Usability and User Experience of a Virtual Reality Rehabilitation Game Platform in Individuals With Duchenne Muscular Dystrophy (DMD-VR-UE)

April 27, 2026 updated by: Sahra Şirvan, Istanbul University

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34758
        • Istanbul University - Cerrahpasa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately after the single-session gameplay
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.
Immediately after the single-session gameplay
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.
Immediately after the single-session gameplay

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately after the single-session gameplay

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Collaborators

Health Institutes of Turkey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 28, 2026

Primary Completion (Estimated)

May 28, 2026

Study Completion (Estimated)

June 28, 2026

Study Registration Dates

First Submitted

April 27, 2026

First Submitted That Met QC Criteria

April 27, 2026

First Posted (Actual)

May 4, 2026

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DMD-VR-UE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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