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

NCT07565272 | Enrolling By Invitation DMC

• 1 other identifier: DMD-VR-UE
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Duchenne Muscular Dystrophy (DMD)

Keywords

duchenne muscular dystrophy; virtual reality; rehabilitation; usability; user experience; upper extremity; Game-based rehabilitation; hand tracking; Pediatric rehabilitation; neuromuscular disease

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Immediately after the single-session gameplay

Secondary Outcomes (1)

• Qualitative User Feedback

  Immediately after the single-session gameplay

Study Arms (1)

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

Interventions

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.

DMD Participants

Eligibility Criteria

• Age: 7 Years+
• Gender Eligibility Details: Duchenne muscular dystrophy (DMD) is an X-linked recessive genetic disorder caused by mutations in the dystrophin gene located on the X chromosome. Because males have only one X chromosome (XY), the presence of a pathogenic mutation in this gene leads to the clinical manifestation of the disease. In contrast, females have two X chromosomes (XX), and a mutation in one copy is typically compensated by the normal allele on the other chromosome. Therefore, females are usually asymptomatic carriers. For this reason, DMD predominantly affects males, while clinically affected females are extremely rare.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead
• Health Institutes of Turkey: collaborator

Study Sites (1)

Istanbul University - Cerrahpasa

Istanbul, 34758, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne; Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 4, 2026
• Study Start: April 28, 2026
• Primary Completion (Estimated): May 28, 2026
• Study Completion (Estimated): June 28, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

TU (1)