Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Home-Based Tele-Rehabilitation for Respiratory Function in Children With Duchenne Muscular Dystrophy

1. juni 2026 opdateret af: 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).

Studieoversigt

Status

Tilmelding efter invitation

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

12

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Sydkorea
    • Seoul
      • Seoul, Seoul, Sydkorea, 06351
        • Samsung Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: Home-Based Respiratory Telerehabilitation Program
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Feasibility of the Home-Based Respiratory Tele-rehabilitation Program
Tidsramme: 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.
Baseline to immediately after the 6-week intervention
Acceptability of the Home-Based Respiratory Tele-rehabilitation Program
Tidsramme: 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.
Immediately after the 6-week intervention and at 2-week follow-up

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Inspiratory Muscle Strength
Tidsramme: 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.
Baseline and immediately after the 6-week intervention
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.
Baseline and immediately after the 6-week intervention
Respiratory Muscle Function
Tidsramme: 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.
Baseline and immediately after the 6-week intervention
Physical Functional Performance
Tidsramme: 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.
Baseline and immediately after the 6-week intervention
Functional Exercise Capacity
Tidsramme: 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.
Baseline and immediately after the 6-week intervention

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Samsung Medical Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

23. januar 2026

Primær færdiggørelse (Anslået)

28. februar 2027

Studieafslutning (Anslået)

31. marts 2027

Datoer for studieregistrering

Først indsendt

20. maj 2026

Først indsendt, der opfyldte QC-kriterier

1. juni 2026

Først opslået (Faktiske)

5. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2025-12-123

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Duchene muskeldystrofi

Kliniske forsøg med Home-Based Respiratory Telerehabilitation Program

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Kazakhstan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner