The Effect of Virtual Reality Applications on Upper Extremity Functions in Patients With Duchenne Muscular Dystrophy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Performance of the Upper Limb (PUL 2.0) Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Virtual Reality + Conventional Physiotherapy (Behavioral)
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.
干预措施: Conventional Physiotherapy (Behavioral)
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.
干预措施: Formative Usability Evaluation of the VR Rehabilitation Platform (Other)
结局指标
主要结局
Performance of the Upper Limb (PUL 2.0) Score
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- 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)
- Timed Upper Extremity Functional Tasks (e.g., T-shirt On/Off, Coin Pick-Up)(Baseline, 8 weeks, and 4-week follow-up)
- System Usability Scale - Turkish Version (SUS-TR)(Post-intervention (8 weeks))
研究者
Sahra Şirvan
MSc Physiotherapist
Istanbul University - Cerrahpasa