Clinical trial NCT06109103: Telerehabilitation-based Motor Imagery Training in Children With Duchenne Muscular Dystrophy
Official title: Investigation of the Effects of Telerehabilitation-based Motor Imagery Training on Motor Imagery Skills, Motor Function and Physical Performance in Children With Duchenne Muscular Dystrophy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Duchenne Muscular Dystrophy
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 36
Sex: MALE
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: When the field of neurorehabilitation is examined, most of the current physiotherapy and rehabilitation approaches are based on real movements to stimulate damaged motor neural connections through neuroplasticity. However, since studies have shown that similar brain regions are activated during real movement with motor imagery, which is defined as imagining movement without actually revealing the movement, the findings of these studies suggest that motor functions can be improved through neuroplasticity, just like real movement. When the literature especially in the pediatric population is examined; The effectiveness of motor imagery training with children with cerebral palsy was examined and positive results were found. However, there are no such studies on children with DMD. In addition, telerehabilitation-based motor imagery training is a very rare treatment modality that requires further research. Therefore, the aim of the study is to investigate the effect of telerehabilitation-based motor imagery training on motor imagery ability, motor function and physical performance in children with DMD. The secondary aim of the study is to investigate the effects of telerehabilitation-based motor imagery training on psychosocial factors including fatigue and quality of life in children with DMD.

Detailed description: The primary aims of this study are;

1. To determine the motor imagery ability in children with DMD and compare it with healthy children,
2. To investigate the effect of telerehabilitation-based motor imagery training on motor imagery ability, motor function and physical performance in children with DMD. The secondary aim of the study is to investigate the effects of telerehabilitation-based motor imagery training on psychosocial factors including fatigue and quality of life in children with DMD.

It is aimed that the data obtained as a result of this study will guide physiotherapists while preparing rehabilitation programs for DMD patients. When the literature is examined, it is reported that motor imagery training is used in many pediatric diseases such as cerebral palsy, brachial plexus, developmental coordination disorder and has positive effects. No study was found in which the effectiveness of motor imagery training was investigated in children with DMD. With this study, it is aimed to contribute to the literature by investigating the effects of motor imagery training to be applied to children with DMD on motor imagery skills, motor function and physical performance.

After determining the functional levels of the children with DMD included in our study according to the Brooke Lower Extremity Functional Classification, a stratified randomization method will be applied by a researcher who was not involved in the evaluation and treatment intervention based on these levels. Thus, patients with DMD will be divided into 2 groups as Group 1 and Group 2. The above-mentioned evaluations of children with DMD will be made twice, before and after the treatment, by a researcher other than the researcher who performed the patient selection and randomization. In order to compare the pre-educational motor imagery skills of children with DMD with healthy children, the group of healthy children will be evaluated only once and no training will be applied to this group.

The interventions to be applied to the groups in the study are summarized below;

Group 1 (children with DMD): Telerehabilitation-based physiotherapy program + telerehabilitation-based motor imagery training

Group 2 (children with DMD): Telerehabilitation-based physiotherapy program

Healthy child group: No intervention will be applied Sessions will be planned three (3) times a week for eight (8) weeks, and session times will be planned by considering the fatigue levels of the children and school hours.

Eligibility criteria: Inclusion Criteria:

* Confirmation of DMD diagnosis by clinical, diagnostic studies and molecular genetic studies,
* According to Brooke Lower Extremity Functional Classification, it is at Circuit 1-2 levels (early period),
* To be between the ages of 7-15,
* To be able to comply with the physiotherapist's instructions, to have a score of 27 and above (between 27 and 35 indicates normal cognitive level) in the Modified Mini Mental Test,
* Having a computer and an active internet connection at home

Exclusion Criteria:

* Inability to communicate adequately with the physiotherapist,
* In the last 6 months, having deformities that may prevent performance evaluations or physiotherapy program, having any injury and / or surgery of the lower / upper extremities
* Having any additional neurological/orthopedic problems other than DMD

Primary outcomes:
measure: Kinesthetic and Visual Imagery Questionnaire (KVIQ)-10
timeFrame: Change from Baseline at 8 weeks
measure: Movement Imagery Questionnaire for Children (MIQ-C)
timeFrame: Change from Baseline at 8 weeks
measure: Mental Chronometry Test
timeFrame: Change from Baseline at 8 weeks
measure: 6 minutes walk test
timeFrame: Change from Baseline at 8 weeks
measure: Timed performance tests
timeFrame: Change from Baseline at 8 weeks
measure: Four Square Step Test
timeFrame: Change from Baseline at 8 weeks
measure: Motor Function Measurement (MFM)
timeFrame: Change from Baseline at 8 weeks
measure: North Star Ambulation Assessment
timeFrame: Change from Baseline at 8 weeks
Secondary outcomes:
measure: PedsQL Multidimensional Fatigue Scale
timeFrame: Change from Baseline at 8 weeks
measure: Pediatric Quality of Life Inventory-3.0 (PedsQL-3.0)-Neuromuscular Module
timeFrame: Change from Baseline at 8 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: İpek Gürbüz, Prof, PhD
role: STUDY_DIRECTOR
References: