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临床试验/NCT05601986
NCT05601986招募中不适用

Investigation of the Effect of Motor Imagery on Gait and Balance Functions in Children With Duchenne Muscular Dystrophy

Gülsena Utku2 个研究点 分布在 2 个国家目标入组 34 人开始时间: 2022年12月16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
34
试验地点
2
主要终点
gait analysis3

研究概览

简要总结

The most common muscular dystrophy among pediatric neuromuscular diseases is Duchenne Muscular Dystrophy (DMD). There is no consensus on a standardized physiotherapy and rehabilitation program or exercise prescription in DMD. Motor imagery (MI) is defined as visualizing motor activities in one's mind without performing any movement. There are studies examining the effectiveness of motor imagery in stroke, cerebral palsy, Parkinson's, peripheral facial paralysis, and phantom pain. This study is aimed to examine the effect of motor imagery on gait and balance functions in children with Duchenne Muscular Dystrophy. Boys residing in Istanbul Turkey, between the ages of 5 and 12, with a diagnosis of DMD who have not lost their ability to ambulate independently will be included in the study. The included individuals will be divided into two groups due to randomization: Group A (Control Group Physiotherapy and Rehabilitation Program) and Group B (Additional Motor Imagery Training to Intervention Group Physiotherapy and Rehabilitation Program). While the physiotherapy and rehabilitation program is applied to the participants in Group A with 40-minute sessions on 2 non-consecutive days of the week for 8 weeks, the participants in Group B will receive an additional 25-30-minute motor imagery program to the physiotherapy and rehabilitation program. Participants were tested with Kinovea Gait Analysis, Timed Up and Go Test, 2 Minute Walking Test, Motor Function Rating Scale for Neuromuscular Diseases, timed performance tests, Pediatric Berg Balance Scale, Pediatric Fear of Fall Questionnaire (Ped-FOF) before and after the program. will be evaluated later. IBM SPSS (Statistical Package for Social Sciences) statistical program version 22.0 will be used for statistical analysis. The conformity of the variables to the normal distribution will be determined by the "Shapiro-Wilk Test". If the variables show normal distribution, the variation within the group will be analyzed with the "Paired Sample T Test", if not, the "Wilcoxon Test" will be analyzed. In the comparison between groups, if the variables show normal distribution, it will be done with the "Independent T Test" in independent groups and the "Mann Whitney U Test" if they do not show normal distribution. Categorical data distributions will be evaluated with the "Chi-square test". In all analyses, p<0.05 will be considered statistically significant.

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
Double (Participant, Care Provider)

入排标准

年龄范围
5 Years 至 12 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • Have a physician-prescribed diagnosis of Duchenne Muscular Dystrophy
  • Not having any injury or surgical operation in the last 6 months
  • Being between Levels 1-5 (children who continue to ambulate independently) according to - Brooke Lower Extremity Functional Classification Modified Mini-Mental Test score >27
  • Having the level of cooperation to follow the physiotherapist's instructions
  • Volunteering to participate in research

排除标准

  • Having severe contractures that interfere with functional activities
  • Level 6-10 (children not capable of independent ambulation) according to the Brooke Lower Extremity Functional Classification
  • To receive applications in addition to the physiotherapy and rehabilitation program or different from the physiotherapy and rehabilitation program

研究组 & 干预措施

Physiotherapy and Rehabilitation Program

Other

Control Group

干预措施: Physiotherapy and Rehabilitation Program (Other)

Additional Motor Imagery Training to Physiotherapy and Rehabilitation Program

Experimental

Intervention Group

干预措施: Additional Motor Imagery Training to Physiotherapy and Rehabilitation Program (Other)

Additional Motor Imagery Training to Physiotherapy and Rehabilitation Program

Experimental

Intervention Group

干预措施: Physiotherapy and Rehabilitation Program (Other)

结局指标

主要结局

gait analysis3

时间窗: one week before the intervention and one week after the intervention

Change from Baseline Systolic cadence

gait analysis1

时间窗: one week before the intervention and one week after the intervention

Change from Baseline Stride length in meters

gait analysis2

时间窗: one week before the intervention and one week after the intervention

Change from Baseline stride width in meters

gait analysis4

时间窗: one week before the intervention and one week after the intervention

Change from Baseline walking speed in meters/second

balance

时间窗: one week before the intervention and one week after the intervention

Change from Baseline Pediatric Balance Scale in grades 0-56 points

次要结局

  • muscle strength measurement(one week before the intervention and one week after the intervention)

研究者

发起方
Gülsena Utku
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gülsena Utku

Principal Investigator

Halic University

研究点 (2)

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