Duchenne Muscular DystrophyNCT05601986
Motor Imagery on Children With DMD on Gait and Balance Functions
A study testing Physiotherapy and Rehabilitation Program and Additional Motor Imagery Training to Physiotherapy and Rehabilitation Program in people with Duchenne Muscular Dystrophy, run by Gülsena Utku at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 12 years, men only
- Conditions the study is for
- Duchenne Muscular Dystrophy
- What is being tested?
- Physiotherapy and Rehabilitation Program and Additional Motor Imagery Training to Physiotherapy and Rehabilitation Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Dec 2022to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Biruni University
Istanbul
Gülsena Utku Umut, +905370664646, gulsenautkuumut@gmail.com
About this study
Official title: 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.
- Conditions
- Duchenne Muscular Dystrophy
- Being tested
- Physiotherapy and Rehabilitation Program, Additional Motor Imagery Training to Physiotherapy and Rehabilitation Program
- Keywords
- Gait, Balance, Duchenne Muscular Dystrophy
- Medical subject headings
- Muscular Dystrophy, Duchenne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy and Rehabilitation ProgramOther
Also called 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.
Additional Motor Imagery Training to Physiotherapy and Rehabilitation ProgramOther
Also called Intervention group
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.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy and Rehabilitation Program | Other | Control Group Receives: Other: Physiotherapy and Rehabilitation Program |
| Additional Motor Imagery Training to Physiotherapy and Rehabilitation Program | Experimental | Intervention Group Receives: Other: Physiotherapy and Rehabilitation Program; Other: Additional Motor Imagery Training to Physiotherapy and Rehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
gait analysis1
Change from Baseline Stride length in meters
Measured: one week before the intervention and one week after the intervention
gait analysis2
Change from Baseline stride width in meters
Measured: one week before the intervention and one week after the intervention
gait analysis3
Change from Baseline Systolic cadence
Measured: one week before the intervention and one week after the intervention
gait analysis4
Change from Baseline walking speed in meters/second
Measured: one week before the intervention and one week after the intervention
balance
Change from Baseline Pediatric Balance Scale in grades 0-56 points
Measured: one week before the intervention and one week after the intervention
Secondary outcomes (1)
muscle strength measurement
Strength measurements of lower extremity muscles
Measured: one week before the intervention and one week after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start16 Dec 2022
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duchenne Muscular DystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gülsena Utku
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gülsena Utku, Halic University
- Investigators
- Arzu Razak Özdinçler, Prof, Study director, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601986
- Sponsor's protocol ID
- MI on DMD
- Status last verified
- Feb 2024
- First submitted
- 20 Oct 2022
- Last updated
- 29 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Motor Imagery on Gait and Balance Functions in Children With Duchenne Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT05601986
- Acronym / sponsor ID
- MI on DMD
- Conditions
- Duchenne Muscular Dystrophy
- Keywords
- Gait, Balance, Duchenne Muscular Dystrophy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Gülsena UtkuUniversity, hospital or other
- Study start
- 16 Dec 2022 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 1 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy and Rehabilitation Program | Other | Other: Physiotherapy and Rehabilitation ProgramControl Group |
| Additional Motor Imagery Training to Physiotherapy and Rehabilitation Program | Experimental | Other: Physiotherapy and Rehabilitation Program, Other: Additional Motor Imagery Training to Physiotherapy and Rehabilitation ProgramIntervention Group |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiotherapy and Rehabilitation ProgramAlso: Control groupThe 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 | Additional Motor Imagery Training to Physiotherapy and Rehabilitation Program, Physiotherapy and Rehabilitation Program |
| Additional Motor Imagery Training to Physiotherapy and Rehabilitation ProgramAlso: Intervention groupThe 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 | Additional Motor Imagery Training to Physiotherapy and Rehabilitation Program |
Primary outcome
gait analysis1
Time frame: one week before the intervention and one week after the intervention
Change from Baseline Stride length in meters
gait analysis2
Time frame: one week before the intervention and one week after the intervention
Change from Baseline stride width in meters
gait analysis3
Time frame: one week before the intervention and one week after the intervention
Change from Baseline Systolic cadence
gait analysis4
Time frame: one week before the intervention and one week after the intervention
Change from Baseline walking speed in meters/second
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
1 secondary outcome
muscle strength measurement
Time frame: one week before the intervention and one week after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arzu Razak Özdinçler, Prof study director
Biruni University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy and Rehabilitation Program and Additional Motor Imagery Training to Physiotherapy and Rehabilitation Program in people with Duchenne Muscular Dystrophy, run by Gülsena Utku at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gülsena Utku Umut (+905370664646, gulsenautku@halic.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gait analysis1 (time frame: one week before the intervention and one week after the intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.