Closed-loop Sensorimotor Integrated (CSMI) Control in Exoneuromusculoskeleton (ENMS) for Precise Wrist-hand Rehabilitation After Stroke
31 de julho de 2026 atualizado por: Xiaoling Hu, The Hong Kong Polytechnic University
The goal of this randomized controlled trial is to determine whether using both brain and muscle signals to control a wrist-hand rehabilitation robot can improve recovery in people with chronic stroke.
A total of 48 participants will be randomly assigned to one of two groups. Both groups will receive 20 sessions of wrist-hand rehabilitation using an exoneuromusculoskeleton rehabilitation robot.
In the closed-loop sensorimotor integrated group, the system will use information from both brain-muscle coordination and muscle activity to recognize the participant's movement intention and provide electrical stimulation and robotic assistance. In the electromyography-driven group, the system will use muscle activity alone to control the electrical stimulation and robotic assistance.
The main questions this study aims to answer are:
Does control using both brain and muscle signals improve wrist and hand motor function more than control using muscle signals alone? Does this approach produce greater changes in coordination between the brain and muscles? Participants will complete motor-function and brain-muscle assessments before training, immediately after the 20 training sessions, and 3 months after training.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
48
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.
Contato de estudo
- Nome: Xiaoling Hu, Phd
- Número de telefone: 852 3400 3206
- E-mail: xiaoling.hu@polyu.edu.hk
Locais de estudo
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Kowloon
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Hung Hom, Kowloon, Hong Kong
- Recrutamento
- The Hong Kong Polytechnic University
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Contato:
- Xiaoling Hu, Phd
- Número de telefone: 852 3400 3206
- E-mail: mailxiaoling.hu@polyu.edu.hk
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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:
- at least 6 months after the onset of a unilateral lesion due to stroke;
- moderate to severe motor disability in the paretic wrist-hand joints (6<Fugl-Meyer Wrist-Hand Assessment (FMAWH)<14) and spasticity in wrist-hand (Modified Ashworth Score (MAS) ≤3);
- sensory impairment on their affected forearm with a score of 1 measured by the sensation part of light touch in the FMA;
- maximal voluntary contraction (MVC) with detectable EMG (3 times of the standard deviation above the resting EMG baseline) in the muscle union of the flexor digitorum and flexor carpi radialis (FD-FCR) and that of the extensor digitorum and extensor carpi ulnaris (ED-ECU);
- sufficient cognition to follow experimental instructions (Mini-Mental State Examination score >21);
- aged from 30 to 70 years.
Exclusion Criteria:
- currently pregnant;
- dysphasia (language deficiency);
- skull implantation;
- post-stroke neglect;
- pacemaker implantation;
- involved in drug studies, other clinical trials, or concurrent medication/occupational/physical treatments on the upper limb;
- the overall medical condition not suitable for the training (e.g., severe cardiac problem, unstable blood pressure, etc.).
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: Closed-Loop Sensorimotor Integrated Group
Participants will receive 20 sessions of wrist-hand rehabilitation using an exoneuromusculoskeleton (ENMS).
In this group, corticomuscular coherence (CMC) and electromyographic (EMG) signals will be used together to identify voluntary movement intention and control neuromuscular electrical stimulation and robotic assistance during wrist and hand movements.
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The exoneuromusculoskeleton (ENMS) provides neuromuscular electrical stimulation and robotic assistance for wrist-hand rehabilitation.
In the CSMI-controlled intervention, corticomuscular coherence and electromyographic signals are jointly used to identify voluntary movement intention and trigger assistance.
Participants will receive 20 training sessions.
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Comparador Ativo: EMG-Driven Group
Participants will receive 20 sessions of wrist-hand rehabilitation using the same exoneuromusculoskeleton (ENMS).
In this group, electromyographic (EMG) activity alone will be used to identify voluntary movement intention and control neuromuscular electrical stimulation and robotic assistance during wrist and hand movements.
|
The exoneuromusculoskeleton (ENMS) provides neuromuscular electrical stimulation and robotic assistance for wrist-hand rehabilitation.
