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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
36
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).
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.
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.
İstanbul Üniversitesi Cerrahpaşa Tıp Fakültesi
Istanbul, Fatih, Turkey (Türkiye)
RECRUITINGPerformance 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-up
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-up
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-up
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-up
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-up
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-up
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-up
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.
Time frame: Baseline, 8 weeks, and 4-week follow-up
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.
Time frame: Baseline, 8 weeks, and 4-week follow-up
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.
Time frame: Post-intervention (8 weeks)
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