NCT06109103

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 31, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

December 15, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

10 months

First QC Date

June 19, 2023

Last Update Submit

October 27, 2023

Conditions

Outcome Measures

Primary Outcomes (8)

  • Kinesthetic and Visual Imagery Questionnaire (KVIQ)-10

    Kinesthetic and Visual Imagery Questionnaire-10 is a 10-item version consisting of 5 movements, and each item is scored between 1 and 5 in the same way. The total score of the questionnaire varies between 10-50. The kinesthetic and visual imagery sub-scores range from 5 to 25. High scores indicate good visualization ability.

    Change from Baseline at 8 weeks

  • Movement Imagery Questionnaire for Children (MIQ-C)

    During this test, which is applied with a physiotherapist, children will be asked to physically perform the movement in the items in the instruction once, and then imagine that they are doing the movement from 3 different perspectives. The clarity of these imagery will be scored using a Likert-type scale from 1 (very difficult to feel) to 7 (very easy to feel).

    Change from Baseline at 8 weeks

  • Mental Chronometry Test

    In the mental stopwatch application; Children will be asked to make a movement and then be asked to imagine that movement. In our study, mental chronometer measurements for timed performance tests (standing from supine to standing up, walking 10 meters, climbing 4 steps, descending 4 steps) and the Four Square Step Test (DKAT) will be made with a stopwatch. Simultaneously with the start command, the stopwatch will be started, and the individual will start the imagery of the task and the stopwatch will be stopped as soon as he/she indicates that he/she has finished the imagery. The temporal coherence between real and imagined motion will be calculated in terms of delta time with the formula "(real motion-imagined motion)/\[(actual motion + imagined motion)/2\] x 100".

    Change from Baseline at 8 weeks

  • 6 minutes walk test

    participants were instructed to travel as far and as fast as possible in six minutes on 25 meter-indoor course.

    Change from Baseline at 8 weeks

  • Timed performance tests

    Timed function tests included time taken to stand from a supine position, time taken to run 10 m, time taken to climb 4 standard-sized stairs, time taken to descend 4 standard-sized stairs

    Change from Baseline at 8 weeks

  • Four Square Step Test

    Four Square Step Test is performed by asking the child to step clockwise and counterclockwise from square 1 to square 4 against time on a floor that is divided by sticks to form 4 squares and numbered from 1 to 4. It is a timed test measured with a stopwatch. Time starts when the child lifts his or her foot to take a step. Time is stopped when both feet reach square 1 again. The dynamic balance of the child is interpreted by looking at the completion time of the test. Accordingly, shorter test time indicates better dynamic balance.

    Change from Baseline at 8 weeks

  • Motor Function Measurement (MFM)

    The items in this outcome measure, which evaluate functions in 3 different sections (standing and transfers (D1), proximal/axial (D2) and distal (D3)) in a total of 32 items, are scored between 0 and 3. 0; cannot initiate any movement and maintain the starting position, 1; partially completes the move, 2; makes movement slowly and visibly clumsily, with compensations, 3; makes the movement in the specified standard pattern. A score between 0-96 is taken from the scale. High scores indicate higher motor function.

    Change from Baseline at 8 weeks

  • North Star Ambulation Assessment

    Using the NSAA, patients' ambulations are scored with a 3-level grading system as "acting normally without assistance=2", "doing it with compensation=1" and "inability to perform the activity independently=0". It contains 17 items. . The total score ranges between 0-34. A higher score indicates better ambulation and motor function.

    Change from Baseline at 8 weeks

Secondary Outcomes (2)

  • PedsQL Multidimensional Fatigue Scale

    Change from Baseline at 8 weeks

  • Pediatric Quality of Life Inventory-3.0 (PedsQL-3.0)-Neuromuscular Module

    Change from Baseline at 8 weeks

Study Arms (3)

Group 1

EXPERIMENTAL

Telerehabilitation-based physiotherapy program + telerehabilitation-based motor imagery training Telerehabilitation-based physiotherapy program; Eight (8) weeks, three (3) sessions per week, 40 minutes, using an image-based rehabilitation system, by connecting volunteers with a physiotherapist online in their home environment. Telerehabilitation-based motor imagery training will only be applied to the treatment group by the same physiotherapist for 15-20 minutes in addition to the physiotherapy training, three (3) sessions per week for eight (8) weeks.

Procedure: telerehabilitation-based motor imagery trainingProcedure: telerehabilitation-based physiotheraphy training

Group 2

ACTIVE COMPARATOR

Telerehabilitation-based physiotherapy program Telerehabilitation-based physiotherapy program; Eight (8) weeks, three (3) sessions per week, 40 minutes, using an image-based rehabilitation system, by connecting volunteers with a physiotherapist online in their home environment.

Procedure: telerehabilitation-based physiotheraphy training

Healthy children group

NO INTERVENTION

No intervention will be applied.

Interventions

Motor imagery is defined as the mental thinking of a movement without actual movement being revealed. Many of the currently available physiotherapy and rehabilitation approaches are designed to stimulate damaged motor neural connections through neuroplasticity. based on real movements. Studies have shown that similar brain regions are activated during motor imagery and real movement. By repeatedly visualizing the same movement, people can improve their motor activity skills such as lifting weights, playing the piano or performing surgery. These findings suggest that motor imagery provides motor learning by strengthening synaptic connections depending on activity.

Group 1

The telerehabilitation application will be carried out by video conference method, one of the image-based telerehabilitation technologies. The telerehabilitation-based physiotherapy program will be administered to both Group 1 and Group 2 children by a physiotherapist experienced in the physiotherapy of neuromuscular diseases, excluding the researchers who performed the randomization and evaluations.

Group 1Group 2

Eligibility Criteria

Age7 Years - 15 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsDuchenne muscular dystrophy (DMD) is an X-linked recessive genetic disorder with a prevalence of approximately 1/3600-6000 live male births.
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06680, Turkey (Türkiye)

Location

Related Publications (1)

  • Bora-Zereyak M, Bulut N, Yilmaz O, Haliloglu G, Alemdaroglu-Gurbuz I. The effects of telerehabilitation-based motor imagery training on motor imagery ability, motor function and physical performance in Duchenne muscular dystrophy. Disabil Rehabil. 2025 Jul;47(15):3866-3875. doi: 10.1080/09638288.2024.2438251. Epub 2024 Dec 9.

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Condition Hierarchy (Ancestors)

Muscular DystrophiesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • İpek Gürbüz, Prof, PhD

    Hacettepe University

    STUDY DIRECTOR

Central Study Contacts

merve bora zereyak

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

June 19, 2023

First Posted

October 31, 2023

Study Start

December 15, 2023

Primary Completion

October 1, 2024

Study Completion

December 1, 2025

Last Updated

October 31, 2023

Record last verified: 2023-10

Locations