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

NCT07039799 | Not Yet Recruiting DMC

• 1 other identifier: SSirvan
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Duchenne Muscular Dystrophy (DMD); Virtual Reality

Keywords

Duchenne Muscular Dystrophy; Virtual Reality; Upper Extremity

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline, 8 weeks, and 4-week follow-up

Secondary Outcomes (7)

• ABILHAND-Kids Manual Ability Scale

  Baseline, 8 weeks, and 4-week follow-up

• Pinch Grip Strength Using Jamar Pinch Gauge

  Baseline, 8 weeks, and 4-week follow-up

• Nine-Hole Peg Test (9HPT)

  Baseline, 8 weeks, and 4-week follow-up

• Trunk Control Measurement Scale (TCMS)

  Baseline, 8 weeks, and 4-week follow-up

• Multidimensional Fatigue Scale (PedsQL Fatigue Scale)

  Baseline, 8 weeks, and 4-week follow-up

Study Arms (2)

Virtual Reality + Conventional Physiotherapy

EXPERIMENTAL

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.

Behavioral: Virtual Reality + Conventional Physiotherapy

Conventional Physiotherapy

ACTIVE COMPARATOR

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.

Behavioral: Conventional Physiotherapy

Interventions

Virtual Reality + Conventional Physiotherapy 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).

Virtual Reality + Conventional Physiotherapy

Conventional Physiotherapy 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.

Conventional Physiotherapy

Eligibility Criteria

• Age: 7 Years - 18 Years
• Gender Eligibility Details: Since Duchenne Muscular Dystrophy disease is seen in males, it was planned to include male individuals in this study.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Related Publications (2)

• 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.

  PMID: 25196721 BACKGROUND

• 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.

  PMID: 39063545 BACKGROUND

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Sahra Şirvan Tongar, MSc.

CONTACT

+905319249229; csahrasirvan@gmail.com

Yonca Zenginler Yazgan, Associate Professor

CONTACT

+905326006294; y.zenginleryazgan@iuc.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc Physiotherapist

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: June 26, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): August 15, 2027
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share