Development and Investigation of the Effectiveness of a Gamified Mobile Physical Therapy Exercise Application for Children With Duchenne Muscular Dystrophy: A 6-Month Follow-Up Single-Blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 主要终点
- Six-Minute Walk Test (6MWT)
研究概览
简要总结
Duchenne Muscular Dystrophy (DMD) is a progressive neuromuscular disease that limits children's physical function, mobility, and participation in daily life. Regular physiotherapy and exercise are essential to slow functional decline; however, many children experience difficulties maintaining motivation and adherence to long-term exercise programs. Low adherence leads to reduced treatment benefit and faster loss of motor abilities.
This study aims to investigate whether a gamified mobile physiotherapy exercise program can improve participation, motivation, and physical outcomes in children with DMD. The mobile program includes personalized exercises designed by physiotherapists and occupational therapists, combined with game-based elements such as rewards, levels, feedback, and virtual achievements to enhance engagement. The program is delivered in addition to face-to-face physiotherapy.
A total of 46 boys aged 6-12 years with a confirmed diagnosis of DMD will be recruited and randomly assigned to either an intervention group or a control group. Both groups will attend an 8-week center-based physiotherapy program. The intervention group will additionally use the gamified mobile exercise application at home, while the control group will receive a standard home exercise program. Participants will be evaluated before treatment, after 8 weeks, and at 6-month follow-up.
The primary outcomes include physical function, endurance, and mobility. Secondary outcomes include psychosocial well-being, motivation, and therapy participation. The study intends to determine whether gamification-based telerehabilitation can increase adherence, preserve physical abilities, and support participation in children with DMD. If effective, this approach may offer a practical and accessible tool to support long-term rehabilitation needs in this population.
详细描述
Duchenne Muscular Dystrophy (DMD) is a progressive neuromuscular disorder that leads to loss of muscle strength, functional decline, reduced mobility, and limitations in participation. Early and ongoing physiotherapy is essential to slow functional deterioration, maintain mobility, and support participation in daily-life activities. Despite its importance, adherence to long-term exercise programs is frequently low among children with DMD due to fatigue, monotony, lack of feedback, limited motivation, and challenges related to time management and caregiver burden.
Gamification has emerged as a promising method to sustain motivation and engagement by integrating game-based elements such as challenges, levels, rewards, feedback, and achievement-based progression into non-game health contexts. Digital and mobile health solutions also provide an opportunity to deliver personalised and home-based rehabilitation, support remote follow-up, and increase continuity of care. However, evidence for gamified telerehabilitation specifically designed for DMD is limited, and most existing telerehabilitation programs lack systematic motivational components or long-term follow-up data.
This study evaluates a gamified mobile physiotherapy exercise program developed for children with DMD to increase motivation, participation, and adherence to home-based rehabilitation. The program includes personalised exercise tasks designed by physiotherapists and occupational therapists, and integrates gamification mechanisms to reinforce engagement. The intervention is delivered alongside an 8-week center-based physiotherapy program and followed for an additional 6 months to assess long-term adherence and carry-over effects.
A total of 46 boys aged 6-12 years with a confirmed diagnosis of DMD will be recruited and randomly assigned to an intervention group or a control group. Both groups receive an identical center-based physiotherapy program, whereas the intervention group additionally uses the mobile application at home. The control group receives standard home-exercise instructions. Assessments occur at baseline, post-intervention, and at a 6-month follow-up.
Primary outcomes focus on physical function, mobility, and endurance. Secondary outcomes include psychosocial well-being, motivation, and therapy participation. This study aims to determine whether a gamified telerehabilitation approach can enhance adherence, help preserve physical function, and support participation in children with DMD. If effective, this digital model may offer an accessible, motivating, and scalable strategy for long-term rehabilitation in pediatric neuromuscular disorders.
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
- Single (Outcomes Assessor)
盲法说明
Outcome assessors were blinded to group allocation to reduce assessment bias. Participants, caregivers, and treating clinicians were not blinded due to the nature of the intervention.
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male child aged 6 to 12 years with a confirmed diagnosis of Duchenne muscular dystrophy (DMD) based on specialist evaluation and genetic testing.
- •Vignos lower extremity classification stage 1 or
- •Brooke upper extremity functional classification at least stage
- •Score of 27 or higher on the Modified Mini-Mental Test.
- •Ability to walk independently for at least 6 minutes.
- •Receiving physiotherapy and rehabilitation for at least 8 sessions over a 1-month period.
- •Having regular access to the internet at home.
- •Parent(s) or legal guardian willing to allow the child to participate and able to read and sign the written informed consent form.
排除标准
- •Presence of any additional diagnosed neurological disorder other than, or in addition to, Duchenne muscular dystrophy.
- •History of any injury and/or surgery within the last 6 months.
- •Any cooperation or behavioral problem that prevents completion of the assessment procedures.
- •Difficulty in understanding or speaking Turkish.
研究组 & 干预措施
Gamified Mobile Physiotherapy + Center-Based Physiotherapy
Participants assigned to the intervention arm will receive center-based physiotherapy three times per week for 8 weeks (45-minute sessions), in combination with a gamified mobile physiotherapy exercise application to be performed at home. The mobile component includes personalised exercise tasks, real-time feedback, and progression-based digital features to support home exercise completion. Participants will be instructed to use the application in accordance with a structured schedule provided by the clinical team.
干预措施: Gamified Mobile Physiotherapy Exercise Application (Behavioral)
Standard Home Exercise + Center-Based Physiotherapy
Participants assigned to the control arm will receive center-based physiotherapy three times per week for 8 weeks (45-minute sessions), in combination with standard home exercise instructions provided by the clinical team. Home exercises are prescribed according to conventional physiotherapy protocols for Duchenne muscular dystrophy and are to be performed without digital support.
干预措施: Standard Home Exercise Instructions (Behavioral)
结局指标
主要结局
Six-Minute Walk Test (6MWT)
时间窗: Baseline, 8 weeks (post-intervention), and 6-month follow-up
Distance walked in six minutes to assess functional mobility and endurance in ambulatory children w
次要结局
- Modified Upper Extremity Performance Test(Baseline (Day 1), Post-intervention (8 weeks), and 6-month follow-up)
- Repetitive Upper and Lower Extremity Movement Counts(aseline (Day 2), Post-intervention (8 weeks), and 6-month follow-up)
- Single Breath Counting Test(Baseline (Day 2), Post-intervention (8 weeks), and 6-month follow-up)
- Pediatric Berg Balance Scale(Baseline (Day 2), Post-intervention (8 weeks), and 6-month follow-up)
- Four Square Step Test(Baseline (Day 2), Post-intervention (8 weeks), and 6-month follow-up)
- ACTIVLIM(Baseline (Day 1), Post-intervention (8 weeks), and 6-month follow-up)
- Children's Depression Scale(Baseline (Day 2) and Post-intervention (8 weeks))
- Motivation for Home Exercise (Visual Analog Scale)(Baseline (Day 2) and Post-intervention (8 weeks) and 6 months follow-up)
- Pediatric Participation Data Collection Tool(Baseline (Day 1) and Post-intervention (8 weeks))
研究者
Başak Çağla Arslan
Lecturer
Lokman Hekim University