were also encouraged to perform the exercises described in a booklet at home once a day. Statistical analysis The normality of the data was analyzed using the Shapiro-Wilk test. Fisher’s exact test was used to analyze the differences between groups at baseline regarding the distribution of sex, physical exercises performance and the presence of nystagmus, while the Mann-Whitney test was used to analyze differences between groups according to age, number of comorbidities, medication and dizziness time onset. The differences between groups regarding numerical results obtained at baseline (T0), one (T1), five (T5), nine (T9) and thirteen (T13) weeks were analyzed using the Mann-Whitney test. Fisher's exact test was also used for dichotomous variables (positive or negative Dix-Hallpike and recurrence). The nonparametric Friedman test was used to elucidate the differences in repeated intragroup measurements over time. The Wilcoxon test was used to compare intragroup improvement. All statistical tests were performed using version 20.0 of the Statistical Package for Social Sciences (SPSS) with statistical significance set at p <.05. RESULT Fourteen subjects were randomly allocated to one of the two groups, 6 women (6/7, 85.7%) and 1 man (1/7, 14.3%) with a median age of 69 years (65-78) were submitted to CRM whenever necessary and to VR for thirteen weeks in the experimental group. Five women (5/7, 71.4%) and 2 men (2/7, 28.6%) with a median age of 73 years (65-76) in the control group received only CRM. The research flowchart is shown in Figure 1. There were no statistical differences between groups at baseline for BPPV sociodemographic and clinical characteristics (p<.05). Body Mass Index (p=.720), dizziness time onset (p=.169), presence of tinnitus (p=1.000), presence of nystagmus (p=1.000), number of medications used by the elderly (p=.386), as well as the number of comorbidities (p=1.000) were also statistically similar for both groups at baseline. The median for the number of comorbidities in the experimental group was 4 (3-6) and in the control group 4 (2-6). The median number of drugs used was 3 (1-6) in the experimental group and 3 (3-7) in the control group. Other clinical characteristics of seniors participating in the study are presented in Chart 1. In assessing the "positive to negative" Dix-Hallpike test, it was observed that all seniors in the EG obtained negative results after 13 weeks. In contrast, the CG showed treatment failure in 2/7 (28.6%) 62 patients. Though, there was no difference (p>.05) between both groups throughout the testing period (Figure 2). Regarding the number of maneuvers performed in each session, no differences were found between the groups at baseline (T0), first (T1), fifth (T5), ninth (T9) and thirteenth (T13) weeks of assessment (p>.05). A significant improvement gradient can be observed only in the EG, with a progressive decrease in the number of maneuvers necessary for the treatment (Table 1). Two patients (2/7, 28.3%) in the control group and 1 (1/7, 14.7%) in the experimental group had recurrence of BPPV in the 13-week period. However, this fact did not favor the statistically significant difference between groups (p=1.000). Among the seniors who had recurrence, senior 1 had bilateral BPPV, hypertension as a risk factor for the disease and used 6 daily medications. Senior 6 had diabetes as a risk factor and used 3 daily medications. Senior 8 had secondary BPPV and remained feeling dizziness (floating sensation) after 13 weeks. There were no adverse events or complications of treatment, such as posterior canal BPPV being converted to horizontal canal BPPV. DISCUSSION Vestibular dysfunction is a major cause of dizziness in the elderly and represents 40-50% of the causes of dizziness in elderly patients referred to the otorhinolaryngologist. It is also described as an important differential diagnosis when the elderly falls without apparent cause (30). Chronically dizzy elderly have 53.3% of falls per year (31), and although vertigo corresponds to 25% of falls, it is separately disclosed as the most common cause (7). In a recent cohort study (32), it was observed that BPPV elderly patients exhibited 1.14-fold higher risk to fracture compared to healthy elderly, when adjusted for age, sex and comorbidities. Non-pharmacological alternatives for the treatment of BPPV, including CRM, represent an important therapeutic opportunity for not presenting risks of adverse effects usually present in the elderly that use pharmacological products. The treatment may be associated with VR, which includes vestibular adaptation, habituation and substitution exercises, associated with a set of procedures linked to changes in habits and postural improvement (21, 30, 33), despite the lack of substantial scientific providing evidence that VR enhances the effect of CRM or provides any benefit (13, 14). Our findings revealed that negative Dix-Hallpike test results or number of maneuvers to achieve it over the 13 weeks were not significantly different regardless of patients having performed additional VR therapy. However, it is important to mention that all patients in the EG obtained negative test results with consequent remission of vertigo after treatment with additional VR, unlike in the control group which was unsuccessful with two seniors. It might be suggested that these findings occurred due to the habitual performance of exercises incorporated into the VR program. Previous studies (23, 34) which performed vestibular habituation exercises in patients who had persistent BPPV symptoms after treatment through CRM reported good results with this combination therapy. BPPV recurrence is set at 1.7-fold higher risk in elderly patients with BPPV than in younger individuals suffering with the same disease (35). In this study, the prevalence of symptoms recurrence over the 13-week follow-up was 21.4%, corroborating with Dorigueto et al. (2009) (34). In the literature, however, the recurrence rate variability shows a result of 26% (34) to 50% (36, 37), which can be explained by the difference in time and patient follow-up mode. Choi et al. (2012) (38) observed that patients with BPPV presenting recurrence needed longer follow-up and CRM treatment periods when compared to groups that achieved rapid remission or symptom persistence. Of the three seniors who presented recurrence in this study, one had hypertension and one had associated osteoarthritis and diabetes. A recent multicenter study (11) demonstrated that the association 63 between two or more comorbidities such as hypertension, diabetes and osteoarthritis are able to significantly influence the number of BPPV recurrences and that osteoporosis is associated with a higher risk for such condition. Since this was a study conducted with elderly who have more comorbidities than the general population (39), the likelihood of recurrence is higher, because these associated diseases, recognized as BPPV triggers, are more present in these individuals. BPPV can recur when secondary to some neurological or otological event. In this study, the only senior who had secondary BPPV (which was due to prolonged bed rest from being in a coma, also considered a triggering event to BPPV) (40) had recurrence. Cases of recurrence and persistence of BPPV mostly result from the idiopathic form of the disease. Additionally, individuals suffering from secondary BPPV are more likely to present vertigo symptoms for a longer time, and even after dizziness remission may have disease recurrence (38, 41). It was found that more than half of the elderly were suffering from hypertension, hypercholesterolemia and arthritis, and that most also had osteoporosis and diabetes. Patients with BPPV have more vascular risk factors when compared to patients suffering from other vestibular diseases (42, 43). Furthermore, elderly patients with BPPV have 1.3-fold higher risk, adjusted by age and sex, to develop acute ischemic stroke than seniors who do not have the disease (44). Cardiovascular, metabolic and osteoarticular diseases, and osteoporosis are risk factors for the onset of BPPV, and may also be related to its genesis (7, 45-47). A considerable number of comorbidities per elderly was found. This may explain the low resolution of the symptomatology, since most of the surveyed elderly suffers from comorbidities that directly interfere with dizziness symptoms. The greater the number of associated diseases, the greater the risk for dizziness, especially if that number is greater than three (48, 49). The high number of associated diseases may be related to the fact that some seniors improved the vertigo symptom related to BPPV, but remain feeling another type of dizziness, which had occurred in five patients in this study (35.7%). Those participants remained with floating sensation dizziness even after a negative Dix-Hallpike test. The low number of subjects involved in the study can be considered as a potential limitation on the extrapolation of results found. However, the form of selection, and type (randomized controlled clinical trial) are considered strengths of the study. The findings of the intervention and its clinical implications must be wisely considered for making therapeutic decisions in elderly patients with BPPV. Despite differences between groups were not found, VR should be considered as an important adjuvant therapeutic tool, since the consequences arising out of BPPV such as falls and fractures in the elderly, can be potentially avoided through CRM associated with postural balance training exercises (32). We suggest further studies to evaluate the effectiveness of VR with larger sample sizes and longer-term follow-up, as vestibular functions may be influenced by confounding factors, which may cause a change in the health status of the elderly throughout treatment. CONCLUSION In the present study, elderly patients with BPPV were mostly women and had a considerable number of comorbidities. The findings suggest that "positive to negative" Dix-Hallpike test, BPPV recurrence and the number of maneuvers to achieve negative results were not influenced by additional VR to CRM in the elderly with chronic BPPV. Conflicts of interest: The authors declare no conflicts of interest. 