Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-26 @ 12:21 PM
Study NCT ID:
NCT01725659
Status:
COMPLETED
Last Update Posted:
2012-11-14
First Post:
2012-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Innovative Modalities for Restoring Upper Limb Function Post 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': 'D012371', 'term': 'Robotics'}], 'ancestors': [{'id': 'D001331', 'term': 'Automation'}, {'id': 'D013672', 'term': 'Technology'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-09', 'studyFirstSubmitDate': '2012-11-09', 'studyFirstSubmitQcDate': '2012-11-09', 'lastUpdatePostDateStruct': {'date': '2012-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fugl Meyer', 'timeFrame': 'after 12 weeks of intervention', 'description': 'impairment measure of coordination of the upper limb'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stroke', 'electric stimulation', 'robotics', 'motor learning'], 'conditions': ['Cerebrovascular Accident']}, 'descriptionModule': {'briefSummary': 'PURPOSE. After stroke many patients are unable to engage in normal upper limb functional activities, which may restrict them from participation in meaningful life roles. For many, conventional rehabilitation does not restore upper limb function to a useful level. The purpose of this research is to investigate the benefits of three promising motor learning interventions: focused intensive, motor learning (FIML); 2) robotics and motor learning (ROB-ML); and 3) functional neuromuscular stimulation and motor learning (FNS-ML).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>1 year post stroke no acute, uncontrolled medical condition single stroke\n\nExclusion Criteria:\n\n* pacemaker other neurological condition more than one stroke'}, 'identificationModule': {'nctId': 'NCT01725659', 'briefTitle': 'Innovative Modalities for Restoring Upper Limb Function Post Stroke', 'organization': {'class': 'FED', 'fullName': 'Malcom Randall VA Medical Center'}, 'officialTitle': 'Innovative Modalities for Restoring Upper Limb Function Post Stroke', 'orgStudyIdInfo': {'id': 'B2801R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Motor Learning', 'description': 'subjects are provided with intensive motor learning training of the upper limb', 'interventionNames': ['Other: Motor Learning']}, {'type': 'EXPERIMENTAL', 'label': 'Robotics and Motor Learning', 'description': 'subject are provided with intensive motor learning and robotics training of the upper limb', 'interventionNames': ['Other: Motor Learning', 'Other: Robotics']}, {'type': 'EXPERIMENTAL', 'label': 'Motor learning and FES', 'description': 'subjects are provided with intensive motor learning and surface FES (Functional Electrical Stimulation) of the upper limb', 'interventionNames': ['Other: Motor Learning', 'Other: surface FES']}], 'interventions': [{'name': 'Motor Learning', 'type': 'OTHER', 'description': 'training of the hemiplegic upper limb with motor learning', 'armGroupLabels': ['Motor Learning', 'Motor learning and FES', 'Robotics and Motor Learning']}, {'name': 'Robotics', 'type': 'OTHER', 'description': 'subjects perform training of hemiplegic arm using an upper extremity robot', 'armGroupLabels': ['Robotics and Motor Learning']}, {'name': 'surface FES', 'type': 'OTHER', 'description': 'subjects are provided with surface FES to the hemiplegic upper limb', 'armGroupLabels': ['Motor learning and FES']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44118', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Louis Stokes Cleveland Department of Veterans Affairs Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Malcom Randall VA Medical Center', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Janis Daly', 'investigatorAffiliation': 'Malcom Randall VA Medical Center'}}}}