Home-Based Tele-Rehabilitation for Respiratory Function in Children With Duchenne Muscular Dystrophy
1. juni 2026 oppdatert av: 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).
Studieoversikt
Status
Påmelding etter invitasjon
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Intervensjonell
Registrering (Antatt)
12
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Seoul
-
Seoul, Seoul, Sør -Korea, 06351
- Samsung Medical Center
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Feasibility of the Home-Based Respiratory Tele-rehabilitation Program
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Inspiratory Muscle Strength
Tidsramme: 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
Tidsramme: 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.
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Baseline and immediately after the 6-week intervention
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Respiratory Muscle Function
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
23. januar 2026
Primær fullføring (Antatt)
28. februar 2027
Studiet fullført (Antatt)
31. mars 2027
Datoer for studieregistrering
Først innsendt
20. mai 2026
Først innsendt som oppfylte QC-kriteriene
1. juni 2026
Først lagt ut (Faktiske)
5. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2025-12-123
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