64 REFERENCES 1. 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Clinical evaluation of elderly people with chronic vestibular disorder. Braz J Otorhinolaryngol. 2006;72(4):515-22. 46. Bittar RS, Pedalini ME, Ramalho JO, Yoshimura R. Critical analysis of vestibular rehabilitation outcome according to dizziness etiology. Braz J Otorhinolaryngol.. 2007;73(6):760-4. 47. Yu S, Liu F, Cheng, Z, Wang Q. Association between osteoporosis and benign paroxysmal positional vertigo: a systematic review. BMC Neurol. 2014;14(110). 48. Gassmann KG, Rupprecht R, Group IZGS. Dizziness in an older community dwelling population: a multifactorial syndrome. J Nutr Health Aging. 2009;13(3):278-82. 49. Gomez F, Curcio CL, Duque G. Dizziness as a geriatric condition among rural communitydwelling older adults. J Nutr Health Aging. 2011;15(6):490-7. 67 Assessed for eligibility Enrollment (n=35) Excluded (n= 19) Screening Did not meet inclusion criteria (n= 19) Other reason (n=0) Allocation Randomized (n= 16) Allocated to intervention group (n= 08) Allocated to CG (n= 08) Received VR in addition to CRM Received CRM (n=08) (n=08) Did not receive allocated Did not receive allocated control (n=0) intervention (n=0) Baseline Assessment F o CRM l CRM l o w Follow-up in: Follow-up in: Additional VR and CRM, if (No additional treatment necessary and CRM if necessary) - 1 week (n= 08) 1 week (n= 08) u 5 weeks (n= 08) 5 weeks (n= 07) 9 weeks (n=07) 9 weeks (n=07) 13 weeks (n=07) 13 weeks (n=07) p Analysis Lost to follow-up Lost to follow-up (n = 01) (n = 01) 1. Personal problems 1. Fall Discontinued intervention Discontinued intervention Analyzed (n= 7) Analyzed (n= 7) Excluded from analysis (n= 0) Excluded from analysis (n= 0) Figure 01. Fluxogram of the study. CRM, Canalith Repositioning Maneuvers; VR, Vestibular Rehabilitation. 68 Chart 1. Characteristics of the elderly with BPPV sample during 13 weeks Type of dizziness 13th week No dizziness Diseases* Medications # Bilateral Type of dizziness Baseline Vertigo I10 J45 E78 Primary Right Vertigo No dizziness I10 E11 M81 M19 E02 No Primary Right Vertigo Floating sensation I10 N40 E78 CG No Primary Right Vertigo Floating sensation F CG No Primary Left Vertigo No dizziness 72 F CG Yes Primary Right Vertigo Vertigo Pat 7 65 F CG No Primary Right Vertigo Vertigo N40 E11 M19 J32 E78 K-29 I10 M19 I48 G47.3 M81 H40 M19 E11 F32 E78 I10 M81 A11 B01 C03 C10 R01 R03 A10 A11 B01 C03 C09 H03 M05 C03 C07 C09 C10 G03 A02 C02 C10 Pat 8 65 F EG Yes Secondary Right Vertigo Floating sensation Pat 9 65 F EG No Primary Right Vertigo No dizziness Pat 10 66 F EG No Primary Left Vertigo No dizziness Pat 11 73 F EG No Primary Bilateral Vertigo Floating sensation Pat 12 78 F EG No Primary Right Vertigo No dizziness Pat 13 70 F EG No Primary Right Vertigo No dizziness Pat 14 69 F EG No Primary Right Vertigo Floating sensation Age Sex Group Recurrrence Type of BPPV Affected side Pat 1 72 F CG Yes Primary Pat 2 74 F CG No Pat 3 73 M CG Pat 4 76 M Pat 5 74 Pat 6 E07 F32 H40 I10 M81 E78 F32 M79.7 I10 M81 F32 J42 K29.3 I87.2 M19 M81 E02 K74 I10 M19 I49 M19 J45 K29.3 E16 E78 M79.7 F32 E78 C03 C07 S01 A10 N02 N06 C08 M05 A11 N06 S01 A11 C09 C10 N06 A11 M05 N03 R01 R03 H03 C01 C03 C09 A02 A10 C10 M05 R01 R03 C10 N05 N06 69 CG – Control Group; EG – Experimental Group. * E02 – Subclinical iodine-deficiency hypothyroidism, E 07 – Other disorders of thyroid, E11 – Type 2 diabetes mellitus, E 16 - Other disorders of pancreatic internal secretion, E78 –Hypercholesterolemia, F.32- Depressive episode, G47.3 – Sleep apnoea, H40 – Glaucoma, I10 – Essential hypertension, I48 – Atrial fibrillation and flutter, I 49 – Other cardiac arrhythmias, I87.2 – Venous insufficiency (chronic)(peripheral), J32 – Chronic sinusitis, J42 – Unspecified chronic bronchitis, J45 – Asthma, K29.3 – Chronic superficial gastritis, K74 – Fibrosis and cirrhosis of liver, M19 – Other arthrosis, M32 – Systemic lupus erythematosus, M79.7 – Fibromyalgia, M81 – Osteoporosis without pathological fracture, N40 – Hyperplasia of prostate. # A02 – Drugs for acid related disorders, A10 – Drugs used in diabetes, A11 – Vitamins, B01 – Antithrombotic agents, C01 – Cardiac therapy, C02 – Antihypertensives, C03 – Diuretics, C07 – Beta blocking agents, C08- Calcium channel blockers, C09 – Agents acting on the reninangiotensin system, C10 – Lipid modifying agents, G03 – Sex hormones and modulators of the genital system, H03 – Thyroid therapy, M05 – Drugs for treatment of bone diseases, N02 – Analgesics, N03 – Antiepileptics, N05 – Psycholeptics, N06 – Psychoanaleptics, R01 – Nasal preparations, R03 – Drugs for obstructive airway, S01 – Ophthalmologicals. 70 Figure 2. Descriptive analysis of the "positive to negative" Dix-Hallpike test at baseline (T0), first (T1), fifth (T5), ninth (T9) and thirteenth week (T13) of assessment. 71 Table 1. Number of maneuvers performed per session in experimental and control groups at baseline (T0), first (T1), fifth (T5), ninth (T9) and thirteenth (T13) week of assessment. Outcome Measures Median (range) Number of Maneuvers Experimental Group (n=7) T0 T1 T5 3 (2-3) 3 (0-3) 0 (0-3) a Control Group (n=7) T9 T13 p* T0 T1 T5 T9 T13 p* 0 (0-2) ab 0 (0-0) ab .0001 2 (2-3) 2 (0-3) 0 (0-3) a 0 (0-3) 0 (0-3) a .073 a Significant intragroup difference compared to T0, p<.05 b Significant intragroup difference compared to T1, p<.05 * Intragroup comparison 72 ARTIGO 3. EFFECTS OF BALANCE VESTIBULAR REHABILITATION THERAPY IN ELDERLY WITH BENIGN PAROXYSMAL POSITIONAL VERTIGO: A RANDOMIZED CONTROLLED TRIAL Karyna Myrelly Oliveira Bezerra de Figueiredo Ribeiro1,2, Raysa Vanessa de Medeiros Freitas2, Lidiane Maria de Brito Macedo Ferreira3, Nandini Deshpande4, Ricardo Oliveira Guerra1,5 1 PhD, Post-Graduation Program in Health Sciences, Federal University of Rio Grande do Norte, Brazil. 2 B.Sc.P.T., Department of Physical Therapy, Federal University of Rio Grande do Norte, Brazil. 3 MSc, Post-Graduation Program in Public Health, Federal University of Rio Grande do Norte, Brazil. 4 PhD, Faculty of Health Sciences, School of Rehabilitation Therapy, Queen's University, Canada. 5 PhD, Post-Graduation Program of Physical Therapy, Federal University of Rio Grande do Norte, Brazil. Corresponding author: Karyna Ribeiro, Departament of Physical Therapy, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Senador Salgado Filho Avenue, 3000, Brazil. Phone number: +55 84 99986-7237 Email address: [email protected] 73 ABSTRACT Purpose: To evaluate short-term effects of balance Vestibular Rehabilitation Therapy (VRT) on balance, dizziness symptoms and quality of life of the elderly with chronic Benign Paroxysmal Positional Vertigo (BPPV). Method: This is a randomized, single-blind, controlled trial with older adults with chronic BPPV were randomized into two groups, the experimental group (n=7, age: 69 (65-78) years) and the control group (n=7, age: 73 (65-76) years). Patients in the experimental group underwent balance VRT (50 min per session, 2 times a week) and Canalith Repositioning Maneuver (CRM) for thirteen weeks. The control group was treated using only CRM. Standing and dynamic balance, dizziness symptoms and quality of life were measured and at the baseline, and at one, five, nine and thirteen weeks. Results: There were no between-group differences in dizziness, quality of life and standing balance over the 13 weeks of evaluations. Significant differences were observed in dynamic balance measures between groups (p˂.05 for most tests) through follow-up assessments. In intragroup analysis, both groups showed improvements in all measurements, however no differences were found in the control group regarding dynamic balance. Conclusions: The patients who received additional balance VRT demonstrated better results in dynamic balance than those who received only CRM. Key-words: dizziness, aged, benign paroxysmal positional vertigo, postural balance, rehabilitation. 74 INTRODUCTION Benign Paroxysmal Positional Vertigo (BPPV) is the most common otoneurological condition found in the adult population, affecting 64/100000 persons per year [1]. About 25% of people 70 years or older who suffer from dizziness are diagnosed with BPPV [2], presenting symptoms that persist for more than one year [3]. The lifetime prevalence is estimated at 2.4% and previous year prevalence at 1.6% in patients 60 years old or older, which is seven times higher than those aged 18 to 39 years [1]. BPPV is characterized by rotational and rapid dizziness (vertigo) triggered by head movements, such as cervical hyperextension and/or rotation. Vertigo symptomology is caused by statoconia displacement from macula of the utricle, which either floats freely in one or more semicircular canals endolymph or gets attached in the semicircular canal cupules (cupulolithiasis), provoking vestibular disturbance during sudden head movements [2,4,5]. As a result, BPPV patients present balance difficulties in positions that involve head movements [2]. Consequently, these balance deficits contribute to several physical and emotional impairments in this population [6]. There is strong scientific evidence that supports Canalith Repositioning Maneuver (CRM) for improvement in vertigo and nystagmus in BPPV patients [2,5,7-9]. Studies also affirm short-term balance improvement in patients with BPPV after CRM intervention [1012]. However, some authors indicate that CRM is not sufficient to improve or recover postural stability in elderly people with BPPV [4,7,13]. Balance Vestibular Rehabilitation Therapy (VRT) is a non-pharmacological therapeutic resource for patients with balance disturbances. Its positive impact on balance is based on mechanisms related to the