Gamified Occupational Therapy for Adolescents With Duchenne Muscular Dystrophy

Duchenne Muscular Dystrophy Clinical Trial

— DMD  

Official title:

Gamified Occupational Therapy for Adolescents With Duchenne Muscular Dystrophy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06402942
• Other study ID #: LHU20241004
• Secondary ID: LHÜ
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: May 8, 2025

Study information

• Verified date: May 2024
• Source: Lokman Hekim Üniversitesi
• Contact: Basak Çagla Arslan, Master Degree
• Phone: 4448548
• Email: ptbasakc[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The findings are planned to shed light on the development of new and effective strategies in the rehabilitation of adolescents with Duchenne muscular dystrophy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 8, 2025
• Est. primary completion date: March 21, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 13 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Duchenne Muscular Dystrophy
• Gamification
• Muscular Dystrophies
• Muscular Dystrophy, Duchenne
• Occupational Therapy

Intervention

Other:
• Gamified occupational therapy programme
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 programme
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

Locations

Country	Name	City	State
Turkey	Lokman Hekim University	Ankara

Sponsors (2)

Lead Sponsor	Collaborator
Basak Çagla Arslan	Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demographic information form		At the start of the evaluations
Primary	Modified Mini Mental State Test		before and after the eight-week intervention programs
Primary	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.	before and after the eight-week intervention programs
Primary	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.	before and after the eight-week intervention programs
Primary	The Pediatric Quality of Life Inventory 3.0 Neuromuscular Module		before and after the eight-week intervention programs
Primary	Canadian Occupational Performance Measure		before and after the eight-week intervention programs
Primary	The Hospital Anxiety and Depression Scale (HADS)	Of the total 14 items in the scale, odd-numbered items measure anxiety and even-numbered items measure depression. The scores to be obtained from the sub-dimensions of the scale are between 0-21. The measurement results of the sub-dimensions indicate clinical distress with a total score of 7.5 for anxiety and a total score of 5.5 for depression. For each subscale, there are recommended cut-off scores of 8-10 points for mild severity, 11-15 points for moderate severity and 16 points and above for severe severity.	before and after the eight-week intervention programs
Primary	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.	before and after the eight-week intervention programs
Primary	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).	before and after the eight-week intervention programs