Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 11:45 PM
Study NCT ID:
NCT00037934
Status:
COMPLETED
Last Update Posted:
2011-10-07
First Post:
2002-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Robotic Upper-Limb Neurorehabilitation in Chronic Stroke Patient
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-06', 'studyFirstSubmitDate': '2002-05-24', 'studyFirstSubmitQcDate': '2002-05-24', 'lastUpdatePostDateStruct': {'date': '2011-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Upper limb Motor Status Score, Wolf Motor Function Test, Motor Power Assessment, and Fugl-Meyer Upper Extremity Motor Performance Test', 'timeFrame': 'The Primary Outcome measures were performed at baseline, after completion of 18 sessions of intervention and at 3 months follow-up.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Robot', 'Stroke', 'Upper Extremity'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'We have established the feasibility and effectiveness of robot-aided rehabilitation in stroke patients using a robot for neurological rehabilitation designed and built by MIT. Results of a pilot study of 20 patients were promising and showed that robot therapy is safe, tolerated by patients and produces a significant, measurable benefit. We propose to test that the robotic upper extremity trainer is an acceptable cost effective adjunct to standard occupational therapy for patients with dysfunction of the shoulder and elbow due to hemiparetic stroke in a VA rehabilitation program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic Stroke\n* Manual Muscle Score of Grade 3 or lower in at least one muscle of the affected arm\n\nExclusion Criteria:\n\n* Acute Stroke\n* Contracture or orthopedic problems limiting the movement of the affected arm\n* Visual deficit such that the participant cannot see the test pattern on the robot trainer\n* Serious complicating medical illness\n* Botox treatment to the involved arm within three months of enrollment'}, 'identificationModule': {'nctId': 'NCT00037934', 'briefTitle': 'Robotic Upper-Limb Neurorehabilitation in Chronic Stroke Patient', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Evaluation of Robotic Upper Extremity Neuro-Rehabilitation', 'orgStudyIdInfo': {'id': 'B2436'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Robot exercise group', 'interventionNames': ['Device: Upper extremity robot']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Traditional exercise group', 'interventionNames': ['Device: Upper extremity robot', 'Other: Traditional Supervised Upper Extremity Exercises']}], 'interventions': [{'name': 'Upper extremity robot', 'type': 'DEVICE', 'description': 'Robotic upper extremity neuro-rehabilitation', 'armGroupLabels': ['1', '2']}, {'name': 'Traditional Supervised Upper Extremity Exercises', 'type': 'OTHER', 'description': 'Arm ergometer, reaching, and stretching exercises', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'VA Maryland Health Care System, Baltimore', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Christopher Bever, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Maryland Health Care System, Baltimore'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}, 'collaborators': [{'name': 'Massachusetts Institute of Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}