Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2026-01-06 @ 9:42 PM
Study NCT ID:
NCT02548234
Status:
COMPLETED
Last Update Posted:
2020-09-03
First Post:
2015-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Mirror Therapy Versus Bilateral Arm Training for Rehabilitation After Chronic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000088762', 'term': 'Mirror Movement Therapy'}], 'ancestors': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2017-10-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-01', 'studyFirstSubmitDate': '2015-09-09', 'studyFirstSubmitQcDate': '2015-09-10', 'lastUpdatePostDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The efficacy of mirror therapy versus bilateral arm training on sensorimotor functions', 'timeFrame': 'within four weeks (plus or minus 3 days) after intervention', 'description': 'Revised Nottingham Sensory Assessment and Fugl-Meyer Assessment will be used to measure sensorimotor functions. The statistical analysis will be performed to compare the significant differences for the efficacy of mirror therapy versus bilateral arm training.'}], 'secondaryOutcomes': [{'measure': 'The efficacy of mirror therapy versus bilateral arm training on motor performance', 'timeFrame': 'within four weeks (plus or minus 3 days) after intervention', 'description': 'The Chedoke Arm and Hand Activity Inventory (CAHAI) will be used to measure arm and hand functions on real-life bilateral tasks. The statistical analysis will be performed to compare the significant differences for the efficacy of mirror therapy versus bilateral arm training on motor performance.'}, {'measure': 'The efficacy of mirror therapy versus bilateral arm training on motor performance', 'timeFrame': 'within four weeks (plus or minus 3 days) after intervention', 'description': 'Motor Activity Log (MAL) will be used to measure self-perceived real-world use. The statistical analysis will be performed to compare the significant differences for the efficacy of mirror therapy versus bilateral arm training.'}, {'measure': 'The efficacy of mirror therapy versus bilateral arm training on quality of life', 'timeFrame': 'within four weeks (plus or minus 3 days) after intervention', 'description': 'Stroke Impact Scale Version 3.0 (SIS) will be used to measure patient reported quality of life and multidimensional stroke recovery. The statistical analysis will be performed to compare the significant differences for the efficacy of mirror therapy versus bilateral arm training.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Stroke', 'Randomized control trial', 'Mirror therapy', 'Bilateral arm training', 'Comparative efficacy research', 'Neurorehabilitation'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '22419334', 'type': 'BACKGROUND', 'citation': 'Thieme H, Mehrholz J, Pohl M, Behrens J, Dohle C. Mirror therapy for improving motor function after stroke. Cochrane Database Syst Rev. 2012 Mar 14;2012(3):CD008449. doi: 10.1002/14651858.CD008449.pub2.'}, {'pmid': '23419791', 'type': 'BACKGROUND', 'citation': 'Wu CY, Huang PC, Chen YT, Lin KC, Yang HW. Effects of mirror therapy on motor and sensory recovery in chronic stroke: a randomized controlled trial. Arch Phys Med Rehabil. 2013 Jun;94(6):1023-30. doi: 10.1016/j.apmr.2013.02.007. Epub 2013 Feb 15.'}, {'pmid': '25064777', 'type': 'BACKGROUND', 'citation': 'Samuelkamaleshkumar S, Reethajanetsureka S, Pauljebaraj P, Benshamir B, Padankatti SM, David JA. Mirror therapy enhances motor performance in the paretic upper limb after stroke: a pilot randomized controlled trial. Arch Phys Med Rehabil. 2014 Nov;95(11):2000-5. doi: 10.1016/j.apmr.2014.06.020. Epub 2014 Jul 23.'}, {'pmid': '24985386', 'type': 'BACKGROUND', 'citation': 'Wolf A, Scheiderer R, Napolitan N, Belden C, Shaub L, Whitford M. Efficacy and task structure of bimanual training post stroke: a systematic review. Top Stroke Rehabil. 2014 May-Jun;21(3):181-96. doi: 10.1310/tsr2103-181.'}]}, 'descriptionModule': {'briefSummary': 'The study purpose is to compare the efficacy of mirror therapy and bilateral arm training on movement strategies of the affected upper extremity and functional outcome in chronic stroke patients.', 'detailedDescription': 'Study background: Approximately 80% of stroke survivors have an upper and/or lower limb impairment (Barker 1997), and impairment of the arm explains up to 50% of the variance in functional limitation after stroke. Brain imaging research using magnetoencephalography found that mirror therapy combined with bilateral arm training could potentially aid stroke rehabilitation by normalizing an asymmetrical pattern of movement-related beta desynchronization in primary motor cortex. However, different neural mechanisms may cause different effect of motor control recovery after the two different approaches, which have yet to be studied. Study purposeļ¼To compare the efficacy of mirror therapy and bilateral arm training on movement strategies of the affected upper extremity and functional outcome in chronic stroke patients. Study method: This was a single-blind, randomized, comparative efficacy research. Sixty participants with chronic stroke will be recruited in the occupational therapy clinics at four hospitals and randomly assigned to the mirror therapy and bilateral arm training groups. The intervention will consist of 1.5 hrs/day, 5 days/wk for 4 wks, including 3 days of hospital-based therapy and 5 days of home practice. Primary outcomes were muscular properties (grip strength) and sensorimotor measurements. Secondary outcomes included measures of daily functions to gain insight about movement capabilities. The validity and reliability of all measurements have been proposed. Finally, the Mann-Whitney U test and the Fisher exact test will be used to compare the significant differences between the two approaches. The effect size of dependent variables will be reported also.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* more than 6 months after onset of an ischemic or hemorrhage stroke\n* no excessive spasticity on all joints of the affected arm\n\nExclusion Criteria:\n\n* history of stroke or other neurologic, neuromuscular, or orthopedic disease\n* participation in other experimental rehabilitation or drug studies concurrent with this study'}, 'identificationModule': {'nctId': 'NCT02548234', 'briefTitle': 'Effect of Mirror Therapy Versus Bilateral Arm Training for Rehabilitation After Chronic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University Hospital'}, 'officialTitle': 'Effect of Mirror Therapy Versus Bilateral Arm Training for Rehabilitation After Chronic Stroke: a Pilot Randomized-controlled Trial', 'orgStudyIdInfo': {'id': 'CMUH104-REC3-052'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mirror therapy', 'description': 'Mirror therapy group received training for 1.5 hours/day, 3 days/week, for 4 weeks and home programs for 30-40 min/day, 5 days/week.', 'interventionNames': ['Other: Mirror therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Bilateral arm training', 'description': 'Bilateral arm training group received training for 1.5 hours/day, 3 days/week, for 4 weeks and home programs for 30-40 min/day, 5 days/week.', 'interventionNames': ['Other: Bilateral arm training']}], 'interventions': [{'name': 'Mirror therapy', 'type': 'OTHER', 'description': 'Mirror therapy group received training for 1.5 hours/day, 3 days/week, for 4 weeks and home programs for 30-40 min/day, 5 days/week.', 'armGroupLabels': ['Mirror therapy']}, {'name': 'Bilateral arm training', 'type': 'OTHER', 'description': 'Bilateral arm training group received training for 1.5 hours/day, 3 days/week, for 4 weeks and home programs for 30-40 min/day, 5 days/week.', 'armGroupLabels': ['Bilateral arm training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '404', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'China Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'overallOfficials': [{'name': 'Keh-Chung Lin, ScD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Medical University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}