The Effect of Virtual Reality Applications on Upper Extremity Functions in Patients With Duchenne Muscular Dystrophy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age7-18
SponsorIstanbul University
About this trial
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.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical diagnosis of Duchenne Muscular Dystrophy (DMD)
Age ≥ 7 years
Ambulatory or non-ambulatory status (both are eligible)
Ability to follow movement instructions
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual Reality + Conventional Physiotherapy
BehavioralThis 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 Physiotherapy
BehavioralThis 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 Platform
Other interventionBefore 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.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: Virtual Reality + Conventional PhysiotherapyExperimental treatment 2 interventions
Group B: Conventional PhysiotherapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
Baseline, 8 weeks, and 4-week follow-up2
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.
Time frame
Baseline, 8 weeks, and 4-week follow-up3
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.
Time frame
Baseline, 8 weeks, and 4-week follow-upSecondary outcomes
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.
Time frame
Baseline, 8 weeks, and 4-week follow-up2
Pinch Grip Strength Using Jamar Pinch Gauge
Measurement of lateral pinch strength in kilograms using a standardized hand-held dynamometer.
Time frame
Baseline, 8 weeks, and 4-week follow-up3
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.
Time frame
Baseline, 8 weeks, and 4-week follow-up4
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.
Time frame
Baseline, 8 weeks, and 4-week follow-upOther outcomes
1
The System Usability Scale
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.
Time frame
Day 1 (Immediately after a single VR session)2
The Game User Experience Satisfaction Scale - Enjoyment Subscale (GUES-Enjoyment)
The Game User Experience Satisfaction Scale - Enjoyment Subscale (GUES-Enjoyment) is a subscale used to assess the level of enjoyment and engagement experienced during gameplay. Items are rated on a 7-point Likert scale, with higher scores reflecting greater enjoyment and satisfaction related to the gaming experience. Higher scores indicate greater perceived enjoyment.
Time frame
Day 1 (Immediately after a single VR session)3
Perceived Ease of Use
Perceived Ease of Use will be assessed using a 5-point Likert-type rating scale evaluating how easy participants perceive the VR games to use and interact with. Minimum score: 1; Maximum score: 5. Higher scores indicate greater perceived ease of use.
Time frame
Day 1 (Immediately after a single VR session)4
The Virtual Reality Sickness Questionnaire (VRSQ)
The Virtual Reality Sickness Questionnaire (VRSQ) is a self-report questionnaire used to evaluate VR-related discomfort symptoms experienced during or after exposure to immersive virtual environments. The questionnaire assesses symptoms such as dizziness, nausea, eye strain, and disorientation. Higher scores indicate greater VR-related discomfort and symptom severity.
Time frame
Day 1 (Immediately after a single VR session)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Istanbul University
Lead sponsor
Istanbul University - Cerrahpasa
Sponsor institution
Source ClinicalTrials.gov