Home-Based Tele-Rehabilitation for Respiratory Function in Children With Duchenne Muscular Dystrophy
1 juni 2026 bijgewerkt door: Jeong Yi Kwon, Samsung Medical Center
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).
Studie Overzicht
Toestand
Aanmelden op uitnodiging
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
12
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Seoul
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Seoul, Seoul, Zuid -Korea, 06351
- Samsung Medical Center
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Home-Based Telerehabilitation Group
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.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Feasibility of the Home-Based Respiratory Tele-rehabilitation Program
Tijdsspanne: Baseline to immediately after the 6-week intervention
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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.
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Baseline to immediately after the 6-week intervention
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Acceptability of the Home-Based Respiratory Tele-rehabilitation Program
Tijdsspanne: Immediately after the 6-week intervention and at 2-week follow-up
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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.
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Immediately after the 6-week intervention and at 2-week follow-up
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Inspiratory Muscle Strength
Tijdsspanne: Baseline and immediately after the 6-week intervention
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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.
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Baseline and immediately after the 6-week intervention
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Expiratory Muscle Strength
Tijdsspanne: Baseline and immediately after the 6-week intervention
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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.
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Baseline and immediately after the 6-week intervention
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Respiratory Muscle Function
Tijdsspanne: Baseline and immediately after the 6-week intervention
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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.
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Baseline and immediately after the 6-week intervention
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Physical Functional Performance
Tijdsspanne: Baseline and immediately after the 6-week intervention
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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.
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Baseline and immediately after the 6-week intervention
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Functional Exercise Capacity
Tijdsspanne: Baseline and immediately after the 6-week intervention
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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.
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Baseline and immediately after the 6-week intervention
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
23 januari 2026
Primaire voltooiing (Geschat)
28 februari 2027
Studie voltooiing (Geschat)
31 maart 2027
Studieregistratiedata
Eerst ingediend
20 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
1 juni 2026
Eerst geplaatst (Werkelijk)
5 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
5 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
1 juni 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2025-12-123
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
ONBESLIST
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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