central nervous system’s neural plasticity and its objectives are to promote visual stabilization, improve vestibular-visual interaction during head movements, consequently improving standing and dynamic postural stability in conditions that produce conflicting sensory information, and decrease sensitivity to head movements [14]. It is an otoneurological treatment method largely accepted in literature due to its favorable results evidenced in several studies [14]. Up to date, there are no randomized clinical trials for evaluating usefulness of VRT for elderly people with BPPV. Therefore, the objective of this study was to 75 compare short-term effects of VRT in addition to CRM to only CRM on balance, dizziness symptoms and quality of life (QL) in elderly subjects with chronic BPPV. METHODS Design: In this single-blind, randomized, controlled clinical trial, elderly with diagnosis of BPPV were referred from the otoneurology outpatient clinic of university hospital and other public and private services of medical specialties that treat patients with complaint of dizziness. This clinical trial is recorded in the Brazilian Clinical Trials (RBR-7jkbyg) and it was approved by the local Ethics Committee in Research, protocol 543/11 in accordance to resolution 196/96. Patients: The sample comprised of patients 65 years old or more with diagnosis of chronic objective or subjective BPPV (minimum 6 months). The inclusion criteria was the presence of vertigo during Dix-Hallpike test that may or may not be accompanied by nystagmus. However, potential participants who had other neurological conditions (e.g. peripheral neuropathy, stroke, Parkinson disease) and/or orthopaedic problems (e.g. severe osteoarthritis of knee or lower extremity deformity) were excluded to eliminate confounding factors affecting balance performance. Further, those with uncontrolled metabolic diseases (hypertension, diabetes mellitus, thyroid problems); unable to understand and answer a simple verbal command; previously underwent either CRM or balance VRT exercises; neck disturbances that prevented them from performing the maneuver were also excluded. Patients who were already performing structured physical activities such as muscle strengthening exercises, pilates, yoga or high intensity aerobic exercises were also excluded. All eligible participants gave informed and signed consent. Procedure and randomization: The participants were randomly assigned into two groups: the control group, which underwent CRM; and the experimental group which underwent balance VRT in addition to 76 CRM. The randomization program was computer generated using a basic random number generator in blocks. The allocation sequence was concealed by an independent researcher. Group allocation was concealed from the assessors until the end of the study. Sample randomization and allocation was performed by a researcher who was not directly involved in the assessment or intervention of patients. A sealed envelope identifying the group of each participant was given to the therapists to inform them of the allocation. Two assessors blind to the subject’s group assignment evaluated all participants at baseline and after one, five, nine and thirteen weeks, and performed the CRM as needed. The Dix-Hallpike test was performed after each follow up assessment to check if it was still positive and CRM were performed as needed. The Computerized Infrared Videonystagmoscopy (VNC, Contronic, Brazil) was used to measure nystagmus features, both during Dix-Hallpike test and CRM. Since both interventions were rehabilitation therapies (required active patient’s participation) it was not possible to blind neither patients nor therapists involved in the exercise treatment during research. Interventions: Participants from both groups received the modified Epley CRM [15,16] during the thirteen weeks as needed in each evaluation. CRM was performed by physiotherapists with 2 years experience in the modified Epley maneuver. Since CRM has a very high reported cure rate, we believed it was ethically appropriate to provide all patients this treatment. Prior to each treatment, it was explained to the subjects that the treatment might provoke vertigo and nausea and they were asked to relax their neck muscles. CRM was repeated up to three times during a session, as necessary, attempting to fully resolve all dizziness symptoms. Standard post-procedure instructions were given to both treatment groups (keep their head upright, not to bend over and sleep while propped up in high headboard for 24 hours and to avoid lying down on the affected side for 48 hours) [17]. The CRM was performed as initially described by Epley [18], however, none of the patients received premedication before treatment, nor was a mastoid vibrator used. Studies showed no higher benefit when mastoid vibration was added to CRM [5]. For modified Epley maneuver, the patient was placed in an upright sitting position with the head turned to the affected ear and lowered into the supine position with the 77 head-hanging beyond the bed approximately 30º. In this position, nystagmus was identified and symptoms were noted. Then, the head was turned 90º to the unaffected side (from 45º of rotation to affected side to 45º of rotation to the unaffected side). Following this rotation, patients maintained head’s rotation and rolled their trunk to the unaffected side, facing the floor. Then, the patient was brought slowly into an upright sitting position, completing the maneuver. Each position was hold for 30 to 60 seconds or until resolution of symptoms and/or nystagmus [15,16]. Patients in the experimental group also received customized balance VRT, based on previous publications of balance vestibular rehabilitation exercises [19,20], that was performed twice a week, 50 minutes each, over a 12 week period. The program was supervised by one physiotherapist with 2 years experience in balance VRT area and one trained assistant. The main impairments and functional limitations were identified during the initial evaluation and customized exercises were customized to each patient [21] and prescribed using a problem-oriented approach [22]. With customized exercise plan, the therapist regularly assesses patient progress and provides ongoing feedback to the patient regarding proper way to perform the exercises. It is believed this kind of exercise increases the patient’s compliance [23]. The balance VRT included oculomotor exercises (VORx1), habituation exercises (repeated head and trunk movements), standing and dynamic balance training, along with lower-limb muscles strengthening. The primary aim of the exercise program is to stimulate the vestibular system and to promote sensory reweighting. When somatosensation, vision or vestibular function is lost or reduced, the central nervous system readjusts to become more reliant on the 2 remaining intact modalities. Therefore, during vestibular rehabilitation the patient is repeatedly exposed to various sensory information so the brain can optimize postural responses to maintain balance [23]. For each exercise prescription, a universal set of 10 modifiers and progression patterns were followed to make the exercises more challenging [17]: (1) the posture in which the exercise is performed (2) the type of support surface (3) the size of the base of support (4) the positioning of the trunk (5) position of the arms (6) the direction of head movements (7) the 78 direction of whole body movements (8) the visual input (9) the presence or absence of the dual cognitive task (10) any other special circumstances, such as target distance (near or far) when performing VORx1 exercise. Participants were instructed to report any complaints during or after performing the exercises (e.g. dizziness, nausea or muscle soreness), reasons for modifying the prescribed exercises, if they modified them. They were also instructed not to start any new physical activity while in the study. They were also encouraged to perform the exercises described in a booklet at home (once a day). Outcome Measures: All participants were evaluated at the baseline and one, five, nine and thirteen weeks by the same blinded assessor. The following demographic and health related information was recorded at baseline: age, gender, body mass index (kg/m²), dizziness time onset, presence of nystagmus in Dix-Hallpike test, number of comorbidities using CID-10 criteria [24], number of medications, physical exercise performance and dominant side. Primary outcome: Standing balance was measured using the Center of Gravity (COG) sway velocity (degrees per seconds) of the modified Clinical Test of Sensory Interaction on Balance (mCTSIB) and mean COG sway velocity (degrees per second) of Unilateral Stance test (US). The mCTSIB examines postural sway under 4 conditions: stance on firm surface with eyes open and eyes closed and stance on foam surface with eyes open and eyes closed up to 10 seconds each. In the US test, subjects were tested using the dominant leg with eyes open and closed. Each test consisted of three trials in each condition, each lasting up to 10 seconds. Dynamic balance was measured as the average speed of COG in movement velocity (degrees per second) and the maximum excursion in percentage of the Limits of Stability (LOS), the Walk Across (WA) speed in centimeters per second and Tandem Walk (TW) end COG sway velocity in degrees per second. In LOS measures, targets represent the maximum theoretical distance that individuals are capable of shifting the COG without losing balance or changing the position of their feet. LOS movement velocity is represented by the mean 79 dislocation COG velocity during the 8 seconds of the test and LOS maximum excursion was the higher distance achieved during the trial. In WA test, subjects were instructed to perform casual gait on force plate and their forward progression was quantified. In TW test, subjects were instructed to stand heel-to-toe steadily