Improvement of gait and balance function in chronic post-stroke patients induced by Lower Extremity - Constraint Induced Movement Therapy: a randomized controlled clinical trial.

OBJECTIVE: To evaluate the effects of Lower Extremity - Constraint Induced Movement Therapy on gait function and balance in chronic hemiparetic patients. METHODS: Randomized, controlled, single-blinded study. We recruited chronic post stroke patients and allocated them to Lower Extremity - Constraint Induced Movement Tharapy (LE-CIMT) or Control Group. The LE-CIMT group received this protocol 2.5 hour/day for 15 followed days, including: 1) intensive supervised training, 2) use of shaping as a strategy for motor training, and 3) application of a transfer package. The control group received conventional physiotherapy for 2.5 hours/day for 15 followed days. Outcomes were assessed at baseline, after the interventions, and after 6 months, through 6-minute walk test and Mini-Balance Evaluation Systems Test; 10-meter walk test, Timed Up and Go, 3-D gait analysis, and Lower Extremity - Motor Activity Log. RESULTS: LE-CIMT was superior on the Assistance and confidence subscale of Lower Extremity - Motor Activity Log, Mini-BESTest and 6-minute walk test. The effect size for all outcomes was small when comparing both groups. LE-CIMT showed clinically significant differences in daily activities, balance, and gait capacity, with no clinically significant difference for spatiotemporal parameters. CONCLUSION: The LE-CIMT protocol had positive outcomes on balance, performance, and confidence perception.

Measurement properties of the Brazilian Portuguese version of the Lower-Extremity Motor Activity Log for chronic hemiparetic poststroke patients.

BACKGROUND: Stroke is among the three leading causes of disability around the world, and it results in immediate difficulty in mobility and gait. There is a lack of instruments to evaluate what daily life is like for these individuals using their lower limbs in real-life environments (outside of the clinical environment). OBJECTIVE: To perform the translation and cultural adaptation to Brazilian Portuguese of the Lower-Extremity Motor Activity Log (LE-MAL) and test its measurement properties in chronic poststroke individuals. METHODS: The LE-MAL was translated into Brazilian Portuguese and adapted to the Brazilian culture. The comprehension and relevance of the final version were analyzed by a committee of specialists. The reliability, validity, and responsiveness of the LE-MAL/Brazil to detect changes after lower extremity constraint-induced movement therapy (LE-CIMT) and an intensive conventional therapy were tested. RESULTS: The LE-MAL/Brazil showed excellent inter- and intrarater reliability, with an intraclass correlation coefficient and Cronbach alpha > 0.70, as well as standard error of measurement and smallest detectable change < 10% of the total instrument score when applied by the same evaluators. CONCLUSION: The responsiveness of the LE-MAL/Brazil to detect changes showed better results after LE-CIMT than after the intensive conventional therapy, with most of the correlations > 0.50.

ANTECEDENTES: O acidente vascular cerebral (AVC) é a terceira causa de deficiência ao redor do mundo, e resulta em dificuldades imediatas relativas à marcha e à mobilidade. Nota-se a ausência de instrumentos que avaliem o dia a dia desses indivíduos quanto ao uso dos membros inferiores em ambientes reais (fora do ambiente clínico). OBJETIVO: Traduzir e fazer a adaptação cultural para o português do Brasil da Lower-Extremity Motor Activity Log (LE-MAL), e testar suas propriedades psicométricas em indivíduos hemiparéticos crônicos pós-AVC. MéTODOS: A LE-MAL foi traduzida para o português do Brasil e adaptada para a cultura brasileira. A compreensão e a confiabilidade da versão final foram testadas por um comitê de especialistas. A confiabilidade, a validade e a responsividade em detectar mudanças após a terapia de contensão induzida para membros inferiores (TCI-MMII) e uma terapia convencional também foram testadas. RESULTADOS: A LE-MAL/Brazil mostrou excelente confiabilidade intra e interavaliador, com coeficiente de correlação intraclasse e alfa de Cronbach > 0,70, bem como erro padrão da medida e mínima mudança detectável < 10% da pontuação total quando aplicada pelo mesmo avaliador. CONCLUSãO: A responsividade da LE-MAL/Brazil em detectar mudanças após a TCI-MMII apresentou resultados melhores do que após a terapia convencional, com a maioria das correlações > 0,50.

