Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2026-01-01 @ 4:53 AM
Study NCT ID:
NCT01574495
Status:
COMPLETED
Last Update Posted:
2015-09-24
First Post:
2012-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating Error Augmentation for Neurorehabilitation
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-23', 'studyFirstSubmitDate': '2012-02-28', 'studyFirstSubmitQcDate': '2012-04-08', 'lastUpdatePostDateStruct': {'date': '2015-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Arm motor recovery scores on the Fugl-Meyer', 'timeFrame': 'Change from baseline in Fugl-Meyer to 11 weeks (with assessment periods occurring at 2 weeks, 3 weeks, 4 weeks, 6 weeks, 7 weeks, and 11 weeks for ARM 1; at start of week 1 (pre-eval), end of week 2 (post), and end of week 3 (1 week follow-up) for ARM 2)', 'description': 'Change from baseline in arm motor recovery as measured by Fugl-Meyer'}], 'secondaryOutcomes': [{'measure': 'Number of blocks transferred in Box and Blocks Test', 'timeFrame': 'same as primary', 'description': 'Change from baseline in number of blocks transferred during Box and Blocks Test'}, {'measure': 'Time and Quality of movement scores on the Wolf Motor Function Test', 'timeFrame': 'same as primary', 'description': 'Change from baseline in arm motor recovery as measured by time scores and ability scores on the Wolf Motor Function test'}, {'measure': 'Time scores and Ability scores on the Assessment of Simple Functional Reach Test', 'timeFrame': 'same as primary (not used for ARM 2)', 'description': 'Change from baseline in arm motor recovery as measured by time scores and ability scores on the Assessment of Simple Functional Reach Test'}, {'measure': 'Quantity and Quality with Motor Activity Log', 'timeFrame': 'same as primary but added for ARM 2', 'description': 'Change in baseline of self-reported quantity and quality of functional movements utilizing involved extremity'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stroke', 'error augmentation', 'arm recovery', 'massed practice'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': "This is a sub-project of a larger NIDRR Grant. One promising form of robotic training that leverages the power of neuro-plasticity is error augmentation. In this paradigm the computer singles out and magnifies a stroke survivor's movement errors from a desired trajectory, thus forcing the subjects to strengthen their control. Using the VRROOM, a state-of-the-art system which uses haptics (robotic forces) and graphics (visual display) interfaces, a subject's desired trajectory can be determined and the movement errors can be amplified in real-time with dramatic results. This project evaluates a practical approach of error augmentation, using therapist-driven trajectories. The investigators intend to determine clinical efficacy of several types of therapist-assisted error augmentation on retraining the nervous system in functional activities. The investigators will test two experimental treatments in a crossover design. The investigators hypothesize that combined haptic and visual error augmentation will lead to the best functional recovery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult (age \\>18)\n* survived a single cortical stroke at least 6 months previously involving ischemia or hemorrhage of the middle cerebral artery (MCA),\n* demonstrated the presence of some active shoulder and elbow movement (characterized by Fugl-Meyer Assessment Upper Extremity scores ranging from 15-50 for ARM 1; 25-50 for ARM 2).\n\nExclusion Criteria:\n\n* diffuse or multiple lesion sites or multiple stroke events\n* bilateral paresis\n* severe spasticity or contracture (Modified Ashworth ≥3\n* severe concurrent medical problems\n* severe sensory deficits\n* cerebellar strokes resulting in severe ataxia\n* significant shoulder pain\n* focal tone management with Botulinim Toxin (Botox®) injection to the hemiparetic upper extremity (UE) within the previous four months,\n* aphasia that would influence the ability to perform the experiment\n* cognitive impairment (Mini Mental State Examination \\< 23/30)\n* affective dysfunction that would influence the ability to perform the experiment\n* depth perception impairment (\\< 3 on Stereo Circle Test)\n* visual field cut or hemispatial neglect that would influence the ability to participate in the activity\n* inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT01574495', 'acronym': 'VREA', 'briefTitle': 'Evaluating Error Augmentation for Neurorehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'Shirley Ryan AbilityLab'}, 'officialTitle': 'Evaluating Error Augmentation for Neurorehabilitation', 'orgStudyIdInfo': {'id': 'H133E0700 13'}, 'secondaryIdInfos': [{'id': 'STU00002311', 'type': 'OTHER', 'domain': 'NU IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Error Augmentation-Control', 'interventionNames': ['Other: Error Augmentation']}, {'type': 'EXPERIMENTAL', 'label': 'Control-Error Augmentation', 'interventionNames': ['Other: Error Augmentation']}], 'interventions': [{'name': 'Error Augmentation', 'type': 'OTHER', 'otherNames': ['Error Augmentation-Control', 'Control-Error Augmentation'], 'description': 'error augmentation for arm motor recovery in individuals with stroke', 'armGroupLabels': ['Control-Error Augmentation', 'Error Augmentation-Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rehabilitation Institute of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'James Patton, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shirley Ryan AbilityLab'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shirley Ryan AbilityLab', 'class': 'OTHER'}, 'collaborators': [{'name': 'U.S. Department of Education', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Co-Director, Robotics Laboratory, Sensory Motor Performance Program, Rehabilitation Institute of Chicago', 'investigatorFullName': 'James Patton', 'investigatorAffiliation': 'Shirley Ryan AbilityLab'}}}}