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Clinical Trials/NCT02364232
NCT02364232
Completed
N/A

Effects of Home-based vs. Clinic-based Rehabilitation on Sensorimotor, Cognition, Daily Function, and Participation: Bilateral Training With and Without Mirror Feedback Program

Chang Gung Memorial Hospital1 site in 1 country24 target enrollmentSeptember 2014
ConditionsChronic Stroke

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Stroke
Sponsor
Chang Gung Memorial Hospital
Enrollment
24
Locations
1
Primary Endpoint
Mini-Mental State Exam, MMSE
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
April 12, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Mini-Mental State Exam, MMSE

Time Frame: Change from baseline up to 4 weeks immediately after the completion of intervention

Wolf Motor Function Test, WMFT

Time Frame: Change from baseline up to 4 weeks immediately after the completion of intervention

Chedoke Arm and Hand Activity Inventory

Time Frame: Change from baseline up to 4 weeks immediately after the completion of intervention

Motor Activity Log, MAL

Time Frame: 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

Time Frame: Change from baseline up to 4 weeks immediately after the completion of intervention

10-Meter Walking Test, 10MWT

Time Frame: Change from baseline up to 4 weeks immediately after the completion of intervention

Actigraphy

Time Frame: Change from baseline up to 4 weeks immediately after the completion of intervention

The World Health Organization Quality of Life -Brief version, WHOQOL-BRE

Time Frame: Change from baseline up to 4 weeks immediately after the completion of intervention

6 minute walk test

Time Frame: Change from baseline up to 4 weeks immediately after the completion of intervention

Pittsburg Sleep Quality Index

Time Frame: 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.

pinch and grasp dynamometer

Time Frame: 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.

Box and Block Test, BBT

Time Frame: Change from baseline up to 4 weeks immediately after the completion of intervention

ABILHAND Questionnaire

Time Frame: 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.

Medical Research Council scale,MRC

Time Frame: Change from baseline up to 4 weeks immediately after the completion of intervention

Fugl-Myer Assessment, FMA

Time Frame: 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

Time Frame: Change from baseline up to 4 weeks immediately after the completion of intervention

Modified Ashworth Scale, MAS

Time Frame: 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.

Canadian Occupational Performance Measure, COPM

Time Frame: Change from baseline up to 4 weeks immediately after the completion of intervention

Nottingham Extended Activities of Daily Living, NEADL

Time Frame: 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.

Stroke Impact Scale, SIS

Time Frame: 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 Euroqol Quality of Life Scale

Time Frame: 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.

Secondary Outcomes

  • Montreal Cognitive Assessment, MoCA(Change from baseline up to 4 weeks immediately after the completion of intervention)
  • Minnesota Rate of Manipulation Test during dual Task(Change from baseline up to 4 weeks immediately after the completion of intervention)
  • Kinesthetic and Visual Imagery Questionnaire-10, KVIQ-10(Change from baseline up to 4 weeks immediately after the completion of intervention)
  • BDI-II,Beck Depression Inventory II(Change from baseline up to 4 weeks immediately after the completion of intervention)
  • Modified Rankin Scale, mRS(baseline)
  • 30 second sit-to-stand test(Change from baseline up to 4 weeks immediately after the completion of intervention)
  • Timed up and go test(Change from baseline up to 4 weeks immediately after the completion of intervention)
  • Movement Imagery Questionnaire- Revised, Second Edition, MIQ-RS(Change from baseline up to 4 weeks immediately after the completion of intervention)
  • Stroop Test(Change from baseline up to 4 weeks immediately after the completion of intervention)
  • The stroke self-efficacy questionnaire(Change from baseline up to 4 weeks immediately after the completion of intervention)

Study Sites (1)

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