Effects of Home-based vs. Clinic-based Rehabilitation on Sensorimotor, Cognition, Daily Function, and Participation
Not Applicable
Completed
- Conditions
- Chronic Stroke
- Interventions
- Behavioral: bilateral training with and without mirror feedback
- 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
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
- Arm && Interventions
Group Intervention Description Home-based bilateral training with and without mirror feedback 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. Clinic-based bilateral training with and without mirror feedback 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.
- Primary Outcome Measures
Name Time Method 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 Mini-Mental State Exam, MMSE 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 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
Trial Locations
- Locations (1)
Chang Gung Memorial Hospital
🇨🇳Taoyuan County, Taiwan