- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Quebec
-
Montréal, Quebec, Canadá, H3S 1M9
- Institut de réadaptation Gingras-Lindsay
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: isokinetic lower-limb training
3 times/week for 6 weeks
|
concentric training of the affected plantarflexors, hip flexors and hip extensors
|
Comparador de placebos: isokinetic uppe-limb training
3 times/week for 6 weeks
|
concentric training of the affected wrist extensors, elbow flexors and shoulder flexors
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
change in gait speed
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
change in maximal voluntary concentric strength
Periodo de tiempo: 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRSC-44059
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .