Motor Imagery on Children With DMD on Gait and Balance Functions

February 28, 2024 updated by: Gülsena Utku

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 8 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Physiotherapy and Rehabilitation Program
Control Group
Other: Physiotherapy and Rehabilitation Program

The program will be held for 8 weeks, 2 days a week, with 40-minute sessions. Relaxation phase: Progressive relaxation. Stretching phase: Stretching exercises for the muscles of the gastrocnemius, hamstrings, hip flexors, hip adductors Strengthening phase: Isometric strengthening exercises for the tibialis anterior, quadriceps, hip extensors, and hip abductors muscles.

Balance training phase: Two legs, one leg, balance with eyes open and eyes closed.

Weight-bearing phase: Weight transfer to the front, back, and sides using the balance board.

Other Names:
  • Control group
Experimental: Additional Motor Imagery Training to Physiotherapy and Rehabilitation Program
Intervention Group
Other: Physiotherapy and Rehabilitation Program

The program will be held for 8 weeks, 2 days a week, with 40-minute sessions. Relaxation phase: Progressive relaxation. Stretching phase: Stretching exercises for the muscles of the gastrocnemius, hamstrings, hip flexors, hip adductors Strengthening phase: Isometric strengthening exercises for the tibialis anterior, quadriceps, hip extensors, and hip abductors muscles.

Balance training phase: Two legs, one leg, balance with eyes open and eyes closed.

Weight-bearing phase: Weight transfer to the front, back, and sides using the balance board.

Other Names:
  • Control group
Other: Additional Motor Imagery Training to Physiotherapy and Rehabilitation Program
The program will be held for 8 weeks, 2 days a week, with 40-minute sessions. Relaxation phase, Stretching phase, Strengthening phase,Balance training phase and Weight-bearing phase. Additional to the Physiotherapy and Rehabilitation Program, the Additional Motor Imagery Training program will be carried out for 8 weeks, 2 days a week, in addition to the 40-minute physiotherapy and rehabilitation program, accompanied by 25-30 minutes of supervision. It will be conducted by the researcher on two non-consecutive days of the week, by making appropriate appointments for the participants. During the program, participants will be asked to be in a quiet room. Sessions will consist of 4 consecutive phases: video watching, relaxation, motor imagery, and return to the environment.
Other Names:
  • Intervention group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gait analysis1
Time Frame: one week before the intervention and one week after the intervention
Change from Baseline Stride length in meters
one week before the intervention and one week after the intervention
gait analysis2
Time Frame: one week before the intervention and one week after the intervention
Change from Baseline stride width in meters
one week before the intervention and one week after the intervention
gait analysis3
Time Frame: one week before the intervention and one week after the intervention
Change from Baseline Systolic cadence
one week before the intervention and one week after the intervention
gait analysis4
Time Frame: one week before the intervention and one week after the intervention
Change from Baseline walking speed in meters/second
one week before the intervention and one week after the intervention
balance
Time Frame: one week before the intervention and one week after the intervention
Change from Baseline Pediatric Balance Scale in grades 0-56 points
one week before the intervention and one week after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
muscle strength measurement
Time Frame: one week before the intervention and one week after the intervention
Strength measurements of lower extremity muscles
one week before the intervention and one week after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gülsena Utku

Investigators

  • Study Director: Arzu Razak Özdinçler, Prof, Biruni University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2022

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

October 20, 2022

First Submitted That Met QC Criteria

October 31, 2022

First Posted (Actual)

November 1, 2022

Study Record Updates

Last Update Posted (Estimated)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MI on DMD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe