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DMD and Gamified Physiotherapy

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07368400
Acronym
Gamified DMD
Enrollment
46
Registered
2026-01-26
Start date
2026-05-08
Completion date
2028-07-05
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Duchenne Muscular Dystrophy (DMD)

Keywords

dmd, exercise, gamification

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALGamified Mobile Physiotherapy Exercise Application

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.

BEHAVIORALStandard Home Exercise Instructions

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.

Sponsors

Başak Çağla Arslan
Lead SponsorOTHER_GOV
Hacettepe University
CollaboratorOTHER
Lokman Hekim University
CollaboratorOTHER_GOV
Bezmialem Vakif University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
MALE
Age
6 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

* 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 2. * Brooke upper extremity functional classification at least stage 5. * 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Six-Minute Walk Test (6MWT)Baseline, 8 weeks (post-intervention), and 6-month follow-upDistance walked in six minutes to assess functional mobility and endurance in ambulatory children w

Secondary

MeasureTime frameDescription
Modified Upper Extremity Performance TestBaseline (Day 1), Post-intervention (8 weeks), and 6-month follow-upFunctional upper extremity performance test quantifying task execution time and efficiency. Higher performance indicates better function.
Repetitive Upper and Lower Extremity Movement Countsaseline (Day 2), Post-intervention (8 weeks), and 6-month follow-upNumber of repetitions completed within a standardized time period to assess muscle endurance and functional movement capacity. Higher counts indicate better performance.
Single Breath Counting TestBaseline (Day 2), Post-intervention (8 weeks), and 6-month follow-upNumber counted in a single exhalation to assess respiratory function and breath support. Higher values indicate better respiratory capacity.
Pediatric Berg Balance ScaleBaseline (Day 2), Post-intervention (8 weeks), and 6-month follow-upStandardized pediatric balance assessment (0-56 range). Higher scores indicate better balance.
Four Square Step TestBaseline (Day 2), Post-intervention (8 weeks), and 6-month follow-upDynamic balance test measuring time required to sequentially step into four quadrants. Lower times indicate better performance.
ACTIVLIMBaseline (Day 1), Post-intervention (8 weeks), and 6-month follow-upParticipation and activity limitation questionnaire assessing perceived difficulty in daily activities. Higher scores reflect lower activity limitation.
Children's Depression ScaleBaseline (Day 2) and Post-intervention (8 weeks)Validated pediatric scale assessing depressive symptoms. Higher scores indicate greater depressive symptomatology.
Motivation for Home Exercise (Visual Analog Scale)Baseline (Day 2) and Post-intervention (8 weeks) and 6 months follow-upMotivation rated on a 10 cm visual analog scale. Higher scores reflect higher motivation for home-based exercise participation.
Pediatric Participation Data Collection ToolBaseline (Day 1) and Post-intervention (8 weeks)Structured instrument assessing participation in daily-life activities from pediatric perspective. Higher scores indicate better participation.

Contacts

CONTACTBaşak Çağla Arslan, MSc
ptbasakc@gmail.com+904448548

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026