Measurement properties of the Brazilian Portuguese version of the Lower-Extremity Motor Activity Log for chronic hemiparetic poststroke patients / Propriedades de medida da versão brasileira da Lower-Extremity Motor Activity Log para pacientes hemiparéticos crônicos pós-AVC

Abstract Background Stroke is among the three leading causes of disability around the world, and it results in immediate difficulty in mobility and gait. There is a lack of instruments to evaluate what daily life is like for these individuals using their lower limbs in real-life environments (outside of the clinical environment). Objective To perform the translation and cultural adaptation to Brazilian Portuguese of the Lower-Extremity Motor Activity Log (LE-MAL) and test its measurement properties in chronic poststroke individuals. Methods The LE-MAL was translated into Brazilian Portuguese and adapted to the Brazilian culture. The comprehension and relevance of the final version were analyzed by a committee of specialists. The reliability, validity, and responsiveness of the LE-MAL/Brazil to detect changes after lower extremity constraint-induced movement therapy (LE-CIMT) and an intensive conventional therapy were tested. Results The LE-MAL/Brazil showed excellent inter- and intrarater reliability, with an intraclass correlation coefficient and Cronbach alpha > 0.70, as well as standard error of measurement and smallest detectable change < 10% of the total instrument score when applied by the same evaluators. Conclusion The responsiveness of the LE-MAL/Brazil to detect changes showed better results after LE-CIMT than after the intensive conventional therapy, with most of the correlations > 0.50.

Resumo Antecedentes O acidente vascular cerebral (AVC) é a terceira causa de deficiência ao redor do mundo, e resulta em dificuldades imediatas relativas à marcha e à mobilidade. Nota-se a ausência de instrumentos que avaliem o dia a dia desses indivíduos quanto ao uso dos membros inferiores em ambientes reais (fora do ambiente clínico). Objetivo Traduzir e fazer a adaptação cultural para o português do Brasil da Lower-Extremity Motor Activity Log (LE-MAL), e testar suas propriedades psicométricas em indivíduos hemiparéticos crônicos pós-AVC. Métodos A LE-MAL foi traduzida para o português do Brasil e adaptada para a cultura brasileira. A compreensão e a confiabilidade da versão final foram testadas por um comitê de especialistas. A confiabilidade, a validade e a responsividade em detectar mudanças após a terapia de contensão induzida para membros inferiores (TCI-MMII) e uma terapia convencional também foram testadas. Resultados A LE-MAL/Brazil mostrou excelente confiabilidade intra e interavaliador, com coeficiente de correlação intraclasse e alfa de Cronbach > 0,70, bem como erro padrão da medida e mínima mudança detectável < 10% da pontuação total quando aplicada pelo mesmo avaliador. Conclusão A responsividade da LE-MAL/Brazil em detectar mudanças após a TCI-MMII apresentou resultados melhores do que após a terapia convencional, com a maioria das correlações > 0,50.

Effects of lower extremity constraint-induced movement therapy on gait and balance of chronic hemiparetic patients after stroke: description of a study protocol for a randomized controlled clinical trial.

BACKGROUND: Protocols involving intensive practice have shown positive outcomes. Constraint induced movement therapy (CIT) appears to be one of the best options for better outcomes in upper limb rehabilitation, but we still have little data about lower extremity constraint-induced movement therapy (LE-CIT) and its effects on gait and balance. OBJECTIVE: To evaluate the effects of an LE-CIT protocol on gait functionality and balance in chronic hemiparetic patients following a stroke. METHODS: The study adopts a randomized, controlled, single-blinded study design. Forty-two patients, who suffered a stroke, who were in the chronic phase of recovery (>6 months), with gait disability (no community gait), and who were able to walk at least 10 m with or without the advice or support of 1 person, will be randomly allocated to 2 groups: the LE-CIT group or the control group (intensive conventional therapy). People will be excluded if they have speech deficits that render them unable to understand and/or answer properly to evaluation scales and exercises selected for the protocol and/or if they have suffered any clinical event between the screening and the beginning of the protocol. Outcome will be assessed at baseline (T0), immediately after the intervention (T1), and after 6 months (T2). The outcome measures chosen for this trial are as follows: 6-min walk test (6minWT), 10-m walk test (10mWT), timed up and go (TUG), 3-D gait analysis (3DGA), Mini Balance Evaluation Systems Test (Mini-BESTest), and as a secondary measure, Lower Extremity Motor Activity Log will be evaluated (LE-MAL). The participants in both groups will receive 15 consecutive days of daily exercise. The participants in the LE-CIT group will be submitted to this protocol 2.5 h/day for 15 consecutive days. It will include (1) intensive supervised training, (2) use of shaping as strategy for motor training, and (3) application of a transfer package (plus 30 min). The control group will receive conventional physiotherapy for 2.5 h/day over 15 consecutive days (the same period as the CIT intervention). Repeated measures analyses will be made to compare differences and define clinically relevant changes between groups. RESULTS: Data collection is currently on-going and results are expected in 2021. DISCUSSION: LE-CIT seems to be a good protocol for inclusion into stroke survivors' rehabilitation as it has all the components needed for positive results, as well as intensity and transference of gains to daily life activities. TRIAL REGISTRATION: www.ensaiosclinicos.gov.br RBR-467cv6 . Registered on 10 October 2017. "Effects of Lower Extremities - Constraint Induced Therapy on gait and balance function in chronic hemipretic post-stroke patients".