Samsung Medical Center
Seoul, 06351, South Korea
NCT Number: NCT07629284
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).
Interested in participating?
Request Info3 year and older
All sexes
Interventional
Not applicable
Seoul, 06351, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
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.
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.
Samsung Medical Center
Other
Feasibility and Preliminary Clinical Effects of a Home-Based, Remotely Delivered Respiratory Rehabilitation Program for Children With Duchenne Muscular Dystrophy
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