DMD and Gamified Physiotherapy

NCT07368400 | Not Yet Recruiting DMC

• 1 other identifier: 125S143
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Duchenne Muscular Dystrophy (DMD)

Keywords

dmd; exercise; gamification

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

Study Arms (2)

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.

Behavioral: Gamified Mobile Physiotherapy Exercise Application

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.

Behavioral: Standard Home Exercise Instructions

Interventions

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.

Also known as: Center-Based Physiotherapy (Behavioral)

Gamified Mobile Physiotherapy + Center-Based Physiotherapy

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.

Standard Home Exercise + Center-Based Physiotherapy

Eligibility Criteria

• Age: 6 Years - 12 Years
• Gender Eligibility Details: 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.
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lokman Hekim University: collaborator
• Bezmialem Vakif University: collaborator
• Başak Çağla Arslan: lead
• Hacettepe University: collaborator

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne; Motor Activity

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior

Central Study Contacts

Başak Çağla Arslan, MSc

CONTACT

+904448548; ptbasakc@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: January 26, 2026
• Study Start: May 8, 2026
• Primary Completion (Estimated): December 21, 2026
• Study Completion (Estimated): July 5, 2028
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share