Effects of Home-based vs. Clinic-based Rehabilitation on Sensorimotor, Cognition, Daily Function, and Participation
17. maj 2017 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
24
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Kaohsiung County, Taiwan
- Chang Gung Memorial Hospital
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Taoyuan County, Taiwan
- Chang Gung Memorial Hospital
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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
20 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
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: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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. |
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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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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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.
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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.
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Mini-Mental State Exam, MMSE
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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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.
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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.
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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.
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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.
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Revised Nottingham Sensory Assessment
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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10-Meter Walking Test, 10MWT
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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Box and Block Test, BBT
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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Wolf Motor Function Test, WMFT
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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Chedoke Arm and Hand Activity Inventory
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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Canadian Occupational Performance Measure, COPM
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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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.
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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.
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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.
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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.
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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.
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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.
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Actigraphy
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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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.
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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.
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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
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Change from baseline up to 4 weeks immediately after the completion of intervention
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Medical Research Council scale,MRC
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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6 minute walk test
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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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.
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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.
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Lawton-Brody IADL Scale
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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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.
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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.
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Montreal Cognitive Assessment, MoCA
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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Minnesota Rate of Manipulation Test during dual Task
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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Stroop Test
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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Movement Imagery Questionnaire- Revised, Second Edition, MIQ-RS
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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Kinesthetic and Visual Imagery Questionnaire-10, KVIQ-10
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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Modified Rankin Scale, mRS
Tidsramme: baseline
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baseline
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30 second sit-to-stand test
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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Timed up and go test
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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The stroke self-efficacy questionnaire
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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BDI-II，Beck Depression Inventory II
Tidsramme: Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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
1. september 2014
Primær færdiggørelse (Faktiske)
12. april 2017
Studieafslutning (Faktiske)
12. april 2017
Datoer for studieregistrering
Først indsendt
14. januar 2015
Først indsendt, der opfyldte QC-kriterier
10. februar 2015
Først opslået (Skøn)
18. februar 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
19. maj 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. maj 2017
Sidst verificeret
1. november 2016
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 103-3962A3
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 .
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