Clinical trial NCT02364232: Effects of Home-based vs. Clinic-based Rehabilitation on Sensorimotor, Cognition, Daily Function, and Participation
Official title: Effects of Home-based vs. Clinic-based Rehabilitation on Sensorimotor, Cognition, Daily Function, and Participation: Bilateral Training With and Without Mirror Feedback Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Stroke
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2015-02-18
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Fugl-Myer Assessment, FMA
timeFrame: 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.
measure: Mini-Mental State Exam, MMSE
timeFrame: Change from baseline up to 4 weeks immediately after the completion of intervention
measure: pinch and grasp dynamometer
timeFrame: 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.
measure: Modified Ashworth Scale, MAS
timeFrame: 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.
measure: Revised Nottingham Sensory Assessment
timeFrame: Change from baseline up to 4 weeks immediately after the completion of intervention
measure: 10-Meter Walking Test, 10MWT
timeFrame: Change from baseline up to 4 weeks immediately after the completion of intervention
measure: Box and Block Test, BBT
timeFrame: Change from baseline up to 4 weeks immediately after the completion of intervention
measure: Wolf Motor Function Test, WMFT
timeFrame: Change from baseline up to 4 weeks immediately after the completion of intervention
measure: Chedoke Arm and Hand Activity Inventory
timeFrame: Change from baseline up to 4 weeks immediately after the completion of intervention
measure: Canadian Occupational Performance Measure, COPM
timeFrame: Change from baseline up to 4 weeks immediately after the completion of intervention
measure: Nottingham Extended Activities of Daily Living, NEADL
timeFrame: 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.
measure: ABILHAND Questionnaire
timeFrame: 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.
measure: Motor Activity Log, MAL
timeFrame: 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.
measure: Actigraphy
timeFrame: Change from baseline up to 4 weeks immediately after the completion of intervention
measure: Stroke Impact Scale, SIS
timeFrame: 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.
measure: The World Health Organization Quality of Life -Brief version, WHOQOL-BRE
timeFrame: Change from baseline up to 4 weeks immediately after the completion of intervention
measure: Medical Research Council scale,MRC
timeFrame: Change from baseline up to 4 weeks immediately after the completion of intervention
measure: 6 minute walk test
timeFrame: Change from baseline up to 4 weeks immediately after the completion of intervention
measure: The Euroqol Quality of Life Scale
timeFrame: 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.
measure: Lawton-Brody IADL Scale
timeFrame: Change from baseline up to 4 weeks immediately after the completion of intervention
measure: Pittsburg Sleep Quality Index
timeFrame: 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:
measure: Montreal Cognitive Assessment, MoCA
timeFrame: Change from baseline up to 4 weeks immediately after the completion of intervention
measure: Minnesota Rate of Manipulation Test during dual Task
timeFrame: Change from baseline up to 4 weeks immediately after the completion of intervention
measure: Stroop Test
timeFrame: Change from baseline up to 4 weeks immediately after the completion of intervention
measure: Movement Imagery Questionnaire- Revised, Second Edition, MIQ-RS
timeFrame: Change from baseline up to 4 weeks immediately after the completion of intervention
measure: Kinesthetic and Visual Imagery Questionnaire-10, KVIQ-10
timeFrame: Change from baseline up to 4 weeks immediately after the completion of intervention
measure: Modified Rankin Scale, mRS
timeFrame: baseline
measure: 30 second sit-to-stand test
timeFrame: Change from baseline up to 4 weeks immediately after the completion of intervention
measure: Timed up and go test
timeFrame: Change from baseline up to 4 weeks immediately after the completion of intervention
measure: The stroke self-efficacy questionnaire
timeFrame: Change from baseline up to 4 weeks immediately after the completion of intervention
measure: BDI-II，Beck Depression Inventory II
timeFrame: Change from baseline up to 4 weeks immediately after the completion of intervention
Other outcomes:
Locations:
city: Kaohsiung County
country: Taiwan
facility: Chang Gung Memorial Hospital
city: Taoyuan County
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
References:
citation: 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.