Gamified Occupational Therapy for Adolescents With Duchenne Muscular Dystrophy

NCT06402942 | Recruiting

• 2 other identifiers: LHU20241004LHÜ
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Occupational Therapy; Gamification; Duchenne Muscular Dystrophy

Outcome Measures

Primary Outcomes (9)

• Demographic information form

  At the start of the evaluations

• Modified Mini Mental State Test

  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.

  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.

  before and after the eight-week intervention programs

• The Pediatric Quality of Life Inventory 3.0 Neuromuscular Module

  before and after the eight-week intervention programs

• Canadian Occupational Performance Measure

  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.

  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.

  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).

  before and after the eight-week intervention programs

Study Arms (2)

Experimental group

EXPERIMENTAL

Gamified occupational therapy programme group

Other: Gamified occupational therapy programme

Control group

OTHER

Classic occupational therapy group

Other: Classic occupational therapy programme

Interventions

Classic occupational therapy programme OTHER

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

Control group

Gamified occupational therapy programme OTHER

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

Experimental group

Eligibility Criteria

• Age: 13 Years - 18 Years
• Gender Eligibility Details: Duchenne muscular dystrophy occurs mostly in boys and very rarely in girls. Girls are usually carriers.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Başak Çağla Arslan: lead
• Hacettepe University: collaborator

Study Sites (1)

Lokman Hekim University

Ankara, 06510, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Başak Çağla Arslan, Master Degree

CONTACT

4448548; ptbasakc@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Model Details: Randomised control trial

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 7, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): August 21, 2026
• Study Completion (Estimated): December 8, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)