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临床试验/NCT05575648
NCT05575648已完成不适用

Investigation of Dual Task Performance in Children With Duchenne Muscular Dystrophy

Hacettepe University2 个研究点 分布在 2 个国家目标入组 94 人开始时间: 2022年9月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
94
试验地点
2
主要终点
Dual task performance- 10 meter walk test with motor task

研究概览

简要总结

This study was planned to determine the effects of the dual-task performance of children with DMD with motor dysfunction and varying degrees of cognitive impairment compared to their healthy peers, to compare the dual-task performance of children with different functional levels, and to determine the relationship between parameters that may affect dual-task performance.

详细描述

Children who are at least 6 years old and who can walk 10 meters independently, whose Duchenne's muscular dystrophy (DMD) diagnosis has been confirmed as a result of genetic testing, will be included in the study. To determine dual-task performance, the 10-meter Walk Test will be performed with additional motor and cognitive tasks. Functional level (Brooke Lower Extremity Functional Classification), ambulation level (North Star Ambulation Rating), muscular performance and functions (6 Minute Walk Test), balance (Pediatric Berg Balance Scale and four square step test), fear of falling (Fear of Falling Questionnaire), gait (Gait in DMD Assessment Scale, Gait Quality and Independence Classification Scale in DMD, and Functional Evaluation Scale for Duchenne Muscular Dystrophy-Gait Domain (FES-DMD-GD)), cognitive level (Modified Mini-Mental State Test (MMDT)), independence and activity limitation (Pediatric Functional Independence Measure (WeeFIM) and ACTIVLIM), quality of life (The Pediatric Quality of Life Inventory (PedsQL)-Neuromuscular Module Turkish version PedsQL-3.0 Neuromuscular Module) will be evaluated.

研究设计

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

入排标准

年龄范围
6 Years 至 —(Child, Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Having been diagnosed with DMD by a pediatric neurologist,
  • Must be at least 6 years old and have the ability to walk 10 meters independently,
  • Being able to cooperate with the instructions given by the physiotherapist,
  • Not having undergone surgery in the last 6 months and not having any injuries,

排除标准

  • Failure to cooperate with the physiotherapist who made the evaluations,
  • Have had any injury and/or surgery in the last 6 months,
  • Children without consent will not be included.

研究组 & 干预措施

Duchenne Muscular Dystrophy

Other

Children who have been diagnosed with Duchenne Muscular Dystrophy.

干预措施: 10 meter walk test (Other)

Healthy Subjects

Active Comparator

Children who have a normal motor and cognitive development.

干预措施: 10 meter walk test (Other)

结局指标

主要结局

Dual task performance- 10 meter walk test with motor task

时间窗: only baseline

The time is measured after 10 meter walk with a motor task completed

Dual task performance- 10 meter walk test

时间窗: only baseline

The time is measured after 10 meter walk completed

Dual task performance- 10 meter walk test with cognitive task

时间窗: only baseline

The time is measured after 10 meter walk with a cognitive (memory and mental) task completed

次要结局

  • Fear of falling - Pediatric Fear of Falling Questionnaire(only baseline)
  • Ambulation level- North star ambulatory assessment(only baseline)
  • Functional level- Brooke Lower Extremity Functional Classification(only baseline)
  • Performance- 6 minutes walk test(only baseline)
  • Balance - Pediatric berg balance scale(only baseline)
  • Balance - Four square step test(only baseline)
  • Fall frequency(only baseline)
  • Gait - Gait Evaluation Scale in Duchenne Muscular Dystrpohy(only baseline)
  • Gait - Gait Classification Scale in Duchenne Muscular Dystrpohy(only baseline)
  • Gait - Functional Evaluation Scale for Duchenne Muscular Dystrophy-Gait Domain(only baseline)
  • Cognitive level - Modified Mini Mental Test(only baseline)
  • Activity of daily living - The Functional Independence Measure for Children (WeeFIM)(only baseline)
  • Activity of daily living - ACTIVLIM(only baseline)
  • Quality of life - The Pediatric Quality of Life Inventory (PedsQL)-Neuromuscular Module Turkish version PedsQL-3.0(only baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Büşra Kayabınar

PhD candidate

Hacettepe University

研究点 (2)

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