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NCT Number: NCT07565272

Usability and User Experience of a Virtual Reality Rehabilitation Game Platform in Individuals With Duchenne Muscular Dystrophy

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality Gameplay Session

Other

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.

Primary outcomes

  1. Usability (System Usability Scale)

    Time frame: Immediately after the single-session gameplay

    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.

  2. Virtual Reality-Related Discomfort (Virtual Reality Sickness Questionnaire)

    Time frame: Immediately after the single-session gameplay

    Virtual reality-related discomfort will be assessed using the Virtual Reality Sickness Questionnaire (VRSQ), which evaluates symptoms associated with immersive virtual reality exposure.

  3. Enjoyment (GUES - Game User Experience Satisfaction Scale - Enjoyment Subscale)

    Time frame: Immediately after the single-session gameplay

    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.

Secondary outcomes

  1. Qualitative User Feedback

    Time frame: Immediately after the single-session gameplay

    Qualitative feedback will be collected using open-ended questions to explore participants' experiences, perceived difficulties, and suggestions for improvement.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Collaborators

  • Health Institutes of Turkey

Registry information

Official study title

User Experience and Usability of a Disease-Specific Virtual Reality Rehabilitation Game Platform for Individuals With Duchenne Muscular Dystrophy: A Formative Evaluation

Acronym: DMD-VR-UE

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 4, 2026
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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