Motor Imagery on Children With DMD on Gait and Balance Functions

NCT05601986 | Recruiting

• 1 other identifier: MI on DMD
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Duchenne Muscular Dystrophy

Keywords

Gait; Balance; Duchenne Muscular Dystrophy

Outcome Measures

Primary Outcomes (5)

• gait analysis1

  Change from Baseline Stride length in meters

  one week before the intervention and one week after the intervention

• gait analysis2

  Change from Baseline stride width in meters

  one week before the intervention and one week after the intervention

• gait analysis3

  Change from Baseline Systolic cadence

  one week before the intervention and one week after the intervention

• gait analysis4

  Change from Baseline walking speed in meters/second

  one week before the intervention and one week after the intervention

• balance

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

  one week before the intervention and one week after the intervention

Secondary Outcomes (1)

• muscle strength measurement

  one week before the intervention and one week after the intervention

Study Arms (2)

Physiotherapy and Rehabilitation Program

OTHER

Control Group

Other: Physiotherapy and Rehabilitation Program

Additional Motor Imagery Training to Physiotherapy and Rehabilitation Program

EXPERIMENTAL

Intervention Group

Other: Physiotherapy and Rehabilitation Program; Other: Additional Motor Imagery Training to Physiotherapy and Rehabilitation Program

Interventions

Physiotherapy and Rehabilitation Program 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.

Also known as: Control group

Additional Motor Imagery Training to Physiotherapy and Rehabilitation Program; Physiotherapy and Rehabilitation Program

Additional Motor Imagery Training to Physiotherapy and Rehabilitation Program 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.

Also known as: Intervention group

Additional Motor Imagery Training to Physiotherapy and Rehabilitation Program

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gülsena Utku: lead

Study Sites (1)

Biruni University

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Interventions

Physical Therapy Modalities; Rehabilitation; Control Groups

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Therapeutics; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Arzu Razak Özdinçler, Prof

  Biruni University

  STUDY DIRECTOR

Central Study Contacts

Gülsena Utku Umut

CONTACT

+905370664646; gulsenautku@halic.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: November 1, 2022
• Study Start: December 16, 2022
• Primary Completion: July 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)