Interactive Intention-Driven Upper-Limb Training Robotic System
Trial: Interactive Intention-Driven Upper-Limb Training Robotic System
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This study will investigate the recovery in hand and upper limb functions when the physical training is assisted by an exoskeleton robotic hand system.
Subjects with a pure unilateral motor paresis after a stroke (ischemic or hemorrhagic). All subjects should have sufficient cognition to follow simple instructions as well as understand the content and purpose of the experiment, and also should be able to sit up for 1 hour.
During the training, you will be asked to do the hand open and hand grasp by Electromyography-driven robotic control strategy.
There will be evaluations on the upper limb motor functions before and after the 20-session of training and follow up session by clinical assessments on functional recovery.
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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-
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Hong Kong, Hong Kong
- The Hong Kong Polytechnic University
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Subjects with a pure unilateral motor paresis after a stroke (ischemic or hemorrhagic). All subjects should have sufficient cognition to follow simple instructions as well as understand the content and purpose of the experiment, and also should be able to sit up for 1 hour.
Exclusion Criteria:
- Excessive spasticity of the affected arm
- Participation in any therapeutic treatment ("outside therapy") performed with the paralyzed arm during the planned study - including baseline and follow up.
Plano de estudo
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: Hand Robotic Training
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Training for 20 sessions for one hour, 3-5 times per week.
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Experimental: Hand and Arm Robotic Training
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Training for 20 sessions for one hour, 3-5 times per week.
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Comparador Ativo: Terapia convencional
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Training for 20 sessions for one hour, 3-5 times per week.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Fugl-Meyer Assessment
Prazo: Change from baseline Fugl-Meyer Assessment at the end of intervention, at three months and at six months
|
Evaluate the change from baseline assessment at the end of intervention and monitor the continuous change at three months and six months. Baseline assessment will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention. |
Change from baseline Fugl-Meyer Assessment at the end of intervention, at three months and at six months
|
|
Action Research Arm Test
Prazo: Change from baseline Action Research Arm Test at the end of intervention, at three months and at six months
|
Evaluate the change from baseline test at the end of intervention and monitor the continuous change at three months and six months. Baseline test will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention. |
Change from baseline Action Research Arm Test at the end of intervention, at three months and at six months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Wolf Motor Function Test
Prazo: Change from baseline Wolf Motor Function Test at the end of intervention, at three months and at six months
|
Evaluate the change from baseline test at the end of intervention and monitor the continuous change at three months and six months. Baseline test will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention. |
Change from baseline Wolf Motor Function Test at the end of intervention, at three months and at six months
|
|
modified Ashworth Scale
Prazo: Change from baseline modified Ashworth Scale at the end of intervention, at three months and at six months
|
Evaluate the change from baseline test at the end of intervention and monitor the continuous change at three months and six months. Baseline test will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention. |
Change from baseline modified Ashworth Scale at the end of intervention, at three months and at six months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Raymond KY Tong, PhD, The Hong Kong Polytechnic University
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ITT/004/12GP
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