at the starting position, walk as quickly as possible and stop still at the end of the force plates. Both tests consisted of three trials, each lasting for 10 seconds. End sway velocity was measured when the forward progression had stopped. These tests were measured by the Balance Master System® (Neurocom International, Inc., USA). The subjects stood on the dual force plates with a standard foot position provided by Balance Master System® and faced a screen. The balance in dynamic tasks was assessed by the Brazilian version of Dynamic Gait Index (DGI) [25]. DGI is a functional gait scale composed of eight items with varying walking demands (casual gait, gait at different speeds, gait with vertical and horizontal head turns, walk over and around objects, making a 180° turn, and stair climbing) [25]. The DGI total score range from 0 points (severe impairment) to 24 (normal performance) with a cutoff score ˂ 19 points for fall risk [26]. All functional assessments of balance were carried out by two physiotherapists to provide more confidence to the participants. Secondary outcome: Subjects rated their intensity of dizziness using a 10-cm Visual Analogue Scale (VAS) for dizziness ranging from no symptoms (0cm) to the worst possible symptoms (10cm) [27]. The Brazilian version of Dizziness Handicap Inventory (DHI) was used to compare the impact of BPPV in quality of life before and after treatment [28]. DHI is a self-reported instrument, which evaluates the influence of dizziness and unsteadiness on the quality of life of patients with vestibular disorders [28]. The questionnaire consists of 25 items, divided into a seven-item physical subscale, a nine-item emotional subscale and a nine-item functional subscale. The total score ranges from 0 points (no handicap) to 100 points (severe handicap). A reduction in the score ≥ 18 points following treatment is considered significant improvement in the quality of life [29]. Since two illiterate patients were found in the 80 experimental group and two in the control one, the authors adapted the questionnaire by excluding question 07 (“because of your problem, do you have difficulty reading?”) which is related to physical subscales of literacy. Statistical analysis: Data normality was assessed using the Shapiro-Wilk test. Baseline group differences in sex distribution, physical exercise performance, presence of nystagmus and dominant side were analyzed by Fisher exact test and age, body mass index, dizziness time onset, number of comorbidities and number of medications were analyzed by Mann-Whitney test. We used the Mann Whitney test to analyze group differences with regard to numeric outcome measures obtained at the baseline, one week, five weeks, nine weeks and thirteen weeks. To elucidate the within group time effect during the interventions, the non-parametric Friedman test was carried out. The Wilcoxon signed-rank test was performed to compare within group improvement. The r value for the Mann-Whitney non-parametric test was performed to evaluate effect size of the interventions. All statistical tests were performed using Statistical Package for Social Science (SPSS) 20.0 version. Statistical significance was set at p <.05. RESULTS Patient recruitment occurred between January 2013 and January 2015. Out of 35 potential participants, 16 were allocated to one of the two study groups. Two participants voluntarily opted out along the course of the study; one in the experimental group at nine weeks assessment and one in the control group at five weeks assessment due to personal problems and a fall, respectively. Consort flow chart is shown in figure 1. Insert figure 1 about here Fourteen participants were included in this study, 7 in the experimental group (median age: 69, range 65-78) and 7 in the control group (median age: 73.5, range 72-76). There were more women than men in both the groups. Baseline characteristics in each group are 81 presented in Table I. No significant differences were found between the two groups at baseline for demographic and health related data, dizziness time onset, number of comorbidities, medications taken, and physical exercise performance. All p-values were >.05 (table 1). Insert table 1 about here No differences between groups were found regarding all standing balance aspects in sway velocity under mCTSIB and US conditions through follow up assessments. However, there was a within group improvement in standing balance in all mCTSIB foam surface conditions and in its composite score and in US test both eyes open and closed in experimental group (table 2). Concerning dynamic balance, there were significant differences between groups at nine week and thirteen week assessments in LOS maximum excursion, at five week and nine week assessments in WA speed test, at thirteen-week assessment in TW end sway velocity and from five weeks to thirteen weeks in DGI. However, no difference was found in LOS movement velocity. In within group comparisons, the experimental group’s all dynamic balance parameters significantly improved at follow-up assessments. Conversely, no significant differences were found regarding dynamic balance in control group (table 2). Insert table 2 about here Only WA speed at nine-week assessment showed a medium size effect among the variables that showed significant between group differences (r=.49). LOS maximum excursion at nine-week (r=.53) and thirteen-week (r=.55) assessments, WA speed at five weeks (r=.53), TW end sway velocity at thirteen-week evaluation (r=.65) and DGI score at five, nine and thirteen weeks (r=.60, r=.85 and r=.85, respectively) showed strong size effect. There were no significant differences in dizziness symptoms through VAS scores and quality of life according to all DHI sub-scales evaluations (physical, functional, emotional and total scores) at baseline, one week, five weeks, nine weeks and thirteen weeks. However, both 82 groups showed intragroup significant improvement at follow-up assessments for both outcome measures (table 3). Insert table 3 about here DISCUSSION This is a randomized controlled clinical trial, which examined the effects of additional balance VRT on intensity of dizziness, quality of life and static and dynamic balance for elderly patients with chronic BPPV after CRM. Patients’ scores ranged from 5 to 10 on VAS for dizziness at baseline indicating moderate to severe dizziness [30]. At 1-week assessment, patients obtained an improvement of 50% or more on vertiginous symptoms evaluated by VAS for dizziness in both groups. This finding shows that Epley maneuver alone provided immediate positive results on vertiginous relief [8,31]. Dizziness has a strong negative influence on quality of life of the patients who suffer from BPPV [32]. No differences were found on DHI domains between groups at follow-up assessments, which reiterates that Epley maneuver effectively ameliorates vertiginous symptoms [13,18,33], the major cause for decline in quality of life of BPPV patients [10]. In this study, physical subscale (e.g. to look up and to turn over in bed) was most affected by vertigo, followed by functional (e.g. to travel for business or recreation and to go for a walk without help) and emotional (e.g. to feel frustrated or embarrassed in front of others and to be afraid people might think someone is intoxicated) subscales, which corroborated findings from clinical trials with middle-aged subjects [6,10], adjusted by number of question in each one. Body balance maintenance depends on the integration of sensory information from the vestibular, visual and somatosensory systems [34]. Postural control may be influenced by agerelated physiological alteration, chronic disorders, pharmacological interactions or specific dysfunctions. The elderly people with vestibular disease have impaired static and dynamic postural balance, which predisposes them to falls [35-37]. It worsens further due to the extrinsic challenges associated with the environment, such as poor lighting, obstacles and 83 slippery floors [38]. VRT is a well-established and accepted intervention for persons with balance and vestibular disorders. It is described as effective in decreasing dizziness and improving functional independence [39-41]. Moreover, VRT re-weighs the sensory adaptive mechanisms in order to prioritize visual and somatosensation [42], once the training of different systems separately and combined leads the patient to learn to rely on the most appropriate sensory information [41]. However, no significant effect of additional VRT was found for mCTSIB test conditions at follow-up assessment and both groups presented a significantly smaller sway velocity composite score after treatment. This improvement could be attributed to CRM alone due the specific pathophysiology of BPPV. This outcome defers from Chang et al. (2008) [20] where the group who underwent additional Vestibular Rehabilitation exercises significantly improved their sway velocity on foam surface with eyes closed in middle-aged samples when compared to control group. Nonetheless, experimental group showed significant intragroup improvement in those sensory conditions that require a higher vestibular system’s demand for balance at 13 week when compared to all previous evaluations. BPPV patients present greater sway velocity when they undergo visual deprivation and changing proprioceptive inputs, once the vestibular system is heavily required to maintain balance. Inaccurate vestibular information from one side may cause ineffective sensory organization and abnormal vestibulospinal output, thereby resulting in increased sway in foam conditions [4,7]. Furthermore, patients with uncompensated unilateral peripheral vestibular dysfunction may have difficulty in maintaining an upright posture when both visual and proprioceptive inputs are damaged [43]. Despite those patients who underwent additional balance VRT did not have improved balance in the US compared to the ones who did