NCT07629284

Brief Summary

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).

Trial Health

75
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
9mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress33%
Jan 2026Mar 2027

Study Start

First participant enrolled

January 23, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

June 5, 2026

Status Verified

June 1, 2026

Enrollment Period

1.1 years

First QC Date

May 20, 2026

Last Update Submit

June 1, 2026

Conditions

Duchene Muscular Dystrophy

Keywords

Duchene Muscular DystrophyTele-rehabilitationRespiratory FunctionHome-based ExerciseCaregiver Education

Outcome Measures

Primary Outcomes (2)

  • Feasibility of the Home-Based Respiratory Tele-rehabilitation Program

    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.

    Baseline to immediately after the 6-week intervention

  • Acceptability of the Home-Based Respiratory Tele-rehabilitation Program

    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.

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

Secondary Outcomes (5)

  • Inspiratory Muscle Strength

    Baseline and immediately after the 6-week intervention

  • Expiratory Muscle Strength

    Baseline and immediately after the 6-week intervention

  • Respiratory Muscle Function

    Baseline and immediately after the 6-week intervention

  • Physical Functional Performance

    Baseline and immediately after the 6-week intervention

  • Functional Exercise Capacity

    Baseline and immediately after the 6-week intervention

Study Arms (1)

Home-Based Telerehabilitation Group

EXPERIMENTAL

Participants with Duchenne muscular dystrophy will receive a 6-week home-based telerehabilitation respiratory program including weekly remote education sessions, caregiver-assisted respiratory exercises, self-directed home exercises, and exercise log monitoring. Outcomes will be assessed at pre-intervention, post-intervention, and 2-week follow-up.

Behavioral: Home-Based Respiratory Telerehabilitation Program

Interventions

Home-Based Respiratory Telerehabilitation ProgramBEHAVIORAL

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.

Home-Based Telerehabilitation Group

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 20, 2026

First Posted

June 5, 2026

Study Start

January 23, 2026

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

June 5, 2026

Record last verified: 2026-06

Locations

KR(1)