DMD and Gamified Physiotherapy (Gamified DMD)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Duchenne Muscular Dystrophy (DMD)
• Intervention / Treatment: Behavioral: Gamified Mobile Physiotherapy Exercise Application; Behavioral: Standard Home Exercise Instructions

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.

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Başak Çağla Arslan, MSc; Phone Number: +904448548; Email: ptbasakc@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Gamified 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.; Other Names: Center-Based Physiotherapy (Behavioral)
Active Comparator: 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.	Behavioral: Standard 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Başak Çağla Arslan
• Collaborators: Hacettepe University; Bezmialem Vakif University; Lokman Hekim University

Study record dates

Study Major Dates

• Study Start (Estimated): May 8, 2026
• Primary Completion (Estimated): December 21, 2026
• Study Completion (Estimated): July 5, 2028

Study Registration Dates

• First Submitted: January 18, 2026
• First Submitted That Met QC Criteria: January 18, 2026
• First Posted (Actual): January 26, 2026

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 24, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: exercise; gamification; dmd
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Muscular Disorders, Atrophic; Muscular Dystrophies; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior; Muscular Dystrophy, Duchenne; Motor Activity
• Other Study ID Numbers: 125S143 (Other Grant/Funding Number: TÜBİTAK)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to pediatric privacy and identifiable rare disease population.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No