Duchenne Muscular DystrophyDMDNCT06402942
Gamified Occupational Therapy for Adolescents With Duchenne Muscular Dystrophy
A study testing Gamified occupational therapy programme and Classic occupational therapy programme in people with Duchenne Muscular Dystrophy and Gamification, run by Başak Çağla Arslan at 1 site in Turkey (Türkiye).
Trial summary
This research aims to improve the quality of life, occupational performance, occupational satisfaction and emotional health of young people with Duchenne muscular dystrophy compared to the classical occupational therapy program. Read more about this study
- Who is it for?
- Ages 13 to 18 years, men only
- Conditions the study is for
- Duchenne Muscular Dystrophy, Gamification, Occupational Therapy
- What is being tested?
- Gamified occupational therapy programme and Classic occupational therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 8 Dec 2026
- 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 13 to 18 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Being diagnosed with Duchenne muscular dystrophy
- To be literate in Turkish
- To have scored 27 points or more on the Modified Mini Mental Test
- Having a computer, tablet and internet connection
- Volunteering to participate in the study by their parents and reading and signing the informed consent form
Who cannot join
- Having a neurological disease other than Duchenne muscular dystrophy and/or another diagnosed neurological disease accompanying Duchenne muscular dystrophy
- Having a cooperation problem that prevents completing the assessments for any reason
- Difficulty understanding and speaking the Turkish language
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Lokman Hekim University
Ankara, 06510
Başak Çağla Arslan, Master's Degree
About this study
This research aims to improve the quality of life, occupational performance, occupational satisfaction and emotional health of young people with Duchenne muscular dystrophy compared to the classical occupational therapy program. The findings are planned to shed light on the development of new and effective strategies in the rehabilitation of adolescents with Duchenne muscular dystrophy.
- Being tested
- Gamified occupational therapy programme, Classic occupational therapy programme
- Medical subject headings
- Muscular Dystrophy, Duchenne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamified occupational therapy programmeOther
Gamified occupational therapy program for the experimental group and classical occupational therapy program for the control group, which will be applied to both groups for eight weeks
Classic occupational therapy programmeOther
Gamified occupational therapy program for the experimental group and classical occupational therapy program for the control group, which will be applied to both groups for eight weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Gamified occupational therapy programme group Receives: Other: Gamified occupational therapy programme |
| Control group | Other | Classic occupational therapy group Receives: Other: Classic occupational therapy programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic information form
Measured: At the start of the evaluations
Modified Mini Mental State Test
Measured: before and after the eight-week intervention programs
Vignos lower extremity functional scale
This scale was developed to assess the level of ambulation in neuromuscular diseases and consists of 10 stages. In this scale, the ambulation level of the person decreases from the first stage to the tenth stage.
Measured: before and after the eight-week intervention programs
Brooke upper extremity functional classification scale
This scale was developed to assess the functional levels of the upper extremity in neuromuscular diseases and consists of 6 stages. In this scale, progression from the first stage to the sixth stage indicates a decrease in the functionality of the upper extremity.
Measured: before and after the eight-week intervention programs
The Pediatric Quality of Life Inventory 3.0 Neuromuscular Module
Measured: before and after the eight-week intervention programs
Canadian Occupational Performance Measure
Measured: before and after the eight-week intervention programs
Children's Depression Inventory
Consisting of 27 items and using a 3-point Likert-type scale, this scale assesses the depression levels of children between the ages of 6-17. The total score of the scale, which measures the emotional state in the last 2 weeks, is 54 and the severity of depression increases as the total score increases. The cut-off value of the scale was determined as 19 points.
Measured: before and after the eight-week intervention programs
The Pediatric Quality of Life Inventory Multidimensional Fatigue Scale
This scale consists of 18 items and 3 subsections: general fatigue (6 items), fatigue during sleep/rest (6 items) and cognitive fatigue (6 items). Separate scores can be calculated for each subsection and the total score is obtained by summing the scores obtained from these sections. High scores indicate low fatigue.
Measured: before and after the eight-week intervention programs
The Numeric Rating Scale - Pain
This scale uses a 10-centimeter line. The left beginning of the line represents "no pain" (0 points) and the end of the line represents "excruciating pain" (10 points).
Measured: before and after the eight-week intervention programs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start1 May 2025
- Primary completion21 Aug 2026 (estimated)
- Study completion8 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Duchenne Muscular DystrophyStudies 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
- Randomised control trial
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Başak Çağla Arslan
- Sponsor type
- Other government
- Collaborators
- Hacettepe University
- Responsible party
- Sponsor-investigator, Başak Çağla Arslan, Lokman Hekim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402942
- Sponsor's protocol ID
- LHU20241004
- Other IDs
- LHÜ
- Acronym
- DMD
- Status last verified
- Jan 2026
- First submitted
- 3 May 2024
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arslan BC, Sahin S. Gamified occupational therapy program for adolescents with Duchenne muscular dystrophy: A study protocol for randomized controlled trial. Assist Technol. 2026 Jul 30:1-9. doi: 10.1080/10400435.2026.2709162. Online ahead of print.