In the EMG-driven intervention, electromyographic activity alone is used to identify voluntary movement intention and trigger assistance.
Participants will receive 20 training sessions.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Fugl-Meyer Assessment Wrist/Hand Subscale (FMA-WH) Score
Prazo: At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training
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The Fugl-Meyer Assessment Wrist and Hand Subscore (FMA-WH) evaluates motor impairment of the paretic wrist and hand after stroke.
The score ranges from 0 to 24, including a maximum of 10 points for wrist function and 14 points for hand function.
Higher scores indicate better wrist-hand motor function.
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At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Finger Spasticity Assessed by the Modified Ashworth Scale (MAS)
Prazo: At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training
|
The Modified Ashworth Scale (MAS) evaluates resistance to passive movement as an indicator of muscle tone and spasticity at the fingers.
Possible grades are 0, 1, 1+, 2, 3, and 4, with a minimum grade of 0 and a maximum grade of 4. Higher grades indicate greater resistance to passive movement and more severe spasticity.
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At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training
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Wrist Spasticity Assessed by the Modified Ashworth Scale (MAS)
Prazo: At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training
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The Modified Ashworth Scale (MAS) evaluates resistance to passive movement as an indicator of muscle tone and spasticity at the fingers.
Possible grades are 0, 1, 1+, 2, 3, and 4, with a minimum grade of 0 and a maximum grade of 4. Higher grades indicate greater resistance to passive movement and more severe spasticity.
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At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training
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Elbow Spasticity Assessed by the Modified Ashworth Scale (MAS)
Prazo: At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training
|
The Modified Ashworth Scale (MAS) evaluates resistance to passive movement as an indicator of muscle tone and spasticity at the fingers.
Possible grades are 0, 1, 1+, 2, 3, and 4, with a minimum grade of 0 and a maximum grade of 4. Higher grades indicate greater resistance to passive movement and more severe spasticity.
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At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training
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Fugl-Meyer Assessment Shoulder/Elbow Subscale Score
Prazo: At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training
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The Fugl-Meyer Assessment Shoulder/Elbow Subscore evaluates proximal upper-extremity motor impairment, including movements of the shoulder, elbow, and forearm.
The score ranges from 0 to 36.
Higher scores indicate better proximal upper-extremity motor function.
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At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training
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Action Research Arm Test (ARAT) Score
Prazo: At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training
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The Action Research Arm Test (ARAT) evaluates upper-extremity activity performance through 19 items covering grasp, grip, pinch, and gross movement.
The total score ranges from 0 to 57.
Higher scores indicate better upper-extremity activity performance.
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At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training
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Outras medidas de resultado
Medida de resultado |
Prazo |
|---|---|
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EMG Co-contraction Index During Wrist-Hand Tasks
Prazo: At the pre-training assessment, immediately after completion of the 20 training sessions, and 3 months after completion of training
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At the pre-training assessment, immediately after completion of the 20 training sessions, and 3 months after completion of training
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Dynamic Neuromuscular Network Functional Connectivity
Prazo: At the pre-training assessment, immediately after completion of the 20 training sessions, and 3 months after completion of training
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At the pre-training assessment, immediately after completion of the 20 training sessions, and 3 months after completion of training
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Peak Beta-Band Corticomuscular Coherence Value
Prazo: At the pre-training assessment, immediately after completion of the 20 training sessions, and 3 months after completion of training
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At the pre-training assessment, immediately after completion of the 20 training sessions, and 3 months after completion of training
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Cortical Location of Peak Beta-Band Corticomuscular Coherence
Prazo: At the pre-training assessment, immediately after completion of the 20 training sessions, and 3 months after completion of training
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At the pre-training assessment, immediately after completion of the 20 training sessions, and 3 months after completion of training
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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)
1 de janeiro de 2025
Conclusão Primária (Estimado)
31 de dezembro de 2027
Conclusão do estudo (Estimado)
31 de dezembro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
27 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
27 de julho de 2026
Primeira postagem (Real)
30 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
3 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
31 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- GRF15218324
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Não
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