- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06402942
Gamified Occupational Therapy for Adolescents With Duchenne Muscular Dystrophy (DMD)
January 24, 2026 updated by: Başak Çağla Arslan
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 Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Başak Çağla Arslan, Master Degree
- Phone Number: 4448548
- Email: ptbasakc@gmail.com
Study Locations
-
-
-
Ankara, Turkey (Türkiye), 06510
- Recruiting
- Lokman Hekim University
-
Contact:
- Başak Çağla Arslan, Master's Degree
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
Gamified occupational therapy programme group
|
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
|
|
Other: Control group
Classic occupational therapy group
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Demographic information form
Time Frame: At the start of the evaluations
|
At the start of the evaluations
|
|
|
Modified Mini Mental State Test
Time Frame: before and after the eight-week intervention programs
|
before and after the eight-week intervention programs
|
|
|
The Pediatric Quality of Life Inventory 3.0 Neuromuscular Module
Time Frame: before and after the eight-week intervention programs
|
before and after the eight-week intervention programs
|
|
|
Canadian Occupational Performance Measure
Time Frame: before and after the eight-week intervention programs
|
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.
|
before and after the eight-week intervention programs
|
|
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.
|
before and after the eight-week intervention programs
|
|
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.
|
before and after the eight-week intervention programs
|
|
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).
|
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.
|
before and after the eight-week intervention programs
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2025
Primary Completion (Estimated)
August 21, 2026
Study Completion (Estimated)
December 8, 2026
Study Registration Dates
First Submitted
May 3, 2024
First Submitted That Met QC Criteria
May 3, 2024
First Posted (Actual)
May 7, 2024
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- LHU20241004
- LHÜ (Other Identifier: LHÜ)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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