- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01818349
Impact of Training on Gait and Strength in Stroke Survivors
Gait Performance and Lower-limb Muscle Strength Improved in Both Upper-limb and Lower-limb Isokinetic Training Programs in Individuals With Chronic Stroke
Background: A discrepancy between strength gain and gait changes following various training programs aimed at improving gait function after stroke has been noted. A mismatch between the training program and gait parameters could explain this finding.
Objective: To evaluate the impact of an isokinetic-strengthening program, matching the requirements of the affected lower-limb muscle groups involved in the energy generation of gait, to a control intervention, on gait performance and muscle strength.
Hypothesis: The isokinetic training program of the affected lower-limb muscles would produce greater changes in gait performance and strength than a control intervention not aiming at training these muscle groups.
Design: Single-blinded randomized controlled trial.
Participants: A convenient sample of 30 individuals with chronic hemiparesis.
Interventions: Participants were randomly assigned into two groups (n=15), each training three times/week for six weeks. The experimental group trained the affected plantarflexors, hip flexors and extensors concentrically, while the control group trained the affected upper-limb muscles.
Main outcome measures: Baseline values and post-training values, taken at the end of the training program, of maximal voluntary concentric strength, gait speed and peak positive power.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Quebec
-
Montréal, Quebec, Canadá, H3S 1M9
- Institut de réadaptation Gingras-Lindsay
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- have a chronic (six months or more) unilateral stroke
- be able to walk 10 meters independently with or without a cane
- present residual weakness at the affected lower limb
- have an activity tolerance of at least two hours with a rest period
Exclusion Criteria:
- receptive aphasia
- incontinence
- unstable medical condition
- history of injury
- anesthesia at the lower limbs
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 |
|---|---|
|
Comparador Ativo: isokinetic lower-limb training
3 times/week for 6 weeks
|
concentric training of the affected plantarflexors, hip flexors and hip extensors
|
|
Comparador de Placebo: isokinetic uppe-limb training
3 times/week for 6 weeks
|
concentric training of the affected wrist extensors, elbow flexors and shoulder flexors
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
change in gait speed
Prazo: gait speed was assessed at baseline and at the completion of the 6-week training (i.e. week #7)
|
change in gait speed, in meter/second, was assessed as the difference between the baseline and week #7 values.
|
gait speed was assessed at baseline and at the completion of the 6-week training (i.e. week #7)
|
|
change in peak positive power
Prazo: peak positive power was assessed at baseline and at the completion of the 6-week training (i.e. week #7)
|
peak positive power was evaluated at the affected plantarflexors, hip flexors and hip extensors.
Also, change in peak positive power, in weight/kilogram, was assessed as the difference between the baseline and week #7 values.
|
peak positive power was assessed at baseline and at the completion of the 6-week training (i.e. week #7)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
change in maximal voluntary concentric strength
Prazo: maximal voluntary concentric strength was assessed at baseline and at the completion of the 6-week training (i.e. week #7)
|
maximal voluntary concentric strength was evaluated at the affected plantarflexors, hip flexors and hip extensors.
Also, change in maximal voluntary concentric strength, in Newton-metre, was assessed as the difference between the baseline and week #7 values.
|
maximal voluntary concentric strength was assessed at baseline and at the completion of the 6-week training (i.e. week #7)
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Sylvie Nadeau, PhD, Université de Montréal
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 (Estimativa)
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
- IRSC-44059
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