Motor Imagery on Children With DMD on Gait and Balance Functions

NCT ID: NCT05601986

Last Updated: 2024-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-16

Study Completion Date

2024-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Duchenne Muscular Dystrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Physiotherapy and Rehabilitation Program

Control Group

Group Type OTHER

Physiotherapy and Rehabilitation Program

Intervention Type OTHER

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.

Additional Motor Imagery Training to Physiotherapy and Rehabilitation Program

Intervention Group

Group Type EXPERIMENTAL

Physiotherapy and Rehabilitation Program

Intervention Type OTHER

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.

Additional Motor Imagery Training to Physiotherapy and Rehabilitation Program

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Control group Intervention group

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Gülsena Utku

OTHER

Sponsor Role lead

Responsible Party

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Gülsena Utku

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Arzu Razak Özdinçler, Prof

Role: STUDY_DIRECTOR

Biruni University

Locations

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Biruni University

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Gülsena Utku Umut

Role: CONTACT

+905370664646

Facility Contacts

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Gülsena Utku Umut

Role: primary

+905370664646

Other Identifiers

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MI on DMD

Identifier Type: -

Identifier Source: org_study_id

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