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Duchenne Muscular Dystrophy (DMD)NCT07039799

The Effect of Virtual Reality Applications on Upper Extremity Functions in Patients With Duchenne Muscular Dystrophy

A study testing Virtual Reality + Conventional Physiotherapy, Conventional Physiotherapy and Formative Usability Evaluation of the VR Rehabilitation Platform in people with Duchenne Muscular Dystrophy (DMD) and Virtual Reality, run by Istanbul University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study aims to evaluate the effects of fully immersive virtual reality (VR) applications on upper extremity (UE) functions in individuals diagnosed with Duchenne Muscular Dystrophy (DMD). Read more about this study

Who is it for?
Ages 7 to 18 years, men only
What is being tested?
Virtual Reality + Conventional Physiotherapy, Conventional Physiotherapy and Formative Usability Evaluation of the VR Rehabilitation Platform
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Aug 2025to 15 Aug 2027
Phase
Interventional
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 to 18 years
  • Men only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Clinical diagnosis of Duchenne Muscular Dystrophy (DMD)
  • Age ≥ 7 years
  • Ambulatory or non-ambulatory status (both are eligible)
  • Ability to follow movement instructions
  • Brooke Upper Extremity Functional Rating Scale (BUEFS) level ≤ 4 (i.e., able to bring hand to mouth)

Who cannot join

  • Presence of any neurological diagnosis other than DMD
  • Cognitive, behavioral, or communication impairments that limit participation
  • Systemic illness or condition interfering with participation
  • Severe visual impairments incompatible with VR headset use
  • Presence of severe contractures or deformities that prevent execution of VR-based exercises

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sahra Şirvan Tongar, MSc. contact

+905319249229

csahrasirvan@gmail.com

Yonca Zenginler Yazgan, Associate Professor contact

+905326006294

y.zenginleryazgan@iuc.edu.tr

Turkey (Türkiye)1 site, 1 recruiting
  • İstanbul Üniversitesi Cerrahpaşa Tıp Fakültesi

    Istanbul, Fatih, 34098

    Sahra Şirvan Tongar, MSc., +90 531 924 92 29, csahrasirvan@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

This study aims to evaluate the effects of fully immersive virtual reality (VR) applications on upper extremity (UE) functions in individuals diagnosed with Duchenne Muscular Dystrophy (DMD). DMD is a progressive neuromuscular disorder that leads to muscle weakness and loss of function, including the upper limbs, which are essential for daily activities and independence.

In this randomized controlled trial, 36 participants with DMD will be divided into two groups: a control group receiving conventional physiotherapy and an intervention group receiving the same physiotherapy program (excluding upper extremity exercises) combined with VR-based exercises. The VR games will be designed specifically to improve shoulder, elbow, wrist, and hand functions and will be delivered using Meta Quest 3 headsets with hand-tracking capabilities.

Read more

Both groups will receive therapy twice a week for 8 weeks. Assessments will be conducted before and after the intervention, and at follow-up, using validated tools to measure UE function, grip strength, fine motor skills, trunk control, fatigue, quality of life, and participation in daily activities.

The study aims to explore innovative rehabilitation strategies for DMD and contribute to improving the independence and quality of life of affected individuals.

Read the detailed description

Duchenne Muscular Dystrophy (DMD) is a progressive genetic disorder characterized by the absence of dystrophin, leading to degeneration and weakness of skeletal muscles. While early clinical symptoms primarily affect the lower extremities, upper extremity (UE) dysfunction significantly impacts daily life and independence, especially as the disease progresses and ambulation is lost. Despite its clinical relevance, upper limb rehabilitation remains underrepresented in current treatment strategies, and there is a clear need for innovative and engaging approaches tailored to this population.

Virtual reality (VR) offers an interactive and motivating rehabilitation environment, enabling repetitive task-oriented training in a controlled and safe setting. In recent years, fully immersive VR systems have gained attention in pediatric neurorehabilitation due to their potential to improve motor function while increasing patient engagement and compliance. However, research on the application of VR in DMD, particularly targeting upper limb function, remains limited.

This study is a randomized controlled trial designed to evaluate the impact of immersive VR-based rehabilitation on UE functions in children and adolescents with DMD. A total of 36 participants will be randomly assigned to either an intervention group receiving a combination of conventional physiotherapy and VR-based upper extremity training, or a control group receiving only conventional physiotherapy including aerobic, strengthening, stretching, breathing, posture, and functional exercises.

The VR program includes three custom-developed therapeutic games targeting shoulder, elbow, wrist, and hand movements. These games will be administered using the Meta Quest 3 headset with hand-tracking technology, allowing participants to interact with the virtual environment without additional controllers. The games will be adapted to each participant's functional level, with adjustable difficulty and personalized content. Sessions will take place twice weekly for 8 weeks, with each session lasting approximately 40 minutes.

