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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Stroke

Intervention / Treatment
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* Behavioral: bilateral training with and without mirror feedback


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home-based<br>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. | Behavioral: bilateral training with and without mirror feedback<br> <br> |
| Active Comparator: Clinic-based<br>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. | Behavioral: bilateral training with and without mirror feedback<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| Mini-Mental State Exam, MMSE |  | Change from baseline up to 4 weeks immediately 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. | 
| 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. | 
| Revised Nottingham Sensory Assessment |  | 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 | 
| Box and Block Test, BBT |  | 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 | 
| 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. | 
| 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. | 
| 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. | 
| Actigraphy |  | Change from baseline up to 4 weeks immediately 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 World Health Organization Quality of Life -Brief version, WHOQOL-BRE |  | Change from baseline up to 4 weeks immediately after the completion of intervention | 
| Medical Research Council scale,MRC |  | 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 | 
| 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. | 
| Lawton-Brody IADL Scale |  | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Stroop 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 | 
| Kinesthetic and Visual Imagery Questionnaire-10, KVIQ-10 |  | 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 | 
| The stroke self-efficacy questionnaire |  | 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 |