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

Not Applicable

Completed

• Conditions: Chronic Stroke

• Registration Number: NCT02364232
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-01-14
• Study First Submitted QC: 2015-02-10
• Study First Posted: 2015-02-18
• Status Verified: 2016-11
• Primary Completion: 2017-04-12
• Study Completion: 2017-04-12
• Last Update Submitted: 2017-05-17
• Last Update Posted: 2017-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Mini-Mental State Exam, MMSE	Change from baseline up to 4 weeks immediately after the completion of intervention
Wolf Motor Function Test, WMFT	Change from baseline up to 4 weeks immediately after the completion of intervention
Chedoke Arm and Hand Activity Inventory	Change from baseline up to 4 weeks immediately after the completion of intervention
Motor Activity Log, MAL	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	Change from baseline up to 4 weeks immediately after the completion of intervention
10-Meter Walking Test, 10MWT	Change from baseline up to 4 weeks immediately after the completion of intervention
Actigraphy	Change from baseline up to 4 weeks immediately after the completion of intervention
The World Health Organization Quality of Life -Brief version, WHOQOL-BRE	Change from baseline up to 4 weeks immediately after the completion of intervention
6 minute walk test	Change from baseline up to 4 weeks immediately after the completion of intervention
Pittsburg Sleep Quality Index	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	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	Change from baseline up to 4 weeks immediately after the completion of intervention
ABILHAND Questionnaire	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	Change from baseline up to 4 weeks immediately after the completion of intervention
Fugl-Myer Assessment, FMA	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	Change from baseline up to 4 weeks immediately after the completion of intervention
Modified Ashworth Scale, MAS	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	Change from baseline up to 4 weeks immediately after the completion of intervention
Nottingham Extended Activities of Daily Living, NEADL	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	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	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 Outcome Measures

Name	Time	Method
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
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
Modified Rankin Scale, mRS	baseline

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan County, Taiwan

Chang Gung Memorial Hospital

🇨🇳Taoyuan County, Taiwan