PubMed 42530145
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
- Gamified Occupational Therapy for Adolescents With Duchenne Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT06402942
- Acronym / sponsor ID
- DMD / LHU20241004
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Başak Çağla ArslanOther government
- Collaborators
- Hacettepe University
- Study start
- 1 May 2025 (actual)
- Primary completion
- 21 Aug 2026 (estimated)
- Study completion
- 8 Dec 2026 (estimated)
- First posted
- 7 May 2024 (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.
This research aims to improve the quality of life, occupational performance, occupational satisfaction and emotional health of young people with Duchenne muscular dystrophy compared to the classical occupational therapy program. The findings are planned to shed light on the development of new and effective strategies in the rehabilitation of adolescents with Duchenne muscular dystrophy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised control trial
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Gamified occupational therapy programmeGamified occupational therapy programme group |
| Control group | Other | Other: Classic occupational therapy programmeClassic occupational therapy group |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Being diagnosed with Duchenne muscular dystrophy
- To be literate in Turkish
- To have scored 27 points or more on the Modified Mini Mental Test
- Having a computer, tablet and internet connection
- Volunteering to participate in the study by their parents and reading and signing the informed consent form
Key exclusion criteria (3 listed)
- Having a neurological disease other than Duchenne muscular dystrophy and/or another diagnosed neurological disease accompanying Duchenne muscular dystrophy
- Having a cooperation problem that prevents completing the assessments for any reason
- Difficulty understanding and speaking the Turkish language
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 occupational therapy programmeGamified occupational therapy program for the experimental group and classical occupational therapy program for the control group, which will be applied to both groups for eight weeks | Other | Experimental group |
| Classic occupational therapy programmeGamified occupational therapy program for the experimental group and classical occupational therapy program for the control group, which will be applied to both groups for eight weeks | Other | Control group |
Primary outcome
Demographic information form
Time frame: At the start of the evaluations
Modified Mini Mental State Test
Time frame: before and after the eight-week intervention programs
Vignos lower extremity functional scale
Time frame: before and after the eight-week intervention programs
This scale was developed to assess the level of ambulation in neuromuscular diseases and consists of 10 stages. In this scale, the ambulation level of the person decreases from the first stage to the tenth stage.
Brooke upper extremity functional classification scale
Time frame: before and after the eight-week intervention programs
This scale was developed to assess the functional levels of the upper extremity in neuromuscular diseases and consists of 6 stages. In this scale, progression from the first stage to the sixth stage indicates a decrease in the functionality of the upper extremity.
The Pediatric Quality of Life Inventory 3.0 Neuromuscular Module
Time frame: before and after the eight-week intervention programs
Canadian Occupational Performance Measure
Time frame: before and after the eight-week intervention programs
Children's Depression Inventory
Time frame: before and after the eight-week intervention programs
Consisting of 27 items and using a 3-point Likert-type scale, this scale assesses the depression levels of children between the ages of 6-17. The total score of the scale, which measures the emotional state in the last 2 weeks, is 54 and the severity of depression increases as the total score increases. The cut-off value of the scale was determined as 19 points.
The Pediatric Quality of Life Inventory Multidimensional Fatigue Scale
Time frame: before and after the eight-week intervention programs
This scale consists of 18 items and 3 subsections: general fatigue (6 items), fatigue during sleep/rest (6 items) and cognitive fatigue (6 items). Separate scores can be calculated for each subsection and the total score is obtained by summing the scores obtained from these sections. High scores indicate low fatigue.
The Numeric Rating Scale - Pain
Time frame: before and after the eight-week intervention programs
This scale uses a 10-centimeter line. The left beginning of the line represents "no pain" (0 points) and the end of the line represents "excruciating pain" (10 points).
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.
- Derived from this study: PubMed 42530145Arslan BC, Sahin S. Gamified occupational therapy program for adolescents with Duchenne muscular dystrophy: A study protocol for randomized controlled trial. Assist Technol. 2026 Jul 30:1-9. doi: 10.1080/10400435.2026.2709162. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gamified occupational therapy programme and Classic occupational therapy programme in people with Duchenne Muscular Dystrophy and Gamification, run by Başak Çağla Arslan at 1 site in Turkey (Türkiye).
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 5 inclusion and 3 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: looking for participants now, 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.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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, Master Degree (4448548, ptbasakc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic information form (time frame: At the start of the evaluations). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06402942, which also lists 1 linked publication.
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.