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Effects of Home-based vs. Clinic-based Rehabilitation on Sensorimotor, Cognition, Daily Function, and Participation

17. mai 2017 oppdatert av: Chang Gung Memorial Hospital

Effects of Home-based vs. Clinic-based Rehabilitation on Sensorimotor, Cognition, Daily Function, and Participation: Bilateral Training With and Without Mirror Feedback Program

The purpose of this study was to compare the treatment effects of home-based or clinic-based bilateral training with and without mirror feedback programon on physiological markers, sensorimotor, cognition, daily functions, and participation among patients with chronic stroke.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

24

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Taiwan
      • Kaohsiung County, Taiwan
        • Chang Gung Memorial Hospital
      • Taoyuan County, Taiwan
        • Chang Gung Memorial Hospital

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

20 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • The most recent stroke was between 1 month and 5 years
  • No serious cognitive impairment (MMSE≥21)
  • FMA score =18-62
  • No serious muscle spasticity in shoulder, elbow, wrist and finger (MAS≤3)
  • Modified rankin Scale=2 to 4

Exclusion Criteria:

  • Aphasia that might interfere with understanding instructions
  • Stroke in areas other than the brain and brainstem, such as the cerebellum
  • other neurological disease, such as dementia
  • Muscle and joint have serious pain and inflammatory swelling in affected side.
  • Cannot control hypertension, heart disease and serious throbosis

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: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Home-based

Participants in home-based training graoup will receive 1.5 hours/ day, 3 days a week, for 4 contious weeks at home. Participants will receive 2 training stages, including bilateral training with mirror feedback for 30-45 minutes and functional training for 45-60 minutes. Each training stage hase to include above 2 activities.After the end of the home-based training, a four-week wash-out period followed. Then, patients will receive the clinic-based training for 4 continuous weeks.

Before and after the treatment, a total of 4 evaluations were conducted, including clinical assessments and blood test (each 9c.c.). One month after the end of the course of treatment will be assessed.
Atferdsmessig: bilateral training with and without mirror feedback
Aktiv komparator: Clinic-based

Participants in clinic-based training graoup will receive 1.5 hours/ day, 3 days a week, for 4 contious weeks at home. Participants will receive 2 training stages, including bilateral training with mirror feedback for 30-45 minutes and functional training for 45-60 minutes. Each training stage hase to include above 2 activities.After the end of the clinic-based training, a four-week wash-out period followed. Then, patients will receive the home-based training for 4 continuous weeks.

Before and after the treatment, a total of 4 evaluations were conducted, including clinical assessments and blood test (each 9c.c.). One month after the end of the course of treatment will be assessed.
Atferdsmessig: bilateral training with and without mirror feedback

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Fugl-Myer Assessment, FMA
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
Mini-Mental State Exam, MMSE
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention
Change from baseline up to 4 weeks immediately after the completion of intervention
pinch and grasp dynamometer
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
Modified Ashworth Scale, MAS
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
Revised Nottingham Sensory Assessment
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention
Change from baseline up to 4 weeks immediately after the completion of intervention
10-Meter Walking Test, 10MWT
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention
Change from baseline up to 4 weeks immediately after the completion of intervention
Box and Block Test, BBT
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention
Change from baseline up to 4 weeks immediately after the completion of intervention
Wolf Motor Function Test, WMFT
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention
Change from baseline up to 4 weeks immediately after the completion of intervention
Chedoke Arm and Hand Activity Inventory
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention
Change from baseline up to 4 weeks immediately after the completion of intervention
Canadian Occupational Performance Measure, COPM
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention
Change from baseline up to 4 weeks immediately after the completion of intervention
Nottingham Extended Activities of Daily Living, NEADL
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
ABILHAND Questionnaire
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
Motor Activity Log, MAL
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
Actigraphy
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention
Change from baseline up to 4 weeks immediately after the completion of intervention
Stroke Impact Scale, SIS
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
The World Health Organization Quality of Life -Brief version, WHOQOL-BRE
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention
Change from baseline up to 4 weeks immediately after the completion of intervention
Medical Research Council scale,MRC
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention
Change from baseline up to 4 weeks immediately after the completion of intervention
6 minute walk test
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention
Change from baseline up to 4 weeks immediately after the completion of intervention
The Euroqol Quality of Life Scale
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
Lawton-Brody IADL Scale
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention
Change from baseline up to 4 weeks immediately after the completion of intervention
Pittsburg Sleep Quality Index
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.

Sekundære resultatmål

Resultatmål
Tidsramme
Montreal Cognitive Assessment, MoCA
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention
Change from baseline up to 4 weeks immediately after the completion of intervention
Minnesota Rate of Manipulation Test during dual Task
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention
Change from baseline up to 4 weeks immediately after the completion of intervention
Stroop Test
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention
Change from baseline up to 4 weeks immediately after the completion of intervention
Movement Imagery Questionnaire- Revised, Second Edition, MIQ-RS
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention
Change from baseline up to 4 weeks immediately after the completion of intervention
Kinesthetic and Visual Imagery Questionnaire-10, KVIQ-10
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention
Change from baseline up to 4 weeks immediately after the completion of intervention
Modified Rankin Scale, mRS
Tidsramme: baseline
baseline
30 second sit-to-stand test
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention
Change from baseline up to 4 weeks immediately after the completion of intervention
Timed up and go test
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention
Change from baseline up to 4 weeks immediately after the completion of intervention
The stroke self-efficacy questionnaire
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention
Change from baseline up to 4 weeks immediately after the completion of intervention
BDI-II，Beck Depression Inventory II
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention
Change from baseline up to 4 weeks immediately after the completion of intervention

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Chang Gung Memorial Hospital

Publikasjoner og nyttige lenker

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Generelle publikasjoner

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

1. september 2014

Primær fullføring (Faktiske)

12. april 2017

Studiet fullført (Faktiske)

12. april 2017

Datoer for studieregistrering

Først innsendt

14. januar 2015

Først innsendt som oppfylte QC-kriteriene

10. februar 2015

Først lagt ut (Anslag)

18. februar 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

19. mai 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. mai 2017

Sist bekreftet

1. november 2016

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 103-3962A3

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. .

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