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| ID | Type | Description | Link |
|---|---|---|---|
| 125S143 | Other Grant/Funding Number | TÜBİTAK |
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| Name | Class |
|---|---|
| Hacettepe University | OTHER |
| Lokman Hekim University | OTHER_GOV |
| Bezmialem Vakif University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gamified Mobile Physiotherapy + Center-Based Physiotherapy | Experimental | 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. |
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| Standard Home Exercise + Center-Based Physiotherapy | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gamified Mobile Physiotherapy Exercise Application | Behavioral | A mobile gamified exercise program designed for children with Duchenne muscular dystrophy. The program includes personalised exercise tasks, progression-based game features, and feedback to support home-based physiotherapy participation. |
| Measure | Description | Time Frame |
|---|---|---|
| Six-Minute Walk Test (6MWT) | Distance walked in six minutes to assess functional mobility and endurance in ambulatory children w | Baseline, 8 weeks (post-intervention), and 6-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Upper Extremity Performance Test | Functional upper extremity performance test quantifying task execution time and efficiency. Higher performance indicates better function. | Baseline (Day 1), Post-intervention (8 weeks), and 6-month follow-up |
| Repetitive Upper and Lower Extremity Movement Counts |
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Inclusion Criteria:
Exclusion Criteria:
Duchenne muscular dystrophy is an X-linked recessive neuromuscular disorder that predominantly affects males. Therefore, only male children with a confirmed diagnosis of DMD are eligible to participate in this study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Başak Çağla Arslan, MSc | Contact | +904448548 | ptbasakc@gmail.com |
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Due to pediatric privacy and identifiable rare disease population.
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| ID | Term |
|---|---|
| D020388 | Muscular Dystrophy, Duchenne |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009136 | Muscular Dystrophies |
| D020966 | Muscular Disorders, Atrophic |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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This study uses a parallel assignment model in which participants are randomly allocated to either an intervention group or a control group. The intervention group receives a gamified mobile physiotherapy exercise program in addition to center-based physiotherapy, while the control group receives the same center-based physiotherapy plus standard home exercise instructions. Since the effects of the intervention are expected to be unidirectional and may not be reversible in a short duration, a parallel model was chosen over a crossover design. The groups are followed simultaneously and do not cross over during the study. The model allows comparison of short-term treatment effects and longer-term adherence outcomes.
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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.
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| Standard Home Exercise Instructions | Behavioral | Conventional physiotherapy home exercise instructions provided as written and verbal guidance without digital or gamified components. Exercises are aligned with standard clinical practice for Duchenne muscular dystrophy. |
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Number of repetitions completed within a standardized time period to assess muscle endurance and functional movement capacity. Higher counts indicate better performance. |
| aseline (Day 2), Post-intervention (8 weeks), and 6-month follow-up |
| Single Breath Counting Test | Number counted in a single exhalation to assess respiratory function and breath support. Higher values indicate better respiratory capacity. | Baseline (Day 2), Post-intervention (8 weeks), and 6-month follow-up |
| Pediatric Berg Balance Scale | Standardized pediatric balance assessment (0-56 range). Higher scores indicate better balance. | Baseline (Day 2), Post-intervention (8 weeks), and 6-month follow-up |
| Four Square Step Test | Dynamic balance test measuring time required to sequentially step into four quadrants. Lower times indicate better performance. | Baseline (Day 2), Post-intervention (8 weeks), and 6-month follow-up |
| ACTIVLIM | Participation and activity limitation questionnaire assessing perceived difficulty in daily activities. Higher scores reflect lower activity limitation. | Baseline (Day 1), Post-intervention (8 weeks), and 6-month follow-up |
| Children's Depression Scale | Validated pediatric scale assessing depressive symptoms. Higher scores indicate greater depressive symptomatology. | Baseline (Day 2) and Post-intervention (8 weeks) |
| Motivation for Home Exercise (Visual Analog Scale) | Motivation rated on a 10 cm visual analog scale. Higher scores reflect higher motivation for home-based exercise participation. | Baseline (Day 2) and Post-intervention (8 weeks) and 6 months follow-up |
| Pediatric Participation Data Collection Tool | Structured instrument assessing participation in daily-life activities from pediatric perspective. Higher scores indicate better participation. | Baseline (Day 1) and Post-intervention (8 weeks) |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D040181 | Genetic Diseases, X-Linked |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001519 | Behavior |