Visual and Auditory Electromyography Biofeedback Among Stroke Patients
14 de julho de 2026 atualizado por: Adnan Hashim, University of Lahore
Comparative Effects of Visual and Auditory Electromyography Biofeedback Combined With Conventional Physiotherapy on Balance, Functional Mobility, Motor Function, and Functional Independence Among Patients With Stroke: A Randomized Controlled Trial
Stroke commonly results in impairments of balance, mobility, and lower extremity motor function that limit independence in daily activities.
Electromyography (EMG) biofeedback enhances motor relearning by providing real-time feedback regarding muscle activation.
Although both visual and auditory EMG biofeedback have demonstrated benefits in stroke rehabilitation, evidence directly comparing these feedback modalities remains limited.
This randomized controlled trial aims to compare the effects of visual and auditory EMG biofeedback, each combined with conventional physiotherapy, on balance, functional mobility, motor function, and functional independence in individuals with stroke.
Visão geral do estudo
Status
Ativo, não recrutando
Condições
Descrição detalhada
This randomized controlled trial will compare two modes of electromyography biofeedback in individuals with stroke undergoing lower extremity rehabilitation.
Eighty-four eligible participants will be randomly allocated into two parallel groups using sealed-envelope randomization.
Both groups will receive conventional physiotherapy consisting of lower extremity strengthening, balance, gait, and task-oriented exercises for 10 minutes per session.
The experimental intervention will consist of either visual or auditory EMG biofeedback applied to the tibialis anterior muscle for 20 minutes.
Treatment will be provided five sessions per week over three weeks (15 sessions).
Outcomes including balance (Berg Balance Scale), functional mobility (Timed Up and Go Test), motor recovery (Fugl-Meyer Assessment-Lower Extremity), and functional independence (Barthel Index) will be assessed at baseline and immediately after completion of the intervention by a blinded assessor.
Tipo de estudo
Intervencional
Inscrição (Estimado)
84
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Multan Khurd, Paquistão
- Nishtar Hospital Multan
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- Age between 20 and 30 years
- Male or female participants
- Clinically diagnosed hemiplegic stroke.
- Medically stable and able to participate in rehabilitation.
- No visual impairment that would interfere with visual biofeedback.
- No hearing impairment that would interfere with auditory biofeedback.
- No sensory aphasia affecting the ability to understand study instructions.
Exclusion Criteria:
- Traumatic injury or lesion affecting the lower extremities
- Lower-limb amputation
- Severe systemic disease that could interfere with participation
- Peripheral vascular disease affecting the lower extremities
- Fixed ankle contracture
- Motion sickness or intolerance to rehabilitation technology
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Visual EMG Biofeedback + Conventional Physiotherapy
Participants assigned to this arm will receive 10 minutes of conventional physiotherapy followed by 20 minutes of visual electromyography (EMG) biofeedback training.
Surface EMG electrodes will be applied to the tibialis anterior muscle of the affected lower extremity.
Real-time visual feedback displayed on a monitor will guide voluntary muscle activation to improve balance, motor recovery, functional mobility, and functional independence.
Treatment will be provided for 30 minutes per session, five sessions per week for three weeks (15 sessions).
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Surface electromyography biofeedback will provide real-time visual feedback of muscle activity from the tibialis anterior muscle using graphical displays on a monitor.
Participants will perform task-oriented lower extremity exercises while observing muscle activation to facilitate motor relearning and improve balance, functional mobility, and lower extremity motor function.
The intervention will be delivered for 20 minutes per session, five sessions per week for three weeks.
Conventional physiotherapy will consist of lower extremity strengthening exercises, task-oriented functional training, balance exercises, gait training, stretching, and mobility exercises.
All participants will receive 10 minutes of conventional physiotherapy before EMG biofeedback during each treatment session.
The intervention will be delivered five sessions per week for three weeks.
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|
Experimental: Auditory EMG Biofeedback + Conventional Physiotherapy
Participants assigned to this arm will receive 10 minutes of conventional physiotherapy followed by 20 minutes of auditory electromyography (EMG) biofeedback training.
Surface EMG electrodes will be applied to the tibialis anterior muscle of the affected lower extremity.
Muscle activation will be translated into real-time auditory cues to facilitate voluntary muscle contraction, motor relearning, and improvement in balance and functional mobility.
Treatment will be provided for 30 minutes per session, five sessions per week for three weeks (15 sessions).
|
Conventional physiotherapy will consist of lower extremity strengthening exercises, task-oriented functional training, balance exercises, gait training, stretching, and mobility exercises.
All participants will receive 10 minutes of conventional physiotherapy before EMG biofeedback during each treatment session.
The intervention will be delivered five sessions per week for three weeks.
Surface electromyography biofeedback will provide real-time auditory feedback corresponding to muscle activation of the tibialis anterior muscle.
Participants will perform task-oriented lower extremity exercises while using auditory cues to facilitate muscle activation, movement coordination, and motor recovery.
The intervention will be delivered for 20 minutes per session, five sessions per week for three weeks.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Balance (Berg Balance Scale)
Prazo: Baseline and Week 3 (Post-intervention)
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Balance will be assessed using the Berg Balance Scale (BBS), a 14-item performance-based measure of static and dynamic balance.
Scores range from 0 to 56, with higher scores indicating better balance performance.
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Baseline and Week 3 (Post-intervention)
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Functional mobility (Timed Up and Go Test)
Prazo: Baseline and Week 3 (Post-intervention)
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Functional mobility will be assessed using the Timed Up and Go (TUG) Test.
The time (seconds) required to stand from a chair, walk 3 meters, turn, return, and sit will be recorded.
Lower completion times indicate better functional mobility.
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Baseline and Week 3 (Post-intervention)
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Motor function (Fugl-Meyer Assessment-Lower Extremity)
Prazo: Baseline and Week 3 (Post-intervention)
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Motor function will be assessed using the Fugl-Meyer Assessment-Lower Extremity (FMA-LE).
The FMA-LE contains 17 items with a total score ranging from 0 to 34.
Higher scores indicate greater motor recovery.
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Baseline and Week 3 (Post-intervention)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Functional independence (Barthel Index)
Prazo: Baseline and Week 3 (Post-intervention)
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Functional independence will be assessed using the Barthel Index (BI).
The BI evaluates independence in activities of daily living, with scores ranging from 0 to 100.
Higher scores indicate greater functional independence.
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Baseline and Week 3 (Post-intervention)
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
9 de abril de 2026
Conclusão Primária (Estimado)
10 de setembro de 2026
Conclusão do estudo (Estimado)
12 de outubro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
14 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
14 de julho de 2026
Primeira postagem (Real)
17 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
17 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
14 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- UOL/IREB/26/19/01/0002
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
Individual participant data will not be shared because this study was conducted as an academic research project.
The informed consent obtained from participants did not include provisions for public data sharing, and the dataset contains sensitive personal health information.
Data will be stored securely and used only for academic and research purposes in accordance with institutional ethics approval.
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Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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