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

17 maja 2017 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

24

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

20 lat do 80 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie krzyżowe
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: bilateral training with and without mirror feedback
Aktywny 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.
Behawioralne: bilateral training with and without mirror feedback

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Ramy czasowe
Fugl-Myer Assessment, FMA
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.

Miary wyników drugorzędnych

Miara wyniku
Ramy czasowe
Montreal Cognitive Assessment, MoCA
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: baseline
baseline
30 second sit-to-stand test
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Chang Gung Memorial Hospital

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 września 2014

Zakończenie podstawowe (Rzeczywisty)

12 kwietnia 2017

Ukończenie studiów (Rzeczywisty)

12 kwietnia 2017

Daty rejestracji na studia

Pierwszy przesłany

14 stycznia 2015

Pierwszy przesłany, który spełnia kryteria kontroli jakości

10 lutego 2015

Pierwszy wysłany (Oszacować)

18 lutego 2015

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

19 maja 2017

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

17 maja 2017

Ostatnia weryfikacja

1 listopada 2016

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • 103-3962A3

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Przewlekły udar

Badania kliniczne na bilateral training with and without mirror feedback

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