not, we observed a trend of improvement in velocity sway in the experimental group on one foot with both eyes opened and closed. Greater sway velocity was noticed when standing in unilateral stance with eyes closed for both groups. US test is reported as the hardest test to achieve postural control due to base of support (BoS) reduction [3]. Thus, it is beneficial to introduce balance VRT that includes balance exercises to improve single leg stance on treatment of patients with vestibular 84 disorders [27], since this position is important to daily life activities, such as walking and climbing stairs. Visual and proprioceptive inputs are more important for patients with BPPV to use than those for healthy adults. Patients with BPPV also need to give more effort to sensory organization and muscle co-contraction to maintain single leg standing balance [7]. In this study, it is suggested that dynamic balance improved by balance VRT. To achieve it, a LOS control is needed. Elderly patients with vestibular dysfunction may present LOS reduction and use hip strategy for postural control maintenance, which may lead to functional impairment and increased fall risk. LOS limitations can be related to risk of falls or instability during COG displacement in activities that require leaning forward to reach for an object, leaning back to wash hair while bathing, and others [43]. Patients who underwent balance VRT showed better results than the ones who did not after treatment for maximum excursion LOS, which means they were able to be aware of their postural control pattern and to improve ankle movement control to perform a more favorable ankle strategy in order to project their COG to the determined target [41]. This improvement may suggest a reduction in the risk of falls, since their ability to control COG motion and regulate momentum was improved [44]. Lança et al. (2013) [45] showed that after one year of treatment with only CRM, elderly people presented worse scores in LOS when compared to initial evaluation. The authors suggest this result might be due to the sample age increasing associated with dizziness recurrence being directly harmed by the aging process. Casual gait speed assesses an older adult’s general health status and quality of life and provides a reliable information regarding risk of falling in elderly population [23]. Both gait speed in WA test and end sway velocity in TW improved in experimental group after balance VRT, which may be highlighted due to the fact that gait disorder (feeling of disequilibrium on walking) is one of the most common complaint in patients with vestibular disorders [36,46]. BPPV patients tend to decrease gait velocity and increase end sway velocity in TW when compared to healthy adults [7]. Furthermore, elderly people also require a larger BoS to maintain postural balance (age-related difference on weight transfer during unconstrained standing). Chang et al. (2008) [20] did not find a significant difference on TW test, but their study was not performed with only older people. At the end of TW, deceleration of the center 85 of gravity is required to hold a standing position. BPPV patients present a greater TW end sway velocity and an abnormal vestibulospinal output to stabilize trunk due to a vestibular dysfunction to detect linear deceleration [7]. DGI median at baseline was 16 or less for both groups, which indicates a high risk of fall in community-dwelling older adults [26]. Balance in dynamic tasks through DGI was improved by additional vestibular stimulated and balance exercises training in this study. At the end of the treatment, patients from experimental group achieved an improvement of 60% on DGI score. Improvement in dynamic balance due to additional VRT may positively contribute to activities of daily living performance of aged people enhancing their autonomy and to reduce fall risk. A recent cohort study [47] found that patients with BPPV showed a 1.14-fold higher risk of fracture when compared to patients without BPPV, adjusting for age, sex and comorbidities. The authors suggest to diminish the adverse outcomes of fractures in patients with BPPV and to reduce falls caused by BPPV itself Vestibular Rehabilitation (VR) is used. According to them, it includes (1) canalith repositioning therapy to flush the dislodged otolothic debris back into the utricle; and (2) balance retraining therapy to enhance central compensation, improve balance, and eliminate residual dizziness. The small sample size may be considered a potential limitation for our findings’ inference. Moreover, a long-term follow-up is required to evaluate the effectiveness of balance VRT, thus as the health status of the elderly as vestibular function are influenced over time by the aging process. In conclusion, older persons with BPPV who received additional balance VRT demonstrated better overall results in dynamic balance than those who received only CRM. There was also a trend (gradient) of improvement in standing balance measures in experimental group. However, findings suggest that dizziness symptoms and quality of life were not influenced by additional balance VRT. Further studied with larger sample size and longer follow-up periods are warranted. 86 IMPLICATIONS FOR REHABILITATION 1) Balance VRT in addition to CRM improves dynamic balance in elderly people with BPPV when compared to CRM alone. 2) Standing balance seems to be improved by balance VRT. 3) Balance VRT does not influence on dizziness symptomatology and quality of life. Acknowledgements We thank Dr Susan L. Whitney from University of Pittsburgh (USA) for her guidance on the study design and Dr Álvaro C. Maciel from Federal University of Rio Grande do Norte (Brazil) for his assistance on the study data analysis. Declaration of interest The authors report no conflicts of interest. 87 REFERENCES [1] von Brevern M, Radtke A, Lezius F, Feldmann M, Ziese T, Lempert T, et al. Epidemiology of benign paroxysmal positional vertigo: a population based study. J Neurol Neurosurg Psychiatry 2007;78:710-5. [2] Parnes LS, Agrawal SK, Atlas J. Diagnosis and management of benign paroxysmal positional vertigo (BPPV). CMAJ 2003;169:681-93. [3] Dorigueto RS, Mazzetti KR, Gabilan YP, Gananca FF. Benign paroxysmal positional vertigo recurrence and persistence. Braz J Otorhinolaryngol 2009;75:565-72. [4] Blatt PJ, Georgakakis GA, Herdman SJ, Clendaniel RA, Tusa RJ. The effect of the canalith repositioning maneuver on resolving postural instability in patients with benign paroxysmal positional vertigo. Am J Otol 2000;21:356-63. [5] Fife TD, Iverson DJ, Lempert T, Furman JM, Baloh RW, Tusa RJ, et al. 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Ann Intern Med 2000;132:337-44. [47] Liao WL, Chang TP, Chen HJ, Kao CH. Benign paroxysmal positional vertigo is associated with an increased risk of fracture: a population-based cohort study. Journal Orthop Sports Phys Ther 2015;45:406-12. 91 Assessed for eligibility (n = 35 ) Enrollment Excluded (n= 19) Did not meet inclusion criteria (n= 19) Refused to participate (n= 0) Other reason (n=0) Randomized (n= 16) Allocated to intervention group (EG) (n= 08) Received balance VRT in addition to Allocated to control group (CG) (n= 08) Received CRM maneuver (n=08) Allocation CRM maneuver (n= 08) Did not receive allocated control (n=0) Did not receive allocated intervention Baseline assessment F o CRM CRM Lost to follow up (n = 1) 1. Fall = 1 (CG) 1 week assessment (1-3 CRM if necessary) l l No additional treatment Balance VRT Discontinued intervention (n=0) o w 5 week assessment (1-3 CRM if necessary) u Balance VRT No additional treatment p 9 week assessment (1-3 CRM if necessary) Balance VRT No additional treatment Lost to follow up (n = 1) 1. Personal problems (EG) Discontinued intervention (n=0) 13 week assessment (1-3 CRM if necessary) Analyzed (n= 7) Excluded from analysis (n= 0) Analysis Analyzed (n= 7) Excluded from analysis (n= 0) Figure 1. CONSORT (Consolidated Standards of Reporting Trials) flow diagram. CRM, Canalith Repositioning Maneuver; VRT, Vestibular Rehabilitation Therapy, EG= Experimental Group; GC= Control Group. 92 Table 1. Baseline characteristic of participants*. Characteristics Experimental Group (n=7) Control Group (n=7) p-value Age (years), median (range) 69 (65 – 78) 73 (65 – 76) 0.073 Body Mass Index (kg/m2), median (range) 26.4 (23.9 – 35) 25.8 (20.9 – 30.4) 0.720 Sex Female Male 6 (6/7, 85.7%) 1 (1/7,14.3%) 5 (5/2,71.4%) 2 (2/7,28.6%) 1.000 2 (0.5 – 8) 4 (1 – 20) 0.169 5 (5/7, 71.4%) 2 (2/7, 28.6%) 5 (5/7, 71.4%) 2 (2/7, 28.6%) 1.000 median 4 (3 – 6) 4 (2 – 6) 1.000 Medication used number, median (range) 3 (1 – 6) 3 (3 – 7) 0.386 Physical exercise performance 0 to 3 days per week 4 to 7 days per week 6 (6/7, 85.7%) 1 (1/7, 14.3%) 4 (4/7, 57.1%) 3 (3/7, 42.9%) 1.000 Dominant Side Right Left 7 (7/7, 100%) 0 (0/7, 0%) 6 (6/7, 85.7%) 1 (1/7, 14.3%) 1.000 Dizziness time median (range) onset (years), Presence of nystagmus Yes No Comorbidities (range) number, Note. Values represent median (range), n% or otherwise indicated. * Mann - Whitney and Fisher exact test were used. 93 Table 2. Participants’ performance on standing and dynamic balance in between and within group comparisons for experimental and control groups at baseline, one week, five weeks, nine weeks and thirteen weeks. Outcome measures Median (range) Experimental Group (n=7) Control Group (n=7) Baseline 1 week 5 weeks 9 weeks 13 weeks p* Baseline 1 week 5 weeks 9 weeks 13 weeks mCTSIB (degrees/s) mCTSIB FIRM EO mCTSIB FIRM EC mCTSIB FOAM EO mCTSIB FOAM EC mCTSIB COMPOSITE 0.5 (0.3-1.1) 0.6 (0.2-1.7) 0.9 (0.7-2.4) 2.8 (1.4-3.3) 1.3 (0.7-4.5) 0.3 (0.1-1.3) 0.4 (0.2-1.7) 0.8 (0.5-1.9) a 2.3 (0.9-3.0) 1.2 (0.5-1.9) a 0.3 (0.2-0.7) 0.3 (0.2-0.9) 0.7 (0.5-0.8) a 1.3 (0.8-1.5) a 0.7 (0.5-0.9) a 0.4 (0.2-0.5) 0.4 (0.3-0.5) 0.7 (0.6-0.8) a 1.2 (1.0-1.5) a 0.7 (0.5-0.7) a 0.3 (0.2-0.6) a 0.4 (0.3-0.6) 0.7 (0.4-0.9) a 1.1 (0.3-1.3) a b c d 0.6 (0.4-0.7) a b 0.023 