An observational study in Duchenne Muscular Dystrophy (DMD), sponsored by Istanbul University. Enrolling by invitation at 1 site in Turkey (Türkiye). Open to male participants aged 7 Years and older. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by Istanbul University · Observational
This study aims to evaluate the usability, user experience, and tolerability of a virtual reality-based rehabilitation game platform specifically developed for individuals with Duchenne muscular dystrophy. Participants will complete a single-session gameplay experience using an immersive virtual reality headset with hand-tracking technology. Following the gameplay session, usability, enjoyment, and potential virtual reality-related discomfort will be assessed using standardized questionnaires and qualitative feedback. The study is exploratory and formative in nature and does not aim to evaluate clinical effectiveness.
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.
473 studies on the registry are indexed under Muscular Dystrophy, Duchenne; 107 are open to participants now.
This study's planned enrollment of 6 is below the median of 60 across 130 observational studies indexed under Muscular Dystrophy, Duchenne.
Browse Muscular Dystrophy, Duchenne studies →Istanbul University is the lead sponsor of 496 studies on the registry; 79 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
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The study population consists of individuals with a clinical diagnosis of Duchenne muscular dystrophy (DMD) who are able to interact with a virtual reality-based rehabilitation system. Participants are primarily pediatric and adolescent males with varying levels of upper extremity function, including both ambulatory and non-ambulatory individuals. All participants are required to have sufficient cognitive and physical ability to understand instructions and engage in a single-session virtual reality gameplay experience.
Exclusion Criteria:
Individuals with Duchenne muscular dystrophy who participate in a single-session virtual reality-based rehabilitation gameplay experience to evaluate usability, user experience, and tolerability.
Other: Virtual Reality Gameplay Session
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.
Usability (System Usability Scale)
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.
Time frame: Immediately after the single-session gameplay
Virtual Reality-Related Discomfort (Virtual Reality Sickness Questionnaire)
Virtual reality-related discomfort will be assessed using the Virtual Reality Sickness Questionnaire (VRSQ), which evaluates symptoms associated with immersive virtual reality exposure.
Time frame: Immediately after the single-session gameplay
Enjoyment (GUES - Game User Experience Satisfaction Scale - Enjoyment Subscale)
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.
Time frame: Immediately after the single-session gameplay
Qualitative User Feedback
Qualitative feedback will be collected using open-ended questions to explore participants' experiences, perceived difficulties, and suggestions for improvement.
Time frame: Immediately after the single-session gameplay
Plan to share: Undecided — Individual participant data (IPD) sharing has not yet been determined. Any future decision regarding data sharing will depend on institutional policies, ethical approvals, and data protection regulations. If data sharing is considered, all data will be de-identified to ensure participant confidentiality.
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Istanbul University