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临床试验/NCT06402942
NCT06402942招募中不适用

Gamified Occupational Therapy for Adolescents With Duchenne Muscular Dystrophy

Başak Çağla Arslan1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
1
主要终点
Modified Mini Mental State Test

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
13 Years 至 18 Years(Child, Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Experimental group

Experimental

Gamified occupational therapy programme group

干预措施: Gamified occupational therapy programme (Other)

Control group

Other

Classic occupational therapy group

干预措施: Classic occupational therapy programme (Other)

结局指标

主要结局

Modified Mini Mental State Test

时间窗: before and after the eight-week intervention programs

The Pediatric Quality of Life Inventory 3.0 Neuromuscular Module

时间窗: before and after the eight-week intervention programs

Canadian Occupational Performance Measure

时间窗: before and after the eight-week intervention programs

Children's Depression Inventory

时间窗: 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.

Vignos lower extremity functional scale

时间窗: 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.

The Pediatric Quality of Life Inventory Multidimensional Fatigue Scale

时间窗: 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.

Demographic information form

时间窗: At the start of the evaluations

Brooke upper extremity functional classification scale

时间窗: 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 Numeric Rating Scale - Pain

时间窗: 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).

次要结局

未报告次要终点

研究者

发起方
Başak Çağla Arslan
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Başak Çağla Arslan

Lecturer

Lokman Hekim University

研究点 (1)

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