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- Ensaio Clínico NCT07565272
Usability and User Experience of a Virtual Reality Rehabilitation Game Platform in Individuals With Duchenne Muscular Dystrophy (DMD-VR-UE)
User Experience and Usability of a Disease-Specific Virtual Reality Rehabilitation Game Platform for Individuals With Duchenne Muscular Dystrophy: A Formative Evaluation
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Duchenne muscular dystrophy (DMD) is a progressive X-linked neuromuscular disorder characterized by muscle degeneration and functional decline. As the disease progresses, upper extremity function becomes increasingly important for maintaining independence in daily activities, particularly after the loss of ambulation.
Virtual reality-based rehabilitation has emerged as a promising approach to enhance motivation, engagement, and adherence to therapeutic activities. However, most existing virtual reality applications are not specifically designed to address the functional characteristics of individuals with DMD, such as progressive muscle weakness, early fatigability, reduced proximal control, and limited range of motion.
This study evaluates a disease-specific virtual reality rehabilitation game platform developed for individuals with DMD. The platform includes multiple game scenarios targeting upper extremity movements such as reaching, grasping, object manipulation, bilateral coordination, and visually guided movements, while minimizing excessive physical demand and fatigue. The games are designed with adjustable difficulty levels and incorporate rest periods to ensure safe and comfortable interaction.
Participants will attend a single supervised study session. After a brief familiarization period, participants will interact with the virtual reality system using a fully immersive headset with hand-tracking technology. The session will include multiple rehabilitation game scenarios adapted to the participant's functional level.
Immediately following the gameplay session, usability, user experience, and tolerability will be assessed using validated questionnaires, including the System Usability Scale (SUS), the Virtual Reality Sickness Questionnaire (VRSQ), and the enjoyment subscale of the Game User Experience Satisfaction Scale (GUES). In addition, qualitative feedback will be collected through open-ended questions to capture participants' perceptions, perceived difficulties, and suggestions for improvement.
This study is designed as a formative evaluation to assess first-time user experience and identify potential areas for improvement in the system before future clinical studies evaluating long-term rehabilitation outcomes.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Locais de estudo
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Istanbul, Turquia (Türkiye), 34758
- Istanbul University - Cerrahpasa
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Clinical diagnosis of Duchenne muscular dystrophy (DMD)
- Aged 7 years and older
- Brooke Upper Extremity Functional Classification level ≤ 4
- Ability to understand and follow simple instructions
- Ability to interact with the virtual reality system using upper extremities
- Willingness to participate and provide informed consent (parental/guardian consent where applicable)
Exclusion Criteria:
- Presence of neurological disorders other than DMD
- Severe visual impairment that prevents interaction with the virtual reality system
- Severe upper extremity contractures or deformities limiting participation
- Cognitive, behavioral, or communication impairments interfering with study procedures
- History of severe motion sickness or intolerance to virtual reality environments
- Any medical condition that may pose a risk during participation, as determined by the investigator
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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DMD Participants
Individuals with Duchenne muscular dystrophy who participate in a single-session virtual reality-based rehabilitation gameplay experience to evaluate usability, user experience, and tolerability.
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Participants interact with a disease-specific virtual reality rehabilitation game platform using a fully immersive headset with hand-tracking technology during a single supervised session.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Usability (System Usability Scale)
Prazo: Immediately after the single-session gameplay
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Usability will be assessed using the System Usability Scale (SUS), a 10-item questionnaire scored from 0 to 100, with higher scores indicating better perceived usability.
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Immediately after the single-session gameplay
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Virtual Reality-Related Discomfort (Virtual Reality Sickness Questionnaire)
Prazo: Immediately after the single-session gameplay
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Virtual reality-related discomfort will be assessed using the Virtual Reality Sickness Questionnaire (VRSQ), which evaluates symptoms associated with immersive virtual reality exposure.
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Immediately after the single-session gameplay
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Enjoyment (GUES - Game User Experience Satisfaction Scale - Enjoyment Subscale)
Prazo: Immediately after the single-session gameplay
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Enjoyment will be assessed using the enjoyment subscale of the Game User Experience Satisfaction Scale (GUES), with higher scores indicating greater perceived enjoyment during gameplay.
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Immediately after the single-session gameplay
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Qualitative User Feedback
Prazo: Immediately after the single-session gameplay
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Qualitative feedback will be collected using open-ended questions to explore participants' experiences, perceived difficulties, and suggestions for improvement.
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Immediately after the single-session gameplay
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
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
- Doenças musculoesqueléticas
- Doenças do Sistema Nervoso
- Doenças Musculares
- Doenças Genéticas, Congênitas
- Doenças Genéticas, Ligadas ao X
- Distúrbios Musculares Atróficos
- Distrofias Musculares
- Doenças e Anormalidades Congênitas, Hereditárias e Neonatais
- Distrofia Muscular, Duchenne
- Doenças Neuromusculares
Outros números de identificação do estudo
- DMD-VR-UE
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
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