- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05601986
Motor Imagery on Children With DMD on Gait and Balance Functions
Investigation of the Effect of Motor Imagery on Gait and Balance Functions in Children With Duchenne Muscular Dystrophy
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gülsena Utku Umut
- Phone Number: +905370664646
- Email: gulsenautku@halic.edu.tr
Study Locations
-
-
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Istanbul, Turkey
- Recruiting
- Biruni University
-
Contact:
- GÜLSENA UTKU UMUT
- Phone Number: +905370664646
- Email: gulsenautkuumut@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
|
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:
|
Experimental: Additional Motor Imagery Training to Physiotherapy and Rehabilitation Program
Intervention Group
|
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:
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:
|
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
Sponsor
Investigators
- Study Director: Arzu Razak Özdinçler, Prof, Biruni University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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