Home-based -Virtual Reality Intervention for Stroke Rehabilitation (Home-VR)
Virtual Reality Intervention for Stroke Rehabilitation - Home Based (Stage 2)
On-going rehabilitation is needed to maintain and improve the weaker upper extremity following stroke. Community rehabilitation programs for stroke individuals in the chronic stage are often difficult to be implement. Consequently, many individuals remain without structured interventional programs. Self-training programs, where individuals can independently continue to exercise at home, might answer this challenge. However, since exercising alone is boring and not motivating, individuals often stop the prescribed exercises and remain inactive. The use of video-games for self-training might answer this challenge.
Therefore, the investigators aimed to assess the feasibility of using video-games for self-training after stroke. Specifically the investigators aim to compare the (1) training time, (2) satisfaction and (3) effectiveness of a self-training program using video-games compared to a traditional self-training program.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a single-blind randomized controlled trial with four assessments; two before and two following the 5-week self training intervention.
Individuals are requested to perform the self training (video-games or traditional exercises) 60 minutes a day for 5 weeks.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Ramat Gan, Israel
- Sheba Medical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 6 to 36 months after stroke onset
- lived in the community with family or a caregiver
- mild to moderate weakness the affected upper extremity
- without significant cognitive deficit
- able to walk at least 10-meters (with or without assistance).
Exclusion Criteria:
- Other neurological conditions
- Epilepsy
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 |
|---|---|
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Experimental: self-training using video-games
Participants will receive a video-game console and will be asked to play video-games for one hour a day X 6 days a week for 5 weeks.
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Individuals will receive a video-game console and will be taught how to play the games. They will be requested to play 60 minutes a day for 5 weeks. |
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Comparador activo: traditional self-training
Participants will receive a manual and kit of a traditional self-training program and will be asked to perform the program one hour a day X 6 days a week for 5 weeks.
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Individuals will receive a manual and equipment and will be taught how to perform the exercises.
They will be requested to perform the exercises 60 minutes a day for 5 weeks.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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self-training time
Periodo de tiempo: week 9
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Self-training time for the 5-week program as documented on a daily log sheet by the participants in both self-training programs.
The mean weekly training hours per week will also be calculated.
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week 9
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Change in Action Research Arm Test
Periodo de tiempo: week 0, week 4, week 9, week 13
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change in functional ability of the weaker upper extremity
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week 0, week 4, week 9, week 13
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Box and Block Test
Periodo de tiempo: week 0, week 4, week 9, week 13
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Change in dexterity of the weaker upper extremity as assessed by the Box and Block Test
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week 0, week 4, week 9, week 13
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Change in The Functional Reach Test
Periodo de tiempo: week 4, week 9, week 13
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Change in standing balance
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week 4, week 9, week 13
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Daily enjoyment from the self-training
Periodo de tiempo: week 9
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For each daily session participants rated their perceived enjoyment (1-5 points).
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week 9
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Change in the Motor Activity Log (MAL)
Periodo de tiempo: week 0, week 4, week 9, week 13
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Change in daily use of the weaker upper extremity by using the MAL.
This self-report questionnaire generates two seperate scores ranging from 0 to 5, regarding the amount and quality of the weaker upper extremity
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week 0, week 4, week 9, week 13
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Daily exertion from the self-training
Periodo de tiempo: week 9
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For each daily session participants rated their perceived exertion (6-20 on the Borg scale).
A mean score will be calculated per week.
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week 9
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Satisfaction from the self-training program
Periodo de tiempo: week 9
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Satisfaction from the 5-week program and their perceived benefit from the program for improving their weaker upper extremity and balance on a 5-point Likert scale from "not at all" to "very much".
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week 9
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Debbie Rand, OT, PhD, Tel Aviv University
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SHEBA-14-1764-HW-CTIL
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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