0.629 0.012 0.001 0.007 0.4 (0.1-0.7) 0.6 (0.3-1.3) 1.2 (0.6-1.6) 2.0 (1.0-6.0) 1.1 (0.6-2.3) 0.4 (0.2-0.5) 0.4 (0.1-0.7) 0.7 (0.4-1.0) a 1.3 (0.6-6.0) 0.6 (0.5-2.0) 0.3 (0.1-0.5) 0.3 (0.2-0.6) a 0.6 (0.3-1.3) 1.5 (0.4-6.0) a 0.8 (0.3-2.0) a 0.2 (0.0-0.6) 0.3 (0.1-0.6) 0.7 (0.3-1.1)a 1.4 (0.6-6.0) a 0.6 (0.3-1.9) a 0.3 (0.1-0.4)a 0.3 (0.2-0.4) a 0.7 (0.3-1.2)a 1.0 (0.5-6.0) a 0.6 (0.3-2.0) a 0.482 0.046 0.094 0.017 0.012 US sway (degrees/s) Eyes open Eyes closed 8.6 (1.1-12.0) 12.0 (8.5-12.0) 8.7 (1.3-12.0) 12.0 (8.7-12.0) 1.5 (1.0-12.0) b 12.0 (5.3-12.0) 1.2 (1.0-12.0) b 12.0 (5.1-12.0) 1.4 (0.9-12.0) b 12.0 (1.7-12.0) 0.004 0.040 12.0 (1.7-12.0) 12.0 (12.0-12.0) 5.3 (1.4-12.0) 12.0 (5.5-12.0) 8.5 (1.1-12.0) 12.0 (4.6-12.0) 8.6 (1.1-12.0) 12.0 (12.0-12.0) 8.5 (1.0-12.0) 12.0 (12.0-12.0) 0.121 0.406 Dynamic balance \ LOS MVL (degrees/s) MXE (%) 1.9 (0-3) 69 (0-82) 2.6 (1.7-4.6) 77 (48-89) 2.8 (2-4.5) a 80 (53-82) a 2.9 (2-3.9) a 85 (64-94) a c† 3.1 (1.5-3.9) a 79 (67-97) a† 0.009 0.029 2.0 (0.0-3.2) 48 (0-76) 2.1 (0.8-3.7) 58 (36-89) 2.6 (0.8-4.6) 58 (39-83) 2.3 (1.2-3.7) a 57 (45-89) 2.4 (1.8-4.6) 62 (53-79) 0.414 0.202 WA (m/s) Walk Across Speed 57.8 (22.4-80.8) 54.8 (36.9-84.5) 62.7 (49.6-79.1)† 60.3 (56.1-100.2) b† 60.3 (52.8-85.6) a b 0.007 51.0 (47.2-67.2) 51.4 (37.2-64.9) 50.5 (31.7-56.6) 53.2 (33.2-62.0) 56.2 (35.1-63.3) c 0.100 Tandem Walk (degrees/s) Tandem End Sway 7.8 (5.9-12) 7.0 (4.9-14.7) 5.2 (4.9-9.0) 4.9 (3.6-9.4) a b 4.9 (2.2-6.0) a b c† 0.002 7.4 (4.8-12.8) 6.3 (5.1-12.4) 8.2 (4.4-11.6) 5.2 (3.8-7.8) c 5.9 (5.1-6.5) 0.083 ad 0.093 p* Standing balance DGI 15 (8-22) 20 (12-22) a 23 (18-24) a b† 23 (22-24) a b† 24 (23-24) a b c† >0.001 16 (9-22) 19 (11-22) 18 (13-22) 19 (15-21) a 20 (17-22) † Significant difference between groups a Significant difference within group compared to baseline, p<0.05 b Significant difference within group compared to 1-week, p<0.05 c Significant difference within group compared to 5 weeks, p<0.05 d significant difference within group compared to 9 weeks, p<0.05 * within group comparison mCTSIB, modified Clinical Test of Sensory Interaction on Balance; EO, Eyes Open; EC, Eyes Closed; US, Unilateral Stance; LOS, Limits of Stability; MVL, Movement Velocity; MXE, Maximum Excursion; WA, Walk Across; DGI, Dynamic Gait Index. 94 Table 3. Participants’ performance on symptom (VAS) and quality of life (DHI) in between and within group comparisons for experimental and control groups at baseline, one week, five weeks, nine weeks and thirteen weeks. Outcome measures Median (range) Experimental Group (n=7) Baseline 1 week VAS 10 (6-10) 5 (0-8)a DHI Physical DHI Functional DHI Emotional DHI total 24 (10-26) 22 (10-32) 12 (0-30) 62 (26-84) 14 (0-26) a 16 (0-24) a 14 (0-28) 38 (2-72) a 5 weeks Control Group (n=7) 9 weeks 13 weeks p* Baseline 1 week 5 weeks 9 weeks 13 weeks p* 4 (0-5) a 2 (0-3) a b 0 (0-2) a b c >0.001 8 (5-10) 3 (2-5) a 3 (2-5) a 3 (0-5) a 1 (0-4) a 0.003 10 (0-14) a b 4 (2-18) a b 8 (0-26) a 12 (4-58) a b 4 (0-10) a b 0 (0-8) a b 0 (0-22) a b c 8 (0-40) a b c 0 (0-8) a b 0 (0-6) a b c 0 (0-14) a b 8 (0-18) a b c >0.001 >0.001 0.001 >0.001 16 (12-24) 18 (4-30) 10 (2-16) 40 (22-70) 6 (0-14) a 4 (0-16) a 2 (0-10) a 12 (0-38) a 6 (0-12) a 6 (0-12) a 4 (0-10) 16 (0-32) a 6 (0-10) a 8 (0-20) a 4 (0-12)a 20 (8-42) a 2 (0-10) a 4 (2-14) a 2 (0-4) ad 10 (4-24) a 0.007 0.006 0.006 0.003 † Significant difference between groups a Significant difference within group compared to baseline, p<0.05 b Significant difference within group compared to 1-week, p<0.05 c Significant difference within group compared to 5 weeks, p<0.05 d significant difference within group compared to 9 weeks, p<0.05 * Intragroup comparison VAS, Visual Analogue Scale; DHI, Dizziness Handicap Inventory. 95 6. COMENTÁRIOS, CRÍTICAS E CONCLUSÕES Um problema enfrentado durante a realização deste estudo foi a dificuldade em receber um número maior de encaminhamentos dos idosos com VPPB, contrapondo-se com a literatura a qual demonstra existir uma alta prevalência dessa enfermidade na população em questão. Para otimizar o recebimento dos encaminhamentos, decidimos não aguardar apenas a demanda atendida no ambulatório especializado de Otoneurologia do HUOL e fizemos uma ampla divulgação, e de forma periódica, entre os médicos das principais especialidades que atendessem pacientes com queixas de tontura, vertigem ou desequilíbrio corporal (Otorrinolaringologistas, Geriatras e Neurologistas), tanto no serviço público quanto no privado, sob a forma de contato telefônico e/ou envio de uma carta de esclarecimento acerca da pesquisa por e-mail. (Apêndice 02). Além do baixo número reduzido de encaminhamentos ter impactado diretamente no baixo tamanho da amostra estudada, também uma quantidade significativa de pacientes foi excluída do estudo no processo de triagem para adequação dos critérios de inclusão e exclusão, como por exemplo: Muitos Otorrinolaringologistas não têm por rotina realizarem o teste diagnóstico de Dix-Hallpike em sua prática clínica, por exemplo, por falta de maca nos consultórios, o que justifica o fato de termos aceitado encaminhamentos dos pacientes com suspeita diagnóstica de VPPB. Dessa forma, apesar de termos avaliado e contra referenciado vários pacientes, ao final só obtivemos 16 pacientes elegíveis. Dentre os pacientes excluídos, o que nos chamou à atenção foi o número de indivíduos com teste de DixHallpike negativo, ou em uso de benzodiazepínicos há longa data ou possíveis lesões centrais associadas (esse dois últimos, claras variáveis de confusão para o desfecho). De acordo com Whitney & Herdman (2007) (92) os sinais e sintomas de lesão do sistema nervoso central, os quais podem ser reconhecidos na avaliação funcional, devem ser referenciados ao médico, e alertam sobre possibilidade dos pacientes terem sido encaminhados à RV com lesões não diagnosticadas no Sistema Nervoso Central (SNC). Os autores intitulam alguns sinais e sintomas como “bandeiras vermelhas” na RV (descoordenação, tremores, perda auditiva progressiva, sinais de lesão do neurônio motor superior, disfunção dos nervos cranianos, déficit de memória, dentre outros). Outro fator importante para elencar é o fato de haver apenas um serviço na rede pública especializado em Otoneurologia em nosso Estado e poucos especialistas na rede privada. Com isso, os pacientes enfrentam dificuldade na marcação para o 96 especialista o que indiretamente diminuiu as possibilidades de encaminhamento à Reabilitação Vestibular por meio da pesquisa. Além disso, as equipes e profissionais de Saúde em nossa realidade ainda não são habituados a realizarem ensaios clínicos, o que dificultou muitas vezes a referência e o agendamento para a pesquisa. Outra dificuldade para a realização do estudo é o problema de falta de estrutura e organização da saúde pública do Estado do Rio Grande do Norte (RN), especialmente na rede básica de atendimento, e a falta de treinamento dos profissionais da saúde para lidarem com pacientes idosos portadores de tontura, os quais apresentam doenças associadas e uso crônico de medicações. A tontura é de causa multifatorial, então uma limitação no tratamento tem sido a falta de um serviço clínico integrado em nosso meio. Dependíamos do encaminhamento do médico, uma vez que esse era o profissional habilitado a diagnosticar e solicitar os exames médicos complementares necessários para exclusão de outros fatores de confusão que pudessem interferir nos resultados da pesquisa, como por exemplo, a descompensação metabólica. Uma motivação para o grupo em realizar a pesquisa com idosos portadores de VPPB é que, por ser uma patologia com diagnóstico predominantemente clínico, o recrutamento de pacientes teoricamente seria facilitado, pois não dependeria de exames complementares para finalização diagnóstica. Esses são de difícil e demorado acesso no serviço público, e no serviço privado às vezes há restrições impostas pelos planos de saúde. Não houve nenhum encaminhamento de pacientes com acometimento nem de canal lateral ou anterior, o que condiz com a literatura que aponta a VPPB com lesão de canal posterior ter prevalência de aproximadamente 90% (27, 28, 94). Também tivemos um número mais expressivo de mulheres no estudo o que também é corroborado por outros estudos (23, 34, 94). No nosso planejamento inicial, ao concluírem as treze semanas do protocolo de tratamento, os pacientes de ambos os grupos deveriam ser encaminhados para realização de atividade física direcionada à saúde do idoso com o objetivo de manter ou aprimorar a terapêutica instituída. Porém, nos deparamos com a grande dificuldade nesse tipo de encaminhamento por praticamente não haver na rede pública essa opção. Os idosos contam apenas com as academias “de rua” as quais eles realizam os exercícios físicos por conta própria sem nenhuma orientação especializada (o que aumenta as chances de lesão osteomioarticulares), e realização de caminhadas (muitas vezes em bairros onde não há calçamento adequado, para tal). 97 Por outro lado, podemos elencar vários pontos positivos a partir da realização desta pesquisa: Como não havia serviço público em nenhuma área da reabilitação (sejam elas fisioterapia ou fonoaudiologia) que atendessem a demanda dos pacientes vestibulopatas, decidimos credenciar um projeto de extensão na UFRN nos propondo a atender pacientes de diferentes faixas etárias e tipos de desordens vestibulares, no intuito de divulgar a Reabilitação Vestibular aos médicos do Serviço Público e consequentemente direcionar pacientes para a nossa pesquisa. Realizamos por dois anos este atendimento, o qual, além do escopo da extensão universitária pela assistência à população, propiciou ensino aos alunos integrantes do curso de Fisioterapia (pois eles não tinham até então acesso a essas técnicas) e gerou pesquisa pela realização de trabalhos de conclusão de curso e apresentação de diversos trabalhos em eventos científicos. Observou-se uma ótima adesão dos pacientes de ambos os grupos ao tratamento. Apesar de toda a dificuldade de locomoção por dependerem de transporte público, e muitas vezes de um familiar para acompanhá-los, só nos deparamos com 2 casos de abandono do tratamento. Essa boa adesão pode ser justificada tanto pela melhora em termos “qualitativos” (e com isso eles sentiam-se mais motivados a continuar), quanto pela oportunidade da realização da Reabilitação Vestibular que, em nossa realidade, era inexistente na rede pública e escassa na rede privada. A presente pesquisa também atendeu ao caráter inter e multidisciplinar preconizado pelo Programa de Pós de Pós-Graduação em Ciências da Saúde da UFRN (PPGCSA). Por exemplo, por intermédio desse estudo tive a oportunidade de trabalhar em parceria científica com a médica Lidiane Ferreira, atualmente doutoranda do Programa de Pós-Graduação em Saúde Coletiva na UFRN, na avaliação clínica e funcional de idosos Vestibulopatas, tanto institucionalizados quanto na comunidade da cidade do Natal/ RN, sob a orientação do professor Kenio Costa de Lima. Esta parceria também rendeu apresentações de trabalhos em congressos científicos, orientação de trabalhos de Iniciação Científica e publicações em periódicos. O presente estudo também levou ao início de uma nova linha de pesquisa no Departamento de Fisioterapia e uma estreita cooperação entre esse e o Departamento de Cirurgia da UFRN (por intermédio do Prof. Dr. José Diniz e da Profa. Dra. Luciana Fontes Cunha Lima, ambos do ambulatório de Otoneurologia do HUOL). Como “fruto” dessa pesquisa, tivemos o pioneirismo da UFRN no atendimento na área de Reabilitação Otoneurológica 98 (Vestibular) pelo Sistema Único de Saúde (SUS) no Estado do Rio Grande do Norte. Outro ponto positivo a partir da pesquisa foi a cooperação da Dra. Susan Whitney, referência mundial na área de RV, da University of Pittsburgh (Pittsburgh/PE-EUA) a qual auxiliou em todo o desenho metodológico do estudo. Além da contribuição em minha trajetória como pesquisadora obtive também um enorme aprendizado para a minha vida profissional, pois realizei um amplo treinamento na área da Reabilitação Vestibular em instituições internacionais, sempre encorajada pelo meu orientador. Na Universidade of Pittsburgh realizei os cursos básico (2011) e avançado (2012) em RV além de estágios observacionais. O acompanhamento dos protocolos clínicos realizados pela equipe de Pittsburgh norteou-me bastante na condução do protocolo de avaliação e tratamento da pesquisa. Participei de outro curso em Chicago/IL (2012) coordenado pelo médico Dr. Timothy Hain e pela fisioterapeuta Dra. Janet Helminsk associado ao estágio observacional no Chicago Dizziness Balance and Hearing Center, também centro de referência mundial na área. Para maior acurácia no uso do equipamento Balance Master® realizei um treinamento, por meio do Clinical Integration Seminar, na sede do fabricante – Neurocom em Portland/OR nos EUA. Na ocasião, recebi treinamento em todas as ferramentas de avaliação deste fabricante, as quais são voltadas à avaliação do equilíbrio postural nas mais diferentes populações. Como contrapartida, realizamos um curso de extensão para todos os professores e alunos da graduação e Pós-Graduação envolvidos em pesquisas no curso de Fisioterapia intitulado: “Avaliação do equilíbrio postural com o Balance Master System®”. Atualmente, o Grupo de Epidemiologia do Envelhecimento e Fisioterapia Geriátrica (GEEFG-UFRN), do qual faço parte e é coordenado pelo meu orientador, possui cooperação com o Département de Médecine Sociale et préventive - Université de Montreal, no Canadá. A parceria entre esses grupos foi iniciada em 2006, e desde então vem produzindo trabalhos científicos publicados em revistas de impacto internacional, assim como visitas técnicas de professores da UFRN a instituições canadenses, estágios de Doutorado Sanduiche de alunos do PPGCSA, assim como a vinda de professores canadenses visitantes com o fomento do CNPQ. Visando ampliar as atividades de inserção internacional do PPGCSA-UFRN e do Programa de Pós-Graduação em Fisioterapia da UFRN (PPGFIS), tão necessária para a contribuição na elevação do conceito desses programas junto à CAPES, tive a feliz oportunidade de realizar um doutorado sanduiche no Canadá, na Queen’s University em 99 2013, na cidade de Kingston/ON, sob a orientação no exterior da Profa. Dra. Nandini Deshpande. Seu foco de pesquisa é o impacto das mudanças nas funções sensoriais e na integração sensorial (dos sistemas vestibular, somatossensorial e visual) na mobilidade de idosos. Durante um período de 3 meses nessa instituição tive acesso a novos instrumentos de avaliação para os déficits sensoriais, participei diretamente de um estudo sobre os problemas sensoriais em idosos diabéticos, apresentei seminários na área de Reabilitação Vestibular para os demais estudantes do programa de pósgraduação, vivenciei a troca de saberes com outros alunos inclusive de outras nacionalidades, realizei a análise dos meus dados, além de ter aprimorado meus conhecimentos na língua Inglesa. A oportunidade da realização deste doutorado foi determinante para o meu crescimento como pesquisadora, meu aprimoramento como profissional fisioterapeuta, e para meu amadurecimento pessoal por ter conseguido lidar com as adversidades encontradas ao longo dessa jornada. Por fim, no tocante aos resultados obtidos nesta tese, podemos concluir que a TRV adicional não influenciou na conversão do teste de Dix-Hallpike de positivo para negativo, na recorrência da VPPB, no número de manobras para a negativação do teste de Dix-Hallpike, na redução da sintomatologia da tontura e na melhora da qualidade de vida dos idosos com VPPB crônica. Ambos os grupos apresentaram redução significativa dos sintomas de tontura, o que impactou na melhora da qualidade de vida. Porém, a TRV associada às Manobras de Reposicionamento Canalítico trouxeram benefícios importantes no reestabelecimento do equilíbrio dinâmico desses pacientes. Em termos práticos, os idosos podem beneficiar-se dessa terapia para obterem um melhor desempenho na realização de suas atividades da vida diária, com maior segurança e autonomia, o que pode ser um fator decisivo para evitar quedas, as quais trazem consequências desastrosas na vida dos idoso. 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J Clin Neurol. 2010;6(2):51-63. 105 APENDICES APENDICE 01 APENDICE 02 UNIVERSIDADE FEDERAL DO RIO GRANDE DO NORTE CENTRO DE CIÊNCIAS DA SAÚDE DEPARTAMENTO DE FISIOTERAPIA PROTOCOLO DE AVALIAÇÃO I. IDENTIFICAÇÃO DATA DA AVALIAÇÃO: ENTREVISTADOR: AVALIAÇÃO Nº NOME COMPLETO: ID DO PARTICIPANTE: ENDEREÇO TELEFONE: COMPLETO: IDADE: DATA DE NASC.: SEXO: SEGUIMENTO RG OCUPAÇÃO: HUOL: COR: IMC kg/m2 Solteiro (nunca casou) ( ) Casado/relação estável ( ) QUAL SEU ESTADO CIVIL? Viúvo(a) ( ) Separado/divorciado ( ) Outro ( ) Analfabeto ( ) Primário incompleto( ) Primário completo( ) Secundário incompleto ( ) QUAL O MAIOR NÍVEL DE Secundário completo( ) ESCOLARIDADE VOCÊ TEM? Nível técnico( ) Nível superior incompleto( ) Especialista( ) Mestrado/doutorado( ) Sem resposta ( ) INTERCORRÊNCIAS II. DADOS OTONEUROLÓGICOS DIAGNÓSTICO CLÍNICO: QUEIXA PRINCIPAL: Rotatória ( ) ( ) objetos giram ( ) sente que gira A TONTURA É? ( ) não se aplica Flutuante ( ) Espontânea ( ) Pré-síncope Induzida pelo movimento da cabeça ou do corpo ( ) SINTOMAS NEUROVEGETATIVOS ZUMBIDO QUAL A DURAÇÃO DAS CRISES? Sim ( ) Não ( ) Segundos ( ) 1 – 2 minutos ( ) 1 – 2 horas ( ) >12 horas ( ) Dias ( ) Contínua ( ) Ausente ( ) Diariamente ( ) Semanalmente ( ) FREQUÊNCIA DA TONTURA Mensalmente ( ) Quinzenalmente ( ) Sem tontura ( ) TIPO DA VPPB ( ) Primária ( ) Secundária HÁ QUANTO TEMPO SENTE TONTURA? TEXTE DE DIX-HALLPIKE ( ) Positivo ( ) Negativo Direito ( ) QUAL O LADO DA MANOBRA? Esquerdo ( ) Nenhum ( ) PRESENÇA DE NISTAGMO? Sim ( ) Não ( ) Não realizou manobra ( ) REALIZOU MANOBRA DE EPLEY? Realizou uma manobra ( ) Realizou duas manobras ( ) Realizou três manobras ( ) Escala Visual Analógica da Tontura (EVA) – “Agora você irá dar uma nota para a sua tontura de 0 a 10, sendo 0 (ZERO) sem tontura e 10 (dez) a pior tontura imaginável” 0___________________________________________________________________10 Ausência de tontura Pior tontura imaginável III - DADOS CLÍNICO-FUNCIONAIS DOENÇAS ASSOCIADAS MEDICAMENTOS EM USO: REALIZA EXERCÍCIO FÍSICO? Sim ( ) Não ( ) 1() 2() 3() QUANTAS VEZES NA SEMANA FAZ EXERCÍCIO 4() FÍSICO ? 5() 6() 7() Não se aplica ( ) USA DISPOSITIVOS AUXILIARES PARA MARCHA? QUAL DISPOSITIVO? Sim ( ) Não ( ) APENDICE 03 Caros (as) Otorrinolaringologistas, Sou Fisioterapeuta, doutoranda em Ciências da Saúde pela UFRN e estou realizando a pesquisa: Avaliação da Reabilitação Vestibular em idosos com Vertigem Postural Paroxística Benigna (VPPB), conjunta entre o Departamento de Fisioterapia e o Setor de Otorrinolaringologia da UFRN, sob a orientação do Prof. Dr. Ricardo Guerra e colaboração da Profa. Dra. Luciana Fontes da Cunha Lima e Prof. Dr. José Diniz Júnior. Solicitamos encaminhamento de indivíduos que tenham: - Diagnóstico clínico de vertigem postural paroxística benigna (VPPB) com manobra de Dix-Hallpike positiva para um ou ambos os lados e idade ≥ 65 anos; Como critérios de exclusão para o atendimento temos: Doenças sistêmicas descompensadas e/ou sem controle medicamentoso; Restrição motora, cognitiva e/ou visual que impeça a realização adequada da avaliação laboratorial do equilíbrio e dos exercícios de Reabilitação Vestibular; Realização prévia de manobras de reposicionamento canalítico e/ou protocolos de exercícios para treino do equilíbrio postural. Os pacientes serão submetidos a uma avaliação computadorizada do equilíbrio postural e a manobras de reposicionamento canalítico guiada por videonistagmoscopia. A reabilitação que os pacientes receberão será de acordo com a distribuição nos grupos experimental e controle da investigação. Agradecemos desde já a colaboração. Agendamento: Setor de Fisioterapia do HUOL- 2o subsolo Fones: 3342-5014 / 8817-6434 Karyna Figueiredo Ribeiro Fisioterapeuta Estou à disposição para maiores esclarecimentos. Fone 99867237 (celular pessoal) [email protected] ANEXOS ANEXO 01 VERSÃO BRASILEIRA DO DIZZINESS HANDICAP INVENTORY ITEM 1 FI Olhar para cima piora sua tontura? Sim Não Às vezes 2 EM Você se sente frustrado (a) divido à sua tontura? Sim Não Às vezes 3 FU Você restringe suas viagens de trabalho ou lazer por causa da tontura? Sim Não Às vezes 4 FI Andar pelo corredor de um supermercado piora sua tontura? Sim Não Às vezes 5 FU Devido à sua tontura, você tem dificuldade ao deitar-se ou levantar-se da Sim Não Às vezes cama? 6 FU Sua tontura restringe significativamente sua participação em atividades Sim Não Às vezes sociais tais como: sair para jantar, ir ao cinema, dançar ou ir a festas? 