Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07629284

Home-Based Tele-Rehabilitation for Respiratory Function in Children With Duchenne Muscular Dystrophy

This study evaluates the feasibility and preliminary clinical effects of a home-based tele-rehabilitation program aimed at improving respiratory function in children with Duchenne Muscular Dystrophy (DMD).

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Age range

3 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 06351, South Korea

About this study

This is a prospective single-arm interventional study evaluating a 6-week home-based tele-rehabilitation program for respiratory function in children with Duchenne Muscular Dystrophy. The intervention includes weekly remote education sessions and home-based exercises, with assessments conducted before and after the intervention and a 2-week follow-up for adherence monitoring.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children aged 3 years or older with genetically confirmed Duchenne muscular dystrophy
  • Participants who are able to understand the study procedures and appropriately participate in the study

Exclusion criteria

  • Requirement for daytime ventilator support or invasive mechanical ventilation via tracheostomy (nighttime non-invasive ventilation such as positive airway pressure ventilation is allowed)
  • History of peripheral nerve injury
  • History of major surgery within 12 weeks prior to enrollment or expected major surgery during the study period
  • History of central nervous system disorders (e.g., cerebral infarction or spinal cord injury)
  • Severe cognitive impairment or other conditions that may interfere with participation in the study procedures

Treatment and study plan

Home-Based Respiratory Telerehabilitation Program

Behavioral

A 6-week caregiver-assisted home-based respiratory telerehabilitation program for children with Duchenne muscular dystrophy. The program includes weekly remote education sessions, respiratory muscle exercises, airway clearance training, relaxation positioning, and self-directed home exercises performed at least 5 times per week. Outcomes are assessed before and after the intervention and at 2-week follow-up.

Primary outcomes

  1. Feasibility of the Home-Based Respiratory Tele-rehabilitation Program

    Time frame: Baseline to immediately after the 6-week intervention

    Feasibility of the home-based respiratory telerehabilitation program will be assessed using exercise adherence rate, session attendance rate, and exercise log completion during the 6-week intervention period. These measures will be summarized descriptively as indicators of program feasibility. Higher percentages indicate better feasibility.

  2. Acceptability of the Home-Based Respiratory Tele-rehabilitation Program

    Time frame: Immediately after the 6-week intervention and at 2-week follow-up

    Acceptability of the home-based respiratory telerehabilitation program will be assessed using caregiver-reported satisfaction, perceived exercise difficulty, caregiver burden, and child participation questionnaires during the intervention period. Higher satisfaction and participation scores indicate greater acceptability, whereas higher perceived difficulty and caregiver burden scores indicate lower acceptability.

Secondary outcomes

  1. Inspiratory Muscle Strength

    Time frame: Baseline and immediately after the 6-week intervention

    Inspiratory muscle strength will be assessed using maximal inspiratory pressure (MIP). Measurements will be recorded in centimeters of water pressure (cmH2O). Higher values indicate greater inspiratory muscle strength.

  2. Expiratory Muscle Strength

    Time frame: Baseline and immediately after the 6-week intervention

    Expiratory muscle strength will be assessed using maximal expiratory pressure (MEP). Measurements will be recorded in centimeters of water pressure (cmH2O). Higher values indicate greater expiratory muscle strength.

  3. Respiratory Muscle Function

    Time frame: Baseline and immediately after the 6-week intervention

    Respiratory muscle function will be assessed using inspiratory muscle endurance time, surface electromyography (sEMG) of the sternocleidomastoid muscle, and respiratory muscle ultrasonography. Inspiratory muscle endurance will be measured in seconds, and respiratory muscle thickness will be measured in millimeters (mm). Higher endurance time and greater muscle thickness indicate improved respiratory muscle function.

  4. Physical Functional Performance

    Time frame: Baseline and immediately after the 6-week intervention

    Physical functional performance will be assessed using the Vignos Scale, Brooke Upper Extremity Functional Rating Scale, and North Star Ambulatory Assessment (NSAA). The Vignos Scale ranges from 1 to 10, with higher scores indicating greater lower extremity disability. The Brooke Scale ranges from 1 to 6, with higher scores indicating greater upper extremity functional limitation. The NSAA ranges from 0 to 34, with higher scores indicating better motor function.

  5. Functional Exercise Capacity

    Time frame: Baseline and immediately after the 6-week intervention

    Functional exercise capacity will be assessed using the 6-Minute Walk Test (6MWT). Total walking distance will be recorded in meters. Greater walking distance indicates better functional exercise capacity.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

Feasibility and Preliminary Clinical Effects of a Home-Based, Remotely Delivered Respiratory Rehabilitation Program for Children With Duchenne Muscular Dystrophy

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 5, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.