Outcome measures include standardized clinical tools to assess upper extremity performance (e.g., PUL 2.0, pinch strength, pegboard test), fine motor skills, trunk control, fatigue, health-related quality of life, and participation levels. Usability and potential side effects of VR will also be evaluated through questionnaires and observation during sessions.

Prior to the randomized controlled trial, a preliminary formative usability evaluation was conducted with five individuals with Duchenne muscular dystrophy to assess the feasibility, usability, comfort, and interaction characteristics of the VR rehabilitation games. Feedback obtained from quantitative usability measures, observation, and qualitative user comments was used to refine game mechanics, interaction timing, difficulty progression, hand-tracking sensitivity, and overall gameplay experience before implementation in the main trial.

The findings of this trial are expected to contribute to the evidence base supporting VR as a feasible and effective tool for enhancing upper limb function in children with DMD, and to guide future integration of digital technologies in neuromuscular rehabilitation.

Being tested
Virtual Reality + Conventional Physiotherapy, Conventional Physiotherapy, Formative Usability Evaluation of the VR Rehabilitation Platform
Keywords
Duchenne Muscular Dystrophy, Virtual Reality, Upper Extremity
Medical subject headings
Muscular Dystrophy, Duchenne

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Reality + Conventional PhysiotherapyBehavioural

    This intervention involves the use of fully immersive virtual reality (VR) applications delivered through the Meta Quest 3 headset, integrated with hand-tracking technology. Participants engage in three custom-designed VR games aimed at improving shoulder, elbow, wrist, and hand functions. The games are tailored to individual functional levels and include progressive difficulty. Sessions are conducted twice per week for 8 weeks, each lasting approximately 40 minutes, under the supervision of a physiotherapist. This intervention is combined with conventional physiotherapy (excluding functional upper extremity exercises).

  • Conventional PhysiotherapyBehavioural

    This intervention consists of a standard physiotherapy program for individuals with Duchenne Muscular Dystrophy. It includes aerobic exercises, strengthening exercises, stretching routines, postural training, respiratory exercises, and functional upper extremity exercises. The sessions are delivered by a physiotherapist twice weekly for 8 weeks, with each session lasting approximately 40 minutes.

  • Formative Usability Evaluation of the VR Rehabilitation PlatformOther

    Before initiation of the randomized controlled trial, the VR rehabilitation platform underwent a preliminary formative usability evaluation involving five individuals with Duchenne muscular dystrophy (DMD). During this pre-evaluation phase, perceived usability, enjoyment, ease of use, and potential VR-related discomfort associated with the VR games were assessed using standardized outcome measures, including the System Usability Scale (SUS), the enjoyment subscale of the Game User Experience Satisfaction Scale (GUESS), and the Virtual Reality Sickness Questionnaire (VRSQ). In addition, qualitative user feedback was collected through open-ended questions regarding gameplay experience, perceived difficulties, and suggestions for improvement. Findings from this formative evaluation were used to optimize gameplay mechanics, interaction design, and overall system usability prior to implementation of the randomized controlled trial.

Study groups in NCT07039799
Study groupRoleWhat they receive
Virtual Reality + Conventional PhysiotherapyExperimentalParticipants in this group will receive a conventional physiotherapy program excluding upper extremity (UE) functional exercises. In addition, they will participate in immersive virtual reality (VR)-based rehabilitation sessions using a Meta Quest 3 headset. The VR intervention includes three custom-designed games targeting shoulder, elbow, wrist, and hand movements. These sessions will be administered twice weekly for 8 weeks, with each session lasting approximately 40 minutes. Games are tailored to each participant's functional level and designed to enhance motivation, participation, and UE motor function.
Receives: Behavioral: Virtual Reality + Conventional Physiotherapy; Other: Formative Usability Evaluation of the VR Rehabilitation Platform
Conventional PhysiotherapyActive comparatorParticipants in this group will receive a conventional physiotherapy program including aerobic exercises, strengthening, stretching, posture training, breathing exercises, and functional upper extremity exercises. The sessions will be delivered by physiotherapists twice per week for 8 weeks, each lasting approximately 40 minutes. No virtual reality intervention will be provided in this group.
Receives: Behavioral: Conventional Physiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Performance of the Upper Limb (PUL 2.0) Score

    A clinician-reported outcome measure designed to assess upper limb motor performance in individuals with Duchenne Muscular Dystrophy. It includes tasks at shoulder, mid-level, and distal levels.

    Measured: Baseline, 8 weeks, and 4-week follow-up

  2. Pediatric Quality of Life Inventory - Neuromuscular Module (PedsQL-NM)

    A participant and parent-reported instrument assessing health-related quality of life in pediatric patients with neuromuscular disorders.

    Measured: Baseline, 8 weeks, and 4-week follow-up

  3. Participation and Environment Measure for Children and Youth (PEM-CY)

    A parent-reported measure assessing children's participation and environmental support at home, school, and in the community.

    Measured: Baseline, 8 weeks, and 4-week follow-up

Secondary outcomes (7)
  1. ABILHAND-Kids Manual Ability Scale

    The ABILHAND-Kids is a parent-reported questionnaire designed to measure manual ability in children with upper limb impairments. It contains 21 items scored based on perceived difficulty. Minimum score: 0; Maximum score: 42. Higher scores indicate better manual ability.

    Measured: Baseline, 8 weeks, and 4-week follow-up

  2. Pinch Grip Strength Using Jamar Pinch Gauge

    Measurement of lateral pinch strength in kilograms using a standardized hand-held dynamometer.

    Measured: Baseline, 8 weeks, and 4-week follow-up

  3. Nine-Hole Peg Test (9HPT)

    A timed performance test evaluating fine motor dexterity by measuring the time taken to place and remove pegs using each hand.

    Measured: Baseline, 8 weeks, and 4-week follow-up

  4. Trunk Control Measurement Scale (TCMS)

    The Trunk Control Measurement Scale (TCMS) is a standardized clinical tool used to assess trunk control in children with neuromotor disorders. It evaluates both static and dynamic sitting balance through 15 tasks grouped into three subscales: static sitting balance, selective movement control, and dynamic reaching.Minimum score: 0; Maximum score: 58. Higher scores indicate better trunk control.

    Measured: Baseline, 8 weeks, and 4-week follow-up

  5. Multidimensional Fatigue Scale (PedsQL Fatigue Scale)

    The Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale is a standardized questionnaire used to assess fatigue in children and adolescents. It includes 18 items covering three subscales: General Fatigue, Sleep/Rest Fatigue, and Cognitive Fatigue. Each item is scored on a 5-point Likert scale and then linearly transformed to a 0-100 scale. Minimum score: 0; Maximum score: 100. Higher scores indicate better functioning.

    Measured: Baseline, 8 weeks, and 4-week follow-up

  6. Timed Upper Extremity Functional Tasks (e.g., T-shirt On/Off, Coin Pick-Up)

    A set of timed performance tasks evaluating the duration of functional UE activities.

    Measured: Baseline, 8 weeks, and 4-week follow-up

  7. System Usability Scale - Turkish Version (SUS-TR)

    The System Usability Scale - Turkish Version (SUS-TR) is the Turkish-adapted version of the System Usability Scale, a 10-item questionnaire used to evaluate the perceived usability of a system or product. Each item is rated on a 5-point Likert scale and converted to a composite score ranging from 0 to 100. Minimum score: 0; Maximum score: 100. Higher scores indicate better usability.

    Measured: Post-intervention (8 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2025
  2. Study start15 Aug 2025
  3. Primary completion15 Feb 2027 (estimated)
  4. Study completion15 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07039799
Sponsor's protocol ID
SSirvan
Status last verified
May 2026
First submitted
18 Jun 2025
Last updated
19 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared due to the inclusion of a pediatric and vulnerable population diagnosed with Duchenne Muscular Dystrophy (DMD). To protect participants' privacy and ensure compliance with ethical standards and data protection regulations, data sharing is not planned.

Publications

  • Alemdaroglu I, Karaduman A, Yilmaz OT, Topaloglu H. Different types of upper extremity exercise training in Duchenne muscular dystrophy: effects on functional performance, strength, endurance, and ambulation. Muscle Nerve. 2015 May;51(5):697-705. doi: 10.1002/mus.24451. Epub 2015 Mar 5.

    PubMed 25196721
  • Kiper P, Federico S, Szczepanska-Gieracha J, Szary P, Wrzeciono A, Mazurek J, Luque-Moreno C, Kiper A, Spagna M, Barresi R, Cieslik B. A Systematic Review on the Application of Virtual Reality for Muscular Dystrophy Rehabilitation: Motor Learning Benefits. Life (Basel). 2024 Jun 22;14(7):790. doi: 10.3390/life14070790.

    PubMed 39063545

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality + Conventional Physiotherapy, Conventional Physiotherapy and Formative Usability Evaluation of the VR Rehabilitation Platform in people with Duchenne Muscular Dystrophy (DMD) and Virtual Reality, 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 19 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?

Contact Sahra Şirvan Tongar, MSc. (+905319249229, csahrasirvan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Performance of the Upper Limb (PUL 2.0) Score (time frame: Baseline, 8 weeks, and 4-week follow-up). 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?

On the ClinicalTrials.gov record for NCT07039799, which also lists 2 linked publications.

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 19 May 2026; AzTrials last refreshed its copy on 30 Oct 2026.

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