Clinical trial NCT05601986: Motor Imagery on Children With DMD on Gait and Balance Functions
Official title: Investigation of the Effect of Motor Imagery on Gait and Balance Functions in Children With Duchenne Muscular Dystrophy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Duchenne Muscular Dystrophy
Keywords: Gait
Balance
Duchenne Muscular Dystrophy
Lead sponsor: Halic University
Sponsor class: OTHER
First posted: 2022-11-01
Enrollment: 34
Sex: MALE
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: gait analysis1
timeFrame: one week before the intervention and one week after the intervention
measure: gait analysis2
timeFrame: one week before the intervention and one week after the intervention
measure: gait analysis3
timeFrame: one week before the intervention and one week after the intervention
measure: gait analysis4
timeFrame: one week before the intervention and one week after the intervention
measure: balance
timeFrame: one week before the intervention and one week after the intervention
Secondary outcomes:
measure: muscle strength measurement
timeFrame: one week before the intervention and one week after the intervention
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Biruni University
Study officials:
affiliation: Biruni University
name: Arzu Razak Özdinçler, Prof
role: STUDY_DIRECTOR
References: