RecruitingNot ApplicableNCT07039799

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


Sponsor

Istanbul University

Enrollment

36 participants

Start Date

Aug 15, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 7 YearsMax Age: 18 Years

Inclusion Criteria5

  • 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)

Exclusion Criteria5

  • 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

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Interventions

BEHAVIORALVirtual 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).

BEHAVIORALConventional 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.

OTHERFormative 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.


Locations(1)

İstanbul Üniversitesi Cerrahpaşa Tıp Fakültesi

Istanbul, Fatih, Turkey (Türkiye)

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NCT07039799


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