Duchenne Muscular Dystrophy (DMD)Gamified DMDNCT07368400
DMD and Gamified Physiotherapy
A study testing Gamified Mobile Physiotherapy Exercise Application and Standard Home Exercise Instructions in people with Duchenne Muscular Dystrophy (DMD), run by Başak Çağla Arslan.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 12 years, men only
- Conditions the study is for
- Duchenne Muscular Dystrophy (DMD)
- What is being tested?
- Gamified Mobile Physiotherapy Exercise Application and Standard Home Exercise Instructions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 8 May 2026to 5 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Duchenne Muscular Dystrophy (DMD)
- Being tested
- Gamified Mobile Physiotherapy Exercise Application, Standard Home Exercise Instructions
- Keywords
- dmd, exercise, gamification
- Medical subject headings
- Muscular Dystrophy, Duchenne, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamified Mobile Physiotherapy Exercise ApplicationBehavioural
Also called Center-Based Physiotherapy (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.
Standard Home Exercise InstructionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard Home Exercise Instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-Minute Walk Test (6MWT)
Distance walked in six minutes to assess functional mobility and endurance in ambulatory children w
Measured: Baseline, 8 weeks (post-intervention), and 6-month follow-up
Secondary outcomes (9)
Modified Upper Extremity Performance Test
Functional upper extremity performance test quantifying task execution time and efficiency. Higher performance indicates better function.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 1) and Post-intervention (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start8 May 2026 (estimated)
- Primary completion21 Dec 2026 (estimated)
- Study completion5 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duchenne Muscular Dystrophy (DMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Başak Çağla Arslan
- Sponsor type
- Other government
- Collaborators
- Hacettepe University, Lokman Hekim University, Bezmialem Vakif University
- Responsible party
- Sponsor-investigator, Başak Çağla Arslan, Lokman Hekim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07368400
- Sponsor's protocol ID
- 125S143
- Other IDs
- 125S143
- Acronym
- Gamified DMD
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to pediatric privacy and identifiable rare disease population.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07368400
- Acronym / sponsor ID
- Gamified DMD / 125S143
- Conditions
- Duchenne Muscular Dystrophy (DMD)
- Keywords
- dmd, exercise, gamification
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Başak Çağla ArslanOther government
- Collaborators
- Hacettepe University, Lokman Hekim University, Bezmialem Vakif University
- Study start
- 8 May 2026 (estimated)
- Primary completion
- 21 Dec 2026 (estimated)
- Study completion
- 5 Jul 2028 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Gamified Mobile Physiotherapy + Center-Based Physiotherapy | Experimental | Behavioral: Gamified Mobile Physiotherapy Exercise ApplicationParticipants 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. |
| Standard Home Exercise + Center-Based Physiotherapy | Active comparator | Behavioral: Standard Home Exercise InstructionsParticipants 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gamified Mobile Physiotherapy Exercise ApplicationAlso: Center-Based Physiotherapy (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. | Behavioural | Gamified Mobile Physiotherapy + Center-Based Physiotherapy |
| Standard Home Exercise InstructionsConventional 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. | Behavioural | Standard Home Exercise + Center-Based Physiotherapy |
Primary outcome
Six-Minute Walk Test (6MWT)
Time frame: Baseline, 8 weeks (post-intervention), and 6-month follow-up
Distance walked in six minutes to assess functional mobility and endurance in ambulatory children w
9 secondary outcomes
Modified Upper Extremity Performance Test
Time frame: Baseline (Day 1), Post-intervention (8 weeks), and 6-month follow-up
Repetitive Upper and Lower Extremity Movement Counts
Time frame: aseline (Day 2), Post-intervention (8 weeks), and 6-month follow-up
Single Breath Counting Test
Time frame: Baseline (Day 2), Post-intervention (8 weeks), and 6-month follow-up
Pediatric Berg Balance Scale
Time frame: Baseline (Day 2), Post-intervention (8 weeks), and 6-month follow-up
Four Square Step Test
Time frame: Baseline (Day 2), Post-intervention (8 weeks), and 6-month follow-up
ACTIVLIM
Time frame: Baseline (Day 1), Post-intervention (8 weeks), and 6-month follow-up
Children's Depression Scale
Time frame: Baseline (Day 2) and Post-intervention (8 weeks)
Motivation for Home Exercise (Visual Analog Scale)
Time frame: Baseline (Day 2) and Post-intervention (8 weeks) and 6 months follow-up
Pediatric Participation Data Collection Tool
Time frame: Baseline (Day 1) and Post-intervention (8 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No. Due to pediatric privacy and identifiable rare disease population.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Gamified Mobile Physiotherapy Exercise Application and Standard Home Exercise Instructions in people with Duchenne Muscular Dystrophy (DMD), run by Başak Çağla Arslan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Başak Çağla Arslan, MSc (+904448548, ptbasakc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six-Minute Walk Test (6MWT) (time frame: Baseline, 8 weeks (post-intervention), and 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.