In Home VR Therapy
Multi-user Virtual Training for Upper Extremity in the Home
Virtual reality is a video game in which a person and their real-time movements are represented on a screen in a virtual environment. This study will compare the use of multi-user virtual reality (VR) to single-user VR to determine if either provides superior engagement in upper extremity therapy and greater motivation to perform repetitive training.
Stroke survivors will participate in a longitudinal study in which they will have the opportunity to perform rehabilitative training with multi-user VR and single-user VR modes in their homes. They will use each mode for 2 weeks, completing 4 session per week, each session is 1 hour long. Upper extremity motor control, level of engagement, and active range of motion will be assessed at time points during the intervention period.
Subject evaluations will take place before the intervention, at the midpoint of intervention (between switching from multi-user to single-user modes, or vice versa), and at the end of the intervention.
The investigators hope to address two aims:
Aim 1: To determine if the use in-home multi-user virtual reality treatment results in greater engagement in therapy compared with in-home single user virtual reality treatment.
Aim 2: To determine if in-home virtual reality treatment results in greater practice
The investigators hypothesize that stroke survivors will be more engaged in therapy when training with the multi-user VR system and this will translate into greater practice.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Illinois
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Chicago, Illinois, Estados Unidos, 60601
- Rehabilitation Institute of Chicago
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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:
- Are between the ages of 21 and 80
- Experienced a single stroke at least 6 months prior to enrollment
- Have moderate arm impairment as indicated by a score between 4 and 6 on the Chedoke-McMaster Stroke Assessment, arm subscale
- Live within 20 miles of the Rehabilitation Institute of Chicago (as study personnel will need to travel to their home)
Exclusion Criteria:
- Other neurological, neuromuscular, or orthopedic disease
- Pain in the upper extremity with movements required in the treatment
- Contracture that limits use of the VR system
- Vision problems which would preclude the ability to use the VR system
- Cognitive or language deficits that would prevent them from understanding the tasks
- Concurrent enrollment in another intervention study involving the affected arm or hand
- Botox injection in the arm within the previous 6 months
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Viabilidad del dispositivo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Single-User Mode first, Multi-User Mode second
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Virtual Reality games with the user as the only person required for participation
Otros nombres:
Virtual reality games in which more than one user is required for participation.
Users interact in the virtual environment.
Otros nombres:
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Experimental: Multi-User Mode first, Single-User Mode second
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Virtual Reality games with the user as the only person required for participation
Otros nombres:
Virtual reality games in which more than one user is required for participation.
Users interact in the virtual environment.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Hand displacement during each session
Periodo de tiempo: Distance hand moves on average per session during each 2-week treatment phase (each subject will complete 2, 2-week phases of treatment. One 2-week phase being the Single-user mode and the other 2-week phase being the Multi-user mode)
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total distance hand moves during all therapy sessions divided by the number of sessions in which a subject participates.
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Distance hand moves on average per session during each 2-week treatment phase (each subject will complete 2, 2-week phases of treatment. One 2-week phase being the Single-user mode and the other 2-week phase being the Multi-user mode)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Therapy mode amount of use
Periodo de tiempo: 2 week treatment phase
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Total amount of time subject spends in their assigned therapy mode during the 2-week treatment phase.
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2 week treatment phase
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Change in Active Range of Motion
Periodo de tiempo: First measure taken at baseline, then also at the end of the first 2-week treatment phase and finally at the end of the second 2-week treatment phase.
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Change from baseline in angle of upper extremity movement (shoulder and elbow)
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First measure taken at baseline, then also at the end of the first 2-week treatment phase and finally at the end of the second 2-week treatment phase.
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Comparison of Intrinsic Motivation Inventory Score between therapy modes
Periodo de tiempo: First measure taken at the end of the first 2-week treatment phase; Second measure taken at the end of the second 2-week treatment phase.
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Difference in Intrinsic Motivation Inventory score between single-user and multi-user modes
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First measure taken at the end of the first 2-week treatment phase; Second measure taken at the end of the second 2-week treatment phase.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: James Patton, PhD, Shirley Ryan Abilitylab
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
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
- STU00204187
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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