7 FU Devido à sua tontura, você tem dificuldade para ler? Sim Não Às vezes 8 FI Sua tontura piora quando você realiza atividades mais difíceis como Sim Não Às vezes esportes, dançar, trabalhar em atividades domésticas tais como: varrer e guardar a louça? 9 EM Devido à sua tontura, você tem medo de sair de casa sem ter alguém que o Sim Não Às vezes acompanhe? 10 EM Devido à sua tontura, você se sente envergonhado na presença de outras Sim Não Às vezes 11 FI Movimentos rápidos da sua cabeça pioram a sua tontura? Sim Não Às vezes 12 FU Devido à sua tontura, você evita lugares altos? Sim Não Às vezes 13 FI Virar-se na cama piora sua tontura? Sim Não Às vezes 14 FU Devido à sua tontura é difícil para você realizar trabalhos domésticos Sim Não Às vezes 15 EM Por causa da sua tontura, você teme que as pessoas achem que você está 16 FU Devido a sua tontura é difícil para você sair para caminhar sem ajuda? Sim Não Às vezes 17 FI Caminhar na calçada piora a sua tontura? Sim Não Às vezes 18 EM Devido à sua tontura, é difícil para você se concentrar? Sim Não Às vezes 19 FU Devido à sua tontura, é difícil para você andar pela casa no escuro? Sim Não Às vezes 20 EM Devido à sua tontura, você tem medo de ficar em casa sozinho? Sim Não Às vezes 21 EM Devido à sua tontura, você se sente incapacitado? Sim Não Às vezes 22 EM Sua tontura prejudica suas relações com membros de sua família ou Sim Não Às vezes pessoas? pesados ou cuidar do quintal? Sim Não Às vezes drogado (a) ou bêbado (a)? amigos? 23 EM Devido à sua tontura, você está deprimido? Sim Não Às vezes 24 FU Sua tontura interfere em seu trabalho ou responsabilidades em casa? Sim Não Às vezes 25 FI Inclinar-se piora sua tontura? Sim Não Às vezes Legenda: FI- aspectos físicos/ FU- aspectos funcionais/ EM- aspectos emocionais Pontuação: a cada resposta: sim= 4 pontos; às vezes= 2 pontos; não= 0 pontos. Castro ASO, Gazzola JM, Natour J, Ganança FF.Versão brasileira do Dizziness Handicap Inventory. PróFono Revista de Atualização Científica. 2007; 19 (1): 97-104. ANEXO 02 VERSÃO BRASILEIRA DO DYNAMIC GAIT INDEX DGI - VERSÃO BRASILEIRA 1- Marcha em superfície plana___ Instruções: Ande em sua velocidade normal, daqui até a próxima marca (6 metros). Classificação: Marque a menor categoria que se aplica (3) Normal: Anda 6 metros, sem dispositivos de auxílio, em boa velocidade, sem evidência de desequilíbrio, marcha em padrão normal. (2) Comprometimento leve: Anda 6 metros, velocidade lenta, marcha com mínimos desvios, ou utiliza dispositivos de auxílio à marcha. (1) Comprometimento moderado: Anda 6 metros, velocidade lenta, marcha em padrão anormal, evidência de desequilíbrio. (0) Comprometimento grave: Não conseguem andar 6 metros sem auxílio, grandes desvios da marcha ou desequilíbrio. 2. Mudança de velocidade da marcha____ Instruções: Comece andando no seu passo normal (1,5 metros), quando eu falar “rápido”, ande o mais rápido que você puder (1,5 metros). Quando eu falar “devagar”, ande o mais devagar que você puder (1,5 metros). Classificação: Marque a menor categoria que se aplica (3) Normal: É capaz de alterar a velocidade da marcha sem perda de equilíbrio ou desvios. Mostra diferença significativa na marcha entre as velocidades normal, rápido e devagar. (2) Comprometimento leve: É capaz de mudar de velocidade mas apresenta discretos desvios da marcha, ou não tem desvios mas não consegue mudar significativamente a velocidade da marcha, ou utiliza um dispositivo de auxílio à marcha. (1) Comprometimento moderado: Só realiza pequenos ajustes na velocidade da marcha, ou consegue mudar a velocidade com importantes desvios na marcha, ou muda de velocidade e perde o equilíbrio, mas consegue recuperá-lo e continuar andando. (0) Comprometimento grave: Não consegue mudar de velocidade, ou perde o equilíbrio e procura apoio na parede, ou necessita ser amparado 3. Marcha com movimentos horizontais (rotação) da cabeça____ Instruções: Comece andando no seu passo normal. Quando eu disser “olhe para a direita”, vire a cabeça para o lado direito e continue andando para frente até que eu diga “olhe para a esquerda”, então vire a cabeça para o lado esquerdo e continue andando. Quando eu disser “olhe para frente”, continue andando e volte a olhar para frente. Classificação: Marque a menor categoria que se aplica (3) Normal: Realiza as rotações da cabeça suavemente, sem alteração da marcha. (2) Comprometimento leve: Realiza as rotações da cabeça suavemente, com leve alteração da velocidade da marcha, ou seja, com mínima alteração da progressão da marcha, ou utiliza dispositivo de auxílio à marcha. (1) Comprometimento moderado: Realiza as rotações da cabeça com moderada alteração da velocidade da marcha, diminui a velocidade, ou cambaleia mas se recupera e consegue continuar a andar. (0) Comprometimento grave: Realiza a tarefa com grave distúrbio da marcha, ou seja, cambaleando para fora do trajeto (cerca de 38cm), perde o equilíbrio, pára, procura apoio na parede, ou precisa ser amparado. 4. Marcha com movimentos verticais (rotação) da cabeça ____ Instruções: Comece andando no seu passo normal. Quando eu disser “olhe para cima”, levante a cabeça e olhe para cima. Continue andando para frente até que eu diga “olhe para baixo” então incline a cabeça para baixo e continue andando. Quando eu disser “olhe para frente”, continue andando e volte a olhar para frente. Classificação: Marque a menor categoria que se aplica (3) Normal: Realiza as rotações da cabeça sem alteração da marcha. (2) Comprometimento leve: Realiza a tarefa com leve alteração da velocidade da marcha, ou seja, com mínima alteração da progressão da marcha, ou utiliza dispositivo de auxílio à marcha. (1) Comprometimento moderado: Realiza a tarefa com moderada alteração da velocidade da marcha, diminui a velocidade, ou cambaleia mas se recupera e consegue continuar a andar. (0) Comprometimento grave: Realiza a tarefa com grave distúrbio da marcha, ou seja, cambaleando para fora do trajeto (cerca de 38cm), perde o equilíbrio, pára, procura apoio na parede, ou precisa ser amparado. 5. Marcha e giro sobre o próprio eixo corporal (pivô)____ Instruções: Comece andando no seu passo normal. Quando eu disser “vire-se e pare”, vire-se o mais rápido que puder para a direção oposta e permaneça parado de frente para (este ponto) seu ponto de partida”. Classificação: Marque a menor categoria que se aplica (3) Normal: Gira o corpo com segurança em até 3 segundos e pára rapidamente sem perder o equilíbrio. (2) Comprometimento leve: Gira o corpo com segurança em um tempo maior que 3 segundos e pára sem perder o equilíbrio. (1) Comprometimento moderado: Gira lentamente, precisa dar vários passos pequenos até recuperar o equilíbrio após girar o corpo e parar, ou precisa de dicas verbais. (0) Comprometimento grave: Não consegue girar o corpo com segurança, perde o equilíbrio, precisa de ajuda para virar-se e parar. 6. Passar por cima de obstáculo____ Instruções: Comece andando em sua velocidade normal. Quando chegar à caixa de sapatos, passe por cima dela, não a contorne, e continue andando. Classificação: Marque a menor pontuação que se aplica (3) Normal: É capaz de passar por cima da caixa sem alterar a velocidade da marcha, não há evidência de desequilíbrio. (2) Comprometimento leve: É capaz de passar por cima da caixa, mas precisa diminuir a velocidade da marcha e ajustar os passos para conseguir ultrapassar a caixa com segurança. (1) Comprometimento moderado: É capaz de passar por cima da caixa, mas precisa parar e depois transpor o obstáculo. Pode precisar de dicas verbais. (0) Comprometimento grave: Não consegue realizar a tarefa sem ajuda. 7. Contornar obstáculos___ Instruções: Comece andando na sua velocidade normal e contorne os cones. Quando chegar no primeiro cone (cerca de 1,8 metros), contorne-o pela direita, continue andando e passe pelo meio deles, ao chegar no segundo cone (cerca de 1.8 m depois do primeiro), contorne-o pela esquerda. Classificação: Marque a menor categoria que se aplica (3) Normal: É capaz de contornar os cones com segurança, sem alteração da velocidade da marcha. Não há evidência de desequilíbrio. (2) Comprometimento leve: É capaz de contornar ambos os cones, mas precisa diminuir o ritmo da marcha e ajustar os passos para não bater nos cones. (1) Comprometimento moderado: É capaz de contornar os cones sem bater neles, mas precisa diminuir significativamente a velocidade da marcha para realizar a tarefa, ou precisa de dicas verbais. (0) Comprometimento grave: É incapaz de contornar os cones; bate em um deles ou em ambos, ou precisa ser amparado. 8. Subir e descer degraus____ Instruções: Suba estas escadas como você faria em sua casa (ou seja, usando o corrimão, se necessário). Quando chegar ao topo, vire-se e desça. Classificação: Marque a menor categoria que se aplica (3) Normal: Alterna os pés, não usa o corrimão. (2) Comprometimento leve: Alterna os pés, mas precisa usar o corrimão. (1) Comprometimento moderado: Coloca os dois pés em cada degrau; precisa usar o corrimão. (0) Comprometimento grave: Não consegue realizar a tarefa com segurança. GANAÇA, FF; Perracini, MR; Castro, SM. Versão Brasileira do Dynamic Gait Index. Revista Brasileira de Otorrinolaringologia, 2006. 72 (6):817-25.