- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07591272
Adaptive Dance Activities for People With Stroke (MDI)
9. maj 2026 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
160
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Suzanne HS Lo, PhD
- Telefonnummer: 852-39434485
- E-mail: suzannelo@cuhk.edu.hk
Studiesteder
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Hong Kong, Hong Kong
- Rekruttering
- Non-government organisations
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Kontakt:
- Suzanne HS Lo, PhD
- Telefonnummer: 852-39434485
- E-mail: suzannelo@cuhk.edu.hk
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-
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
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Ingen indgriben: Sædvanlig pleje
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Eksperimentel: 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.
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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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in the level of participation in daily and social activities
Tidsramme: From baseline to immediately, 3 months and 6 months post-intervention
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The Reintegration to Normal Living Index (Chinese version) will be used to assess participants' participation in daily and social activities.
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From baseline to immediately, 3 months and 6 months post-intervention
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in the level of balancing ability
Tidsramme: From baseline to immediately, 3 months and 6 months post-intervention
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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.
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From baseline to immediately, 3 months and 6 months post-intervention
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Change in the level of mobility
Tidsramme: From baseline to immediately, 3 months and 6 months post-intervention
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The 6-minute walk test (MWT) will be performed according to the American Thoracic Society guidelines.
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From baseline to immediately, 3 months and 6 months post-intervention
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Change in the level of balance confidence
Tidsramme: From baseline to immediately, 3 months and 6 months post-intervention
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The Activities-specific Balance Confidence Scale (Chinese version) will be used to assess participants' confidence in balance when performing 16 daily functional activities.
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From baseline to immediately, 3 months and 6 months post-intervention
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Change in the level of psychological well-being
Tidsramme: From baseline to immediately, 3 months and 6 months post-intervention
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Participants' emotional well-being will be measured by the Hospital Anxiety and Depression Scale (Chinese version).
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From baseline to immediately, 3 months and 6 months post-intervention
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Change in the level of health-related quality of life
Tidsramme: From baseline to immediately, 3 months and 6 months post-intervention
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The EuroQoL 5 Dimension (Chinese version) will be used.
It contains 5 dimensions (mobility, self-care, usual activities, pain/ discomfort, anxiety/depression),
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From baseline to immediately, 3 months and 6 months post-intervention
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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)
1. januar 2025
Primær færdiggørelse (Anslået)
31. december 2028
Studieafslutning (Anslået)
31. december 2029
Datoer for studieregistrering
Først indsendt
9. maj 2026
Først indsendt, der opfyldte QC-kriterier
9. maj 2026
Først opslået (Faktiske)
15. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 14618024
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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IPD-planbeskrivelse
The information will be provided on request.
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