Effects of Home-based vs. Clinic-based Rehabilitation on Sensorimotor, Cognition, Daily Function, and Participation
17. května 2017 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
24
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Kaohsiung County, Tchaj-wan
- Chang Gung Memorial Hospital
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Taoyuan County, Tchaj-wan
- Chang Gung Memorial Hospital
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
20 let až 80 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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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Aktivní komparátor: 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
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Fugl-Myer Assessment, FMA
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Montreal Cognitive Assessment, MoCA
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: baseline
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baseline
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30 second sit-to-stand test
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. září 2014
Primární dokončení (Aktuální)
12. dubna 2017
Dokončení studie (Aktuální)
12. dubna 2017
Termíny zápisu do studia
První předloženo
14. ledna 2015
První předloženo, které splnilo kritéria kontroly kvality
10. února 2015
První zveřejněno (Odhad)
18. února 2015
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
19. května 2017
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
17. května 2017
Naposledy ověřeno
1. listopadu 2016
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 103-3962A3
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .