Duchene Muscular DystrophyNCT07629284
Home-Based Tele-Rehabilitation for Respiratory Function in Children With Duchenne Muscular Dystrophy
A study testing Home-Based Respiratory Telerehabilitation Program in people with Duchene Muscular Dystrophy, run by Samsung Medical Center at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Duchene Muscular Dystrophy
- What is being tested?
- Home-Based Respiratory Telerehabilitation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Jan 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Feasibility and Preliminary Clinical Effects of a Home-Based, Remotely Delivered Respiratory Rehabilitation Program for 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).
Read the detailed description
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.
- Conditions
- Duchene Muscular Dystrophy
- Being tested
- Home-Based Respiratory Telerehabilitation Program
- Keywords
- Duchene Muscular Dystrophy, Tele-rehabilitation, Respiratory Function, Home-based Exercise, Caregiver Education
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-Based Respiratory Telerehabilitation ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Home-Based Respiratory Telerehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Immediately after the 6-week intervention and at 2-week follow-up
Secondary outcomes (5)
Inspiratory Muscle Strength
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.
Measured: Baseline and immediately after the 6-week intervention
Expiratory Muscle Strength
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.
Measured: Baseline and immediately after the 6-week intervention
Respiratory Muscle Function
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.
Measured: Baseline and immediately after the 6-week intervention
Physical Functional Performance
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.
Measured: Baseline and immediately after the 6-week intervention
Functional Exercise Capacity
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.
Measured: Baseline and immediately after the 6-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start23 Jan 2026
- Primary completion28 Feb 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duchene Muscular DystrophyStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong Yi Kwon, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07629284
- Sponsor's protocol ID
- 2025-12-123
- Status last verified
- Jun 2026
- First submitted
- 20 May 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Clinical Effects of a Home-Based, Remotely Delivered Respiratory Rehabilitation Program for Children With Duchenne Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT07629284
- Acronym / sponsor ID
- 2025-12-123
- Conditions
- Duchene Muscular Dystrophy
- Keywords
- Duchene Muscular Dystrophy, Tele-rehabilitation, Respiratory Function, Home-based Exercise, Caregiver Education
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 23 Jan 2026 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home-Based Telerehabilitation Group | Experimental | Behavioral: Home-Based Respiratory Telerehabilitation ProgramParticipants 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. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-Based Respiratory Telerehabilitation ProgramA 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. | Behavioural | Home-Based Telerehabilitation Group |
Primary outcome
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.
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.
5 secondary outcomes
Inspiratory Muscle Strength
Time frame: Baseline and immediately after the 6-week intervention
Expiratory Muscle Strength
Time frame: Baseline and immediately after the 6-week intervention
Respiratory Muscle Function
Time frame: Baseline and immediately after the 6-week intervention
Physical Functional Performance
Time frame: Baseline and immediately after the 6-week intervention
Functional Exercise Capacity
Time frame: Baseline and immediately after the 6-week intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-Based Respiratory Telerehabilitation Program in people with Duchene Muscular Dystrophy, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the Home-Based Respiratory Tele-rehabilitation Program (time frame: Baseline to immediately after the 6-week intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.