Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2026-01-02 @ 4:09 PM
Study NCT ID:
NCT02364232
Status:
COMPLETED
Last Update Posted:
2017-05-19
First Post:
2015-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Home-based vs. Clinic-based Rehabilitation on Sensorimotor, Cognition, Daily Function, and Participation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-17', 'studyFirstSubmitDate': '2015-01-14', 'studyFirstSubmitQcDate': '2015-02-10', 'lastUpdatePostDateStruct': {'date': '2017-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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.'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Stroke']}, 'referencesModule': {'references': [{'pmid': '29702070', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The most recent stroke was between 1 month and 5 years\n* No serious cognitive impairment (MMSE≥21)\n* FMA score =18-62\n* No serious muscle spasticity in shoulder, elbow, wrist and finger (MAS≤3)\n* Modified rankin Scale=2 to 4\n\nExclusion Criteria:\n\n* Aphasia that might interfere with understanding instructions\n* Stroke in areas other than the brain and brainstem, such as the cerebellum\n* other neurological disease, such as dementia\n* Muscle and joint have serious pain and inflammatory swelling in affected side.\n* Cannot control hypertension, heart disease and serious throbosis'}, 'identificationModule': {'nctId': 'NCT02364232', 'briefTitle': 'Effects of Home-based vs. Clinic-based Rehabilitation on Sensorimotor, Cognition, Daily Function, and Participation', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Effects of Home-based vs. Clinic-based Rehabilitation on Sensorimotor, Cognition, Daily Function, and Participation: Bilateral Training With and Without Mirror Feedback Program', 'orgStudyIdInfo': {'id': '103-3962A3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Home-based', 'description': '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.\n\nBefore 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.', 'interventionNames': ['Behavioral: bilateral training with and without mirror feedback']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Clinic-based', 'description': '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.\n\nBefore 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.', 'interventionNames': ['Behavioral: bilateral training with and without mirror feedback']}], 'interventions': [{'name': 'bilateral training with and without mirror feedback', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Clinic-based', 'Home-based']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kaohsiung County', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital'}, {'city': 'Taoyuan', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital', 'geoPoint': {'lat': 24.99368, 'lon': 121.29696}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}