A Randomized Controlled Trial of Bilateral Movement-based Computer Games Training to Improve Motor Function of Upper Limb and Quality of Life in Sub-acute Stroke Patient
5 de agosto de 2018 atualizado por: Lam So Ling, Stefanie, Shatin Hospital
This study aims at investigating whether bilateral movement-based training with computer games could augment motor function of paretic upper limb and improve quality of life in sub-acute stroke patients.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
93
Estágio
- Não aplicável
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
45 anos a 85 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Age between 45-85
- Diagnosis of ischaemic brain injury or intracerebral hemorrhage by MRI or computed tomography 1 week to 6 months after the onset of current stroke
- Scoring > 6 of 10 of Abbreviated Mental Test
- Ability of the paretic hand to hold the game controller (minimal control)
- Able to give informed consent of the study
- Can understand instructions given by English or Cantonese
Exclusion Criteria:
- Any additional medical, cardiovascular and orthopaedic condition that would hinder the proper assessment and treatment
- Having cardiac pacemaker
- Receptive dysphasia
- Undergoing drug studies or other clinical trials
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 |
|---|---|
|
Experimental: Bilateral movement-based computer training
All subjects underwent 16 sessions of assigned treatment (2 times per week; for 8 weeks; 3 hours standardized rehabilitation program per visit) There was 1.5 hours standardized conventional physiotherapy training a 1.5 hours multi-disciplinary program which consisted of standardized occupational therapy, speech therapy and nursing care. Subjects in Intervention Group will be assigned an additional 30 minutes bilateral movement-based computer games(Able-X) training program of upper limb. |
|
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Outro: Video-directed conventional training
All subjects underwent 16 sessions of assigned treatment (2 times per week; for 8 weeks; 3 hours standardized rehabilitation program per visit) There was 1.5 hours standardized conventional physiotherapy training a 1.5 hours multi-disciplinary program which consisted of standardized occupational therapy, speech therapy and nursing care.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE scores) baseline to 4 weeks
Prazo: Change from baseline to 4 weeks
|
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index.
It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment.
The FMA-UE scores measure motor impairment of upper extremity.
The motor domain includes items assessing movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist and hand.
|
Change from baseline to 4 weeks
|
|
Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE scores) baseline to 8 weeks
Prazo: Change from baseline to 8 weeks
|
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index.
It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment.
The FMA-UE scores measure motor impairment of upper extremity.
The motor domain includes items assessing movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist and hand.
|
Change from baseline to 8 weeks
|
|
Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE scores) baseline to followup
Prazo: Change from baseline to 12 weeks (4 weeks after training ended)
|
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index.
It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment.
The FMA-UE scores measure motor impairment of upper extremity.
The motor domain includes items assessing movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist and hand.
|
Change from baseline to 12 weeks (4 weeks after training ended)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Action Research Arm Test (ARAT) baseline to 4 weeks
Prazo: Change from baseline to 4 weeks
|
The Action Research Arm Test (ARAT) is an evaluative measure to assess specific changes in limb function among individuals who sustained cortical damage resulting in hemiplegia.
It assesses a client's ability to handle objects differing in size, weight and shape and therefore can be considered to be an arm-specific measure of activity limitation.
|
Change from baseline to 4 weeks
|
|
Action Research Arm Test (ARAT) baseline to 8 weeks
Prazo: Change from baseline to 8 weeks
|
The Action Research Arm Test (ARAT) is an evaluative measure to assess specific changes in limb function among individuals who sustained cortical damage resulting in hemiplegia.
It assesses a client's ability to handle objects differing in size, weight and shape and therefore can be considered to be an arm-specific measure of activity limitation.
|
Change from baseline to 8 weeks
|
|
Action Research Arm Test (ARAT) baseline to followup
Prazo: Change from baseline to 12 weeks (4 weeks after training ended)
|
The Action Research Arm Test (ARAT) is an evaluative measure to assess specific changes in limb function among individuals who sustained cortical damage resulting in hemiplegia.
It assesses a client's ability to handle objects differing in size, weight and shape and therefore can be considered to be an arm-specific measure of activity limitation.
|
Change from baseline to 12 weeks (4 weeks after training ended)
|
|
Short-Form Health Survey Hong Kong version (HK-SF-36) baseline to 4 weeks
Prazo: Change from baseline to 4 weeks
|
The Short-Form Health Survey (SF-36) is a widely used, generic, patient-report measure created to assess health-related quality of life (HRQOL) in the general population.
SF-36 is the most commonly used generic instrument for measuring quality of life.
|
Change from baseline to 4 weeks
|
|
Short-Form Health Survey Hong Kong version (HK-SF-36) baseline to 8 weeks
Prazo: Change from baseline to 8 weeks
|
The Short-Form Health Survey (SF-36) is a widely used, generic, patient-report measure created to assess health-related quality of life (HRQOL) in the general population.
SF-36 is the most commonly used generic instrument for measuring quality of life.
|
Change from baseline to 8 weeks
|
|
Short-Form Health Survey Hong Kong version (HK-SF-36) baseline to followup
Prazo: Change from baseline to 12 weeks (4 weeks after training ended)
|
The Short-Form Health Survey (SF-36) is a widely used, generic, patient-report measure created to assess health-related quality of life (HRQOL) in the general population.
SF-36 is the most commonly used generic instrument for measuring quality of life.
|
Change from baseline to 12 weeks (4 weeks after training ended)
|
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)
3 de agosto de 2015
Conclusão Primária (Real)
1 de fevereiro de 2017
Conclusão do estudo (Real)
1 de fevereiro de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
6 de outubro de 2017
Enviado pela primeira vez que atendeu aos critérios de CQ
5 de agosto de 2018
Primeira postagem (Real)
7 de agosto de 2018
Atualizações de registro de estudo
Última Atualização Postada (Real)
7 de agosto de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
5 de agosto de 2018
Última verificação
1 de agosto de 2018
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- HMRF02133096
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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