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

17. Mai 2017 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Chronischer Schlaganfall

Intervention / Behandlung

Verhalten: bilateral training with and without mirror feedback

Studientyp

Interventionell

Einschreibung (Tatsächlich)

Phase

Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

20 Jahre bis 80 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Hauptzweck: Behandlung
Zuteilung: Zufällig
Interventionsmodell: Crossover-Aufgabe
Maskierung: Single

Anzahl der Arme

Waffen und Interventionen

Teilnehmergruppe / Arm	Intervention / Behandlung
Experimental: 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.	Verhalten: bilateral training with and without mirror feedback
Aktiver 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.	Verhalten: bilateral training with and without mirror feedback

Teilnehmergruppe / Arm

Intervention / Behandlung

Experimental: 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.

Verhalten: bilateral training with and without mirror feedback

Aktiver 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.

Verhalten: bilateral training with and without mirror feedback

Was misst die Studie?

Primäre Ergebnismessungen

Sekundäre Ergebnismessungen

Ergebnis Maßnahme	Zeitfenster
Montreal Cognitive Assessment, MoCA Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: baseline	baseline
30 second sit-to-stand test Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Chang Gung Memorial Hospital

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Hsieh YW, Chang KC, Hung JW, Wu CY, Fu MH, Chen CC. Effects of Home-Based Versus Clinic-Based Rehabilitation Combining Mirror Therapy and Task-Specific Training for Patients With Stroke: A Randomized Crossover Trial. Arch Phys Med Rehabil. 2018 Dec;99(12):2399-2407. doi: 10.1016/j.apmr.2018.03.017. Epub 2018 Apr 25.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. September 2014

Primärer Abschluss (Tatsächlich)

12. April 2017

Studienabschluss (Tatsächlich)

12. April 2017

Studienanmeldedaten

Zuerst eingereicht

14. Januar 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. Februar 2015

Zuerst gepostet (Schätzen)

18. Februar 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

19. Mai 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

17. Mai 2017

Zuletzt verifiziert

1. November 2016

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

103-3962A3

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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Vereinigte Staaten

Ergebnis Maßnahme	Zeitfenster
Fugl-Myer Assessment, FMA Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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.

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