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

Condition(s) studied

Investigational drug(s) / intervention(s)

Virtual Reality + Conventional Physiotherapy: 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 Physiotherapy: 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 Platform: 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 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). 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

Primary outcome measure(s)

• Performance of the Upper Limb (PUL 2.0) Score — Baseline, 8 weeks, and 4-week follow-up
  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.
• Pediatric Quality of Life Inventory - Neuromuscular Module (PedsQL-NM) — Baseline, 8 weeks, and 4-week follow-up
  A participant and parent-reported instrument assessing health-related quality of life in pediatric patients with neuromuscular disorders.
• Participation and Environment Measure for Children and Youth (PEM-CY) — Baseline, 8 weeks, and 4-week follow-up
  A parent-reported measure assessing children's participation and environmental support at home, school, and in the community.

Trial sites (1)

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