DMD and Gamified Physiotherapy

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Six-Minute Walk Test (6MWT) [Срок оценки: Baseline, 8 weeks (post-intervention), and 6-month follow-up]

Вторичные конечные точки (9)

• Modified Upper Extremity Performance Test [Срок оценки: Baseline (Day 1), Post-intervention (8 weeks), and 6-month follow-up]
• Repetitive Upper and Lower Extremity Movement Counts [Срок оценки: aseline (Day 2), Post-intervention (8 weeks), and 6-month follow-up]
• Single Breath Counting Test [Срок оценки: Baseline (Day 2), Post-intervention (8 weeks), and 6-month follow-up]
• Pediatric Berg Balance Scale [Срок оценки: Baseline (Day 2), Post-intervention (8 weeks), and 6-month follow-up]
• Four Square Step Test [Срок оценки: Baseline (Day 2), Post-intervention (8 weeks), and 6-month follow-up]
• ACTIVLIM [Срок оценки: Baseline (Day 1), Post-intervention (8 weeks), and 6-month follow-up]
• Children's Depression Scale [Срок оценки: Baseline (Day 2) and Post-intervention (8 weeks)]
• Motivation for Home Exercise (Visual Analog Scale) [Срок оценки: Baseline (Day 2) and Post-intervention (8 weeks) and 6 months follow-up]
• Pediatric Participation Data Collection Tool [Срок оценки: Baseline (Day 1) and Post-intervention (8 weeks)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07368400 · 125S143 · 125S143

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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