Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-02-19 @ 2:52 PM
Study NCT ID:
NCT03579992
Status:
COMPLETED
Last Update Posted:
2019-09-04
First Post:
2018-06-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Myoelectric Computer Interface to Reduce Muscle Co-activation After 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Occupational Therapists were blinded to intervention group'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'lastUpdateSubmitDate': '2019-08-30', 'studyFirstSubmitDate': '2018-06-28', 'studyFirstSubmitQcDate': '2018-07-05', 'lastUpdatePostDateStruct': {'date': '2019-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Modified Ashworth Scale', 'timeFrame': '6 and 10 weeks'}], 'primaryOutcomes': [{'measure': 'Fugl-Meyer Assessment - Upper Extremity', 'timeFrame': '6 weeks', 'description': 'Scale 0-66, total score'}], 'secondaryOutcomes': [{'measure': 'Fugl-Meyer Assessment - Upper Extremity', 'timeFrame': '10 weeks', 'description': 'Scale 0-66, total score'}, {'measure': 'Wolf Motor Function Test', 'timeFrame': '6 and 10 weeks', 'description': 'Timed test'}, {'measure': 'Motor Activity Log', 'timeFrame': '6 and 10 weeks', 'description': '30-question test, total score'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '30888251', 'type': 'RESULT', 'citation': 'Mugler EM, Tomic G, Singh A, Hameed S, Lindberg EW, Gaide J, Alqadi M, Robinson E, Dalzotto K, Limoli C, Jacobson T, Lee J, Slutzky MW. Myoelectric Computer Interface Training for Reducing Co-Activation and Enhancing Arm Movement in Chronic Stroke Survivors: A Randomized Trial. Neurorehabil Neural Repair. 2019 Apr;33(4):284-295. doi: 10.1177/1545968319834903. Epub 2019 Mar 19.'}, {'pmid': '35778757', 'type': 'DERIVED', 'citation': 'Seo G, Kishta A, Mugler E, Slutzky MW, Roh J. Myoelectric interface training enables targeted reduction in abnormal muscle co-activation. J Neuroeng Rehabil. 2022 Jul 1;19(1):67. doi: 10.1186/s12984-022-01045-z.'}]}, 'descriptionModule': {'briefSummary': 'This study examines whether in-lab training with a myoelectric-computer interface (MyCI) can reduce abnormal muscle co-activation after stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stroke survivors at least 6 months after stroke onset\n* Persistent moderate to severe arm impairment\n* Increased arm tone\n\nExclusion Criteria:\n\n* Substantial impairment of vision, memory, language or concentration\n* Botulinum toxin use in the affected arm\n* Concomitant participation in another research study on the arm'}, 'identificationModule': {'nctId': 'NCT03579992', 'briefTitle': 'Myoelectric Computer Interface to Reduce Muscle Co-activation After Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Myoelectric Computer Interface to Reduce Muscle Co-activation After Stroke', 'orgStudyIdInfo': {'id': 'STU00042554'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '60-minute Isometric', 'description': '60-min Isometric MyCI training: EMG-controlled game training for 60-minutes per session', 'interventionNames': ['Behavioral: 60-min isometric MyCI training']}, {'type': 'EXPERIMENTAL', 'label': '90-minute Isometric', 'description': '90-min Isometric MyCI training: EMG-controlled game training for 90-minutes per session', 'interventionNames': ['Behavioral: 90-min isometric MyCI training']}, {'type': 'EXPERIMENTAL', 'label': '90-minute Movement', 'description': '90-min movement MyCI training: EMG-controlled game training for 90-minutes per session', 'interventionNames': ['Behavioral: 90-min movement MyCI training']}], 'interventions': [{'name': '60-min isometric MyCI training', 'type': 'BEHAVIORAL', 'description': 'EMG-controlled in-lab training with arm restrained for 60 minutes per session', 'armGroupLabels': ['60-minute Isometric']}, {'name': '90-min isometric MyCI training', 'type': 'BEHAVIORAL', 'description': 'EMG-controlled in-lab training with arm restrained for 90 minutes per session', 'armGroupLabels': ['90-minute Isometric']}, {'name': '90-min movement MyCI training', 'type': 'BEHAVIORAL', 'description': 'EMG-controlled in-lab training without restraint for 90 minutes per session', 'armGroupLabels': ['90-minute Movement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Marc Slutzky, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Neurology', 'investigatorFullName': 'Marc Slutzky', 'investigatorAffiliation': 'Northwestern University'}}}}