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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03062345
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.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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-
Illinois
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Chicago, Illinois, Estados Unidos, 60601
- Rehabilitation Institute of Chicago
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Viabilidade do dispositivo
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Single-User Mode first, Multi-User Mode second
|
Virtual Reality games with the user as the only person required for participation
Outros nomes:
Virtual reality games in which more than one user is required for participation.
Users interact in the virtual environment.
Outros nomes:
|
|
Experimental: Multi-User Mode first, Single-User Mode second
|
Virtual Reality games with the user as the only person required for participation
Outros nomes:
Virtual reality games in which more than one user is required for participation.
Users interact in the virtual environment.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Hand displacement during each session
Prazo: 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)
|
total distance hand moves during all therapy sessions divided by the number of sessions in which a subject participates.
|
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)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Therapy mode amount of use
Prazo: 2 week treatment phase
|
Total amount of time subject spends in their assigned therapy mode during the 2-week treatment phase.
|
2 week treatment phase
|
|
Change in Active Range of Motion
Prazo: 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.
|
Change from baseline in angle of upper extremity movement (shoulder and elbow)
|
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.
|
|
Comparison of Intrinsic Motivation Inventory Score between therapy modes
Prazo: 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.
|
Difference in Intrinsic Motivation Inventory score between single-user and multi-user modes
|
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.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: James Patton, PhD, Shirley Ryan Abilitylab
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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
- STU00204187
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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