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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Stroke
• Intervention / Treatment: Behavioral: bilateral training with and without mirror feedback

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: bilateral training with and without mirror feedback
Active Comparator: 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.	Behavioral: bilateral training with and without mirror feedback

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Publications and helpful links

General Publications

• Hsieh YW, Chang KC, Hung JW, Wu CY, Fu MH, Chen CC. Effects of Home-Based Versus Clinic-Based Rehabilitation Combining Mirror Therapy and Task-Specific Training for Patients With Stroke: A Randomized Crossover Trial. Arch Phys Med Rehabil. 2018 Dec;99(12):2399-2407. doi: 10.1016/j.apmr.2018.03.017. Epub 2018 Apr 25.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): April 12, 2017
• Study Completion (Actual): April 12, 2017

Study Registration Dates

• First Submitted: January 14, 2015
• First Submitted That Met QC Criteria: February 10, 2015
• First Posted (Estimate): February 18, 2015

Study Record Updates

• Last Update Posted (Actual): May 19, 2017
• Last Update Submitted That Met QC Criteria: May 17, 2017
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 103-3962A3