Duchenne Muscular Dystrophy (DMD)DMD-VR-UENCT07565272
Usability and User Experience of a Virtual Reality Rehabilitation Game Platform in Individuals With Duchenne Muscular Dystrophy
An observational study of Duchenne Muscular Dystrophy (DMD), run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 7 years and older, men only
- Conditions the study is for
- Duchenne Muscular Dystrophy (DMD)
- What is being tested?
- Virtual Reality Gameplay Session
- How many people
- 6 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Apr 2026to 28 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istanbul University - Cerrahpasa
Istanbul, 34758
About this study
Official title: 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.
Read the 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.
- Conditions
- Duchenne Muscular Dystrophy (DMD)
- Being tested
- Virtual Reality Gameplay Session
- Keywords
- duchenne muscular dystrophy, virtual reality, rehabilitation, usability, user experience, upper extremity, Game-based rehabilitation, hand tracking, Pediatric rehabilitation, neuromuscular disease
- Medical subject headings
- Muscular Dystrophy, Duchenne, Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Gameplay SessionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Virtual Reality Gameplay Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Immediately after the single-session gameplay
Secondary outcomes (1)
Qualitative User Feedback
Qualitative feedback will be collected using open-ended questions to explore participants' experiences, perceived difficulties, and suggestions for improvement.
Measured: Immediately after the single-session gameplay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start28 Apr 2026 (estimated)
- Primary completion28 May 2026 (estimated)
- Study completion28 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duchenne Muscular Dystrophy (DMD)Studies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- Health Institutes of Turkey
- Responsible party
- Principal investigator, Sahra Şirvan, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07565272
- Sponsor's protocol ID
- DMD-VR-UE
- Acronym
- DMD-VR-UE
- Status last verified
- Apr 2026
- First submitted
- 27 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- User Experience and Usability of a Disease-Specific Virtual Reality Rehabilitation Game Platform for Individuals With Duchenne Muscular Dystrophy: A Formative Evaluation
- ClinicalTrials.gov ID
- NCT07565272
- Acronym / sponsor ID
- DMD-VR-UE / DMD-VR-UE
- Conditions
- Duchenne Muscular Dystrophy (DMD)
- Keywords
- duchenne muscular dystrophy, virtual reality, rehabilitation, usability, user experience, upper extremity, Game-based rehabilitation, hand tracking
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Collaborators
- Health Institutes of Turkey
- Study start
- 28 Apr 2026 (estimated)
- Primary completion
- 28 May 2026 (estimated)
- Study completion
- 28 Jun 2026 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DMD Participants | – | Other: Virtual Reality Gameplay SessionIndividuals with Duchenne muscular dystrophy who participate in a single-session virtual reality-based rehabilitation gameplay experience to evaluate usability, user experience, and tolerability. |
Who may qualify
- Ages
- 7 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Gameplay SessionParticipants interact with a disease-specific virtual reality rehabilitation game platform using a fully immersive headset with hand-tracking technology during a single supervised session. | Other | DMD Participants |
Primary outcome
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.
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.
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.
1 secondary outcome
Qualitative User Feedback
Time frame: Immediately after the single-session gameplay
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Duchenne Muscular Dystrophy (DMD), run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability (System Usability Scale) (time frame: Immediately after the single-session gameplay). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.