- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03268798
Unilateral Wrist Extension Training After Stroke
Following stroke, muscle weakness and impaired motor function are expressed in both the more (MA; paretic) and less affected (LA; non-paretic) sides. Although the efficacy of resistance training is well recognized, training the MA limb directly may be initially difficult due to muscular weakness. "Cross-education" is training one side of the body increases strength in the untrained and opposite side. This concept can be applied in strength training when training the more affected sides cannot be initiated. Recently, our lab found six weeks of dorsiflexion resistance training in the LA leg improved the strength of both trained and untrained legs of chronic stroke participants.
The current project explored if cross-education exists in the upper limb in chronic stroke participants and if there are related changes in cortical and spinal cord plasticity. We hypothesized that unilateral strength in the less affected arm could enhance wrist extension strength bilaterally with related neural adoption and improved clinical function.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Stroke produces muscle weakness seen on both more (paretic, MA) and less affected (non-paretic, LA) sides. "Cross-education" is training one side of the body increases strength or motor skill in the same muscles on the untrained side. This can be applied to enhance muscle strength in the MA side and we found that 6 weeks of dorsiflexion resistance training with the LA leg improved strength bilaterally in chronic stroke. To explore if cross-education occurs also in the upper limb after stroke, participants will complete a 5-week unilateral wrist extension training.
Twenty four participants will be recruited, 12 from Rehabilitation Neuroscience laboratory at University of Victoria, 12 from Brain Behaviour Laboratory at University of British Columbia. Before and after training, maximal voluntary contraction wrist extension force was measured with a 6-axis load cell using Cartesian coordinates (Fz = extension). Electromyography of extensor and flexor carpi radialis, biceps and triceps brachii were recorded. Fugl-Meyer and partial Wolf Motor Function Test were performed by the same physical therapist at each location. Reciprocal inhibition from wrist flexors to extensors, cutaneous reflexes evoked by median and superficial radial nerve stimulation were assessed in those at UVIC. Cortical silent period, short-interval intracortical inhibition, intracortical facilitation and transcallosal inhibition from transcranial magnetic stimulation were measured in participants at UBC.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Over 6 months post-stroke;
- One side of arm shows muscle weakness
- Pass the screening test of Physical Activity Readiness Questionnaire
- Pass the screening test for dementia
- Free from dementia (score < 24 on the Montreal Cognitive Assessment) and any other contradiction for TMS test
Exclusion Criteria:
- Had medication affecting muscle tone within the past 3 months
- Wear a pacemaker
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Wrist extension training
|
Participants will join a five-week training protocol with 3 sessions per week.
During each session, 5 sets 5 maximal wrist extension training will be performed on participants less affected side.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Changes in wrist extension force
Prazo: Week1-3: baselines were measured once per week for three times; Week 4-8: training(no measurement was taken); Week 9: post-test; Week 13: follow-up test
|
To test if training could improve wrist extension strength, maximal wrist extension force were measured in both arms during the 3 baseline pretests, 1 post-test.
There was a week in between each baseline tests, post-test will be performed within one week after the training finished.
To test if the force changes maintained after training, follow-up test was performed 5 weeks after training finished.
|
Week1-3: baselines were measured once per week for three times; Week 4-8: training(no measurement was taken); Week 9: post-test; Week 13: follow-up test
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Changes in the modulation of spinal-mediated muscle reflexes
Prazo: Week1-3: baselines were measured once per week for three times; Week 4-8: training(no measurement was taken); Week 9: post-test;
|
To test if training could induce neural adaptation at spinal level, spinal-mediated muscle reflexes include reciprocal inhibition and cutaneous reflexes in the wrist extensor muscle were measured.
Muscle reflex amplitudes were compared before and after training.
There was no follow-up test for this measurement
|
Week1-3: baselines were measured once per week for three times; Week 4-8: training(no measurement was taken); Week 9: post-test;
|
|
Neural adaptation in the corticospinal pathway
Prazo: Week1-3: baselines were measured once per week for three times; Week 4-8: training(no measurement was taken); Week 9: post-test;
|
To test if training could induced neural adaptation at corticospinal level, cortical silent period, short-interval intracortical inhibition, intracortical facilitation and transcallosal from transcranial magnetic stimulation were measured in wrist extensor muscle.
Changes in the muscle reflex amplitudes and cortical silent period duration were compared before and after training.
There was no follow-up test for this measurement.
|
Week1-3: baselines were measured once per week for three times; Week 4-8: training(no measurement was taken); Week 9: post-test;
|
|
Upper limb impairment assessments
Prazo: Week1-3: baselines were measured once per week for three times; Week 4-8: training(no measurement was taken); Week 9: post-test;
|
Fugl-Meyer test score were assessed by licensed physiotherapists.
Scores were compared before and after training.
There was no follow-up test for this measurement.
|
Week1-3: baselines were measured once per week for three times; Week 4-8: training(no measurement was taken); Week 9: post-test;
|
|
Upper limb function assessments
Prazo: Week1-3: baselines were measured once per week for three times; Week 4-8: training (no measurement was taken); Week 9: post-test; Week 13: follow-up test
|
Wolf Motor Function Test were assessed by licensed physiotherapists.
Scores were compared before and after training.
|
Week1-3: baselines were measured once per week for three times; Week 4-8: training (no measurement was taken); Week 9: post-test; Week 13: follow-up test
|
|
Ten-meter walking test
Prazo: Week1-3: baselines were measured once per week for three times; Week 4-8: training (no measurement was taken); Week 9: post-test;
|
Walking speed was compared before and after training.
There was no follow-up test for this measurement
|
Week1-3: baselines were measured once per week for three times; Week 4-8: training (no measurement was taken); Week 9: post-test;
|
|
Six-minute walking test
Prazo: Week1-3: baselines were measured once per week for three times; Week 4-8: training(no measurement was taken); Week 9: post-test;
|
Walking distance was compared before and after training.
There was no follow-up test for this measurement
|
Week1-3: baselines were measured once per week for three times; Week 4-8: training(no measurement was taken); Week 9: post-test;
|
|
Timed up and go
Prazo: Week1-3: baselines were measured once per week for three times; Week 4-8: training(no measurement was taken); Week 9: post-test;
|
Walking speed was compared before and after training.
There was no follow-up test for this measurement.
|
Week1-3: baselines were measured once per week for three times; Week 4-8: training(no measurement was taken); Week 9: post-test;
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: E.Paul Zehr, Rehabilitation Neuroscience Laboratory, University of Victoria
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 (Real)
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
- D015017-2011-2015
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .