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

NCT ID: NCT07039799

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-15
• Study Completion Date: 2027-08-15

Brief 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.

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.

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.

Conditions

Duchenne Muscular Dystrophy (DMD); Virtual Reality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Virtual Reality + Conventional Physiotherapy

Participants 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.

Group Type: EXPERIMENTAL

Virtual Reality + Conventional Physiotherapy

Intervention Type: BEHAVIORAL

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

Participants 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.

Group Type: ACTIVE_COMPARATOR

Conventional Physiotherapy

Intervention Type: BEHAVIORAL

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.

Interventions

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).

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Sahra Şirvan

MSc Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Sahra Şirvan Tongar, MSc.

Role: CONTACT

csahrasirvan@gmail.com

+905319249229

Yonca Zenginler Yazgan, Associate Professor

Role: CONTACT

y.zenginleryazgan@iuc.edu.tr

+905326006294

References

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.

Reference Type: BACKGROUND

PMID: 25196721 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 39063545 (View on PubMed)

Other Identifiers

SSirvan

Identifier Type: -

Identifier Source: org_study_id