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

17 mei 2017 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

24

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

20 jaar tot 80 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: bilateral training with and without mirror feedback
Actieve vergelijker: 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.
Gedragsmatig: bilateral training with and without mirror feedback

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Fugl-Myer Assessment, FMA
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Montreal Cognitive Assessment, MoCA
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: baseline
baseline
30 second sit-to-stand test
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Chang Gung Memorial Hospital

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 september 2014

Primaire voltooiing (Werkelijk)

12 april 2017

Studie voltooiing (Werkelijk)

12 april 2017

Studieregistratiedata

Eerst ingediend

14 januari 2015

Eerst ingediend dat voldeed aan de QC-criteria

10 februari 2015

Eerst geplaatst (Schatting)

18 februari 2015

Updates van studierecords

Laatste update geplaatst (Werkelijk)

19 mei 2017

Laatste update ingediend die voldeed aan QC-criteria

17 mei 2017

Laatst geverifieerd

1 november 2016

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 103-3962A3

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