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Enrolling by invitation NCT07565272

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

Observational Duchenne Muscular Dystrophy (DMD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual Reality Gameplay Session.
Who it may be relevant to
Registry conditions: Duchenne Muscular Dystrophy (DMD). Basic parameters: from 7 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • 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.

Primary outcome measures

  • Usability (System Usability Scale) [Time frame: Immediately after the single-session gameplay]
  • Virtual Reality-Related Discomfort (Virtual Reality Sickness Questionnaire) [Time frame: Immediately after the single-session gameplay]
  • Enjoyment (GUES - Game User Experience Satisfaction Scale - Enjoyment Subscale) [Time frame: Immediately after the single-session gameplay]
Secondary outcome measures (1)
  • Qualitative User Feedback [Time frame: Immediately after the single-session gameplay]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Turkey (Türkiye) · 1 center
  • Istanbul University - Cerrahpasa — Istanbul

Identifiers

NCT: NCT07565272 · DMD-VR-UE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