Adaptive Dance Activities for People With Stroke (MDI)
9. mai 2026 oppdatert av: Suzanne HS Lo, Chinese University of Hong Kong
Improving Participation in Stroke Survivors With Hemiparesis by Movement Improvisation Skill Building and Care Transition-friendly Adaptive Dance Activities: A Randomised Controlled Trial
The project will investigate the effects of a novel 12-week Movement Improvisation Skill-building and Adaptive Dance Intervention (MDI) on participation, balance, mobility, balance confidence, psychological well-being, and health-related quality of life in survivors with hemiparesis.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
A 2-arm, assessor-blinded, randomised controlled trial will be conducted.
Individuals who are 18-80 years old and have hemiparesis after a first-ever/recurrent ischaemic/haemorrhagic stroke will be recruited.
The participants will be randomly allocated to the control group receiving usual care or the intervention group receiving MDI and usual care.
Based on Bandura's principles of Self-efficacy and Outcome Expectation, MDI is an online/hybrid intervention aimed to assist survivors in developing body awareness, body sense, movement improvisational skills, and abilities in creating mental images of movements and balance during their transition of care from the acute settings to home.
The outcomes will be assessed before the intervention, immediately post-intervention, and 3 and 6 months post-intervention.
Studietype
Intervensjonell
Registrering (Antatt)
160
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Suzanne HS Lo, PhD
- Telefonnummer: 852-39434485
- E-post: suzannelo@cuhk.edu.hk
Studiesteder
-
-
-
Hong Kong, Hong Kong
- Rekruttering
- Non-government organisations
-
Ta kontakt med:
- Suzanne HS Lo, PhD
- Telefonnummer: 852-39434485
- E-post: suzannelo@cuhk.edu.hk
-
-
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
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- a first-ever/recurrent ischaemic/haemorrhagic stroke confirmed by imaging tests,
- receiving in-patient care at an acute stroke unit,
- a National Institutes of Health Stroke Scale (NIHSS) total score of <16 (mild to moderate stroke),
- hemiparesis after stroke with the affected limb(s) scoring 1-3 on the NIHSS motor arm and/or motor leg items, respectively (drift to no effort against gravity),
- a modified Rankin Scale (mRS) score of 2-4 (slight to moderately severe disability), and
- a Montreal Cognitive Assessment (MoCA) score of >2nd percentile.
Exclusion Criteria:
- transient ischaemic attack,
- subdural or epidural haemorrhage,
- cerebrovascular event due to brain tumour or a head injury,
- neurologic, orthopaedic, muscular, rheumatic or vestibular condition that can interfere with participation in the intervention such as seizure or spinal injury,
- mental condition such as depression or schizophrenia, or
- visual or auditory impairment that cannot be corrected by visual/hearing aids.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Vanlig omsorg
|
|
|
Eksperimentell: Movement Improvisation Skill-building and Adaptive Dance Intervention
The MDI is a hybrid in-person/online intervention aimed at developing body awareness, body sense, movement improvisational skills, and the ability to create mental images of movements and balance among stroke survivors with hemiparesis.
|
The MDI is a hybrid in-person/online intervention aimed at developing body awareness, body sense, movement improvisational skills, and abilities in creating mental images of movements and balance among stroke survivors with hemiparesis.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in the level of participation in daily and social activities
Tidsramme: From baseline to immediately, 3 months and 6 months post-intervention
|
The Reintegration to Normal Living Index (Chinese version) will be used to assess participants' participation in daily and social activities.
|
From baseline to immediately, 3 months and 6 months post-intervention
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in the level of balancing ability
Tidsramme: From baseline to immediately, 3 months and 6 months post-intervention
|
The 14-item Mini- Balance Evaluation Systems Test will be used to measure participants' anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait.
|
From baseline to immediately, 3 months and 6 months post-intervention
|
|
Change in the level of mobility
Tidsramme: From baseline to immediately, 3 months and 6 months post-intervention
|
The 6-minute walk test (MWT) will be performed according to the American Thoracic Society guidelines.
|
From baseline to immediately, 3 months and 6 months post-intervention
|
|
Change in the level of balance confidence
Tidsramme: From baseline to immediately, 3 months and 6 months post-intervention
|
The Activities-specific Balance Confidence Scale (Chinese version) will be used to assess participants' confidence in balance when performing 16 daily functional activities.
|
From baseline to immediately, 3 months and 6 months post-intervention
|
|
Change in the level of psychological well-being
Tidsramme: From baseline to immediately, 3 months and 6 months post-intervention
|
Participants' emotional well-being will be measured by the Hospital Anxiety and Depression Scale (Chinese version).
|
From baseline to immediately, 3 months and 6 months post-intervention
|
|
Change in the level of health-related quality of life
Tidsramme: From baseline to immediately, 3 months and 6 months post-intervention
|
The EuroQoL 5 Dimension (Chinese version) will be used.
It contains 5 dimensions (mobility, self-care, usual activities, pain/ discomfort, anxiety/depression),
|
From baseline to immediately, 3 months and 6 months post-intervention
|
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)
1. januar 2025
Primær fullføring (Antatt)
31. desember 2028
Studiet fullført (Antatt)
31. desember 2029
Datoer for studieregistrering
Først innsendt
9. mai 2026
Først innsendt som oppfylte QC-kriteriene
9. mai 2026
Først lagt ut (Faktiske)
15. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
15. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 14618024
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
The information will be provided on request.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .