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Motor Imagery on Children With DMD on Gait and Balance Functions

Primary Purpose

Duchenne Muscular Dystrophy

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Physiotherapy and Rehabilitation Program
Additional Motor Imagery Training to Physiotherapy and Rehabilitation Program
Sponsored by
Gülsena Utku
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Duchenne Muscular Dystrophy focused on measuring Gait, Balance, Duchenne Muscular Dystrophy

Eligibility Criteria

5 Years - 12 Years (Child)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Biruni UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Physiotherapy and Rehabilitation Program

Additional Motor Imagery Training to Physiotherapy and Rehabilitation Program

Arm Description

Control Group

Intervention Group

Outcomes

Primary Outcome Measures

gait analysis1
Change from Baseline Stride length in meters
gait analysis2
Change from Baseline stride width in meters
gait analysis3
Change from Baseline Systolic cadence
gait analysis4
Change from Baseline walking speed in meters/second
balance
Change from Baseline Pediatric Balance Scale in grades 0-56 points

Secondary Outcome Measures

muscle strength measurement
Strength measurements of lower extremity muscles

Full Information

First Posted
October 20, 2022
Last Updated
September 27, 2023
Sponsor
Gülsena Utku
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1. Study Identification

Unique Protocol Identification Number
NCT05601986
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 16, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gülsena Utku

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Duchenne Muscular Dystrophy
Keywords
Gait, Balance, Duchenne Muscular Dystrophy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physiotherapy and Rehabilitation Program
Arm Type
Other
Arm Description
Control Group
Arm Title
Additional Motor Imagery Training to Physiotherapy and Rehabilitation Program
Arm Type
Experimental
Arm Description
Intervention Group
Intervention Type
Other
Intervention Name(s)
Physiotherapy and Rehabilitation Program
Other Intervention Name(s)
Control group
Intervention Description
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
Intervention Name(s)
Additional Motor Imagery Training to Physiotherapy and Rehabilitation Program
Other Intervention Name(s)
Intervention group
Intervention Description
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.
Primary Outcome Measure Information:
Title
gait analysis1
Description
Change from Baseline Stride length in meters
Time Frame
one week before the intervention and one week after the intervention
Title
gait analysis2
Description
Change from Baseline stride width in meters
Time Frame
one week before the intervention and one week after the intervention
Title
gait analysis3
Description
Change from Baseline Systolic cadence
Time Frame
one week before the intervention and one week after the intervention
Title
gait analysis4
Description
Change from Baseline walking speed in meters/second
Time Frame
one week before the intervention and one week after the intervention
Title
balance
Description
Change from Baseline Pediatric Balance Scale in grades 0-56 points
Time Frame
one week before the intervention and one week after the intervention
Secondary Outcome Measure Information:
Title
muscle strength measurement
Description
Strength measurements of lower extremity muscles
Time Frame
one week before the intervention and one week after the intervention

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gülsena Utku Umut
Phone
+905370664646
Email
gulsenautku@halic.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arzu Razak Özdinçler, Prof
Organizational Affiliation
Biruni University
Official's Role
Study Director
Facility Information:
Facility Name
Biruni University
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gülsena Utku Umut
Phone
+905370664646
Email
gulsenautkuumut@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Motor Imagery on Children With DMD on Gait and Balance Functions

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