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

17 maggio 2017 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

24

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 20 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: bilateral training with and without mirror feedback
Comparatore attivo: 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.
Comportamentale: bilateral training with and without mirror feedback

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Fugl-Myer Assessment, FMA
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Montreal Cognitive Assessment, MoCA
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: baseline
baseline
30 second sit-to-stand test
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Chang Gung Memorial Hospital

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 settembre 2014

Completamento primario (Effettivo)

12 aprile 2017

Completamento dello studio (Effettivo)

12 aprile 2017

Date di iscrizione allo studio

Primo inviato

14 gennaio 2015

Primo inviato che soddisfa i criteri di controllo qualità

10 febbraio 2015

Primo Inserito (Stima)

18 febbraio 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

19 maggio 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 maggio 2017

Ultimo verificato

1 novembre 2016

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 103-3962A3

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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