NCT Number: NCT02364232
Effects of Home-based vs. Clinic-based Rehabilitation on Sensorimotor, Cognition, Daily Function, and Participation
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.
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Notify MeKey information
Conditions
Age range
20 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Chang Gung Memorial Hospital, Kaohsiung County, Taiwan
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
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Fugl-Myer Assessment, FMA
Time frame: 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.
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Mini-Mental State Exam, MMSE
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
-
pinch and grasp dynamometer
Time frame: 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
Time frame: 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
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
-
10-Meter Walking Test, 10MWT
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
-
Box and Block Test, BBT
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
-
Wolf Motor Function Test, WMFT
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
-
Chedoke Arm and Hand Activity Inventory
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
-
Canadian Occupational Performance Measure, COPM
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
-
Nottingham Extended Activities of Daily Living, NEADL
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
-
Stroke Impact Scale, SIS
Time frame: 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
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
-
Medical Research Council scale,MRC
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
-
6 minute walk test
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
-
The Euroqol Quality of Life Scale
Time frame: 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
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
-
Pittsburg Sleep Quality Index
Time frame: 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
-
Montreal Cognitive Assessment, MoCA
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
-
Minnesota Rate of Manipulation Test during dual Task
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
-
Stroop Test
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
-
Movement Imagery Questionnaire- Revised, Second Edition, MIQ-RS
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
-
Kinesthetic and Visual Imagery Questionnaire-10, KVIQ-10
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
-
Modified Rankin Scale, mRS
Time frame: baseline
-
30 second sit-to-stand test
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
-
Timed up and go test
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
-
The stroke self-efficacy questionnaire
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
-
BDI-II,Beck Depression Inventory II
Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention
Sponsors and collaborators
Lead sponsor
Chang Gung Memorial Hospital
Other
Registry information
Official study title
Effects of Home-based vs. Clinic-based Rehabilitation on Sensorimotor, Cognition, Daily Function, and Participation: Bilateral Training With and Without Mirror Feedback Program
Important dates
- Study start
- 2014
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Feb 18, 2015
- Registry last updated
- May 19, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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