Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-02-23 @ 8:57 PM
Study NCT ID:
NCT01726660
Status:
WITHDRAWN
Last Update Posted:
2018-02-05
First Post:
2012-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The General Use of Robots in Stroke Recovery
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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Unfunded', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-02', 'studyFirstSubmitDate': '2012-10-26', 'studyFirstSubmitQcDate': '2012-11-09', 'lastUpdatePostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in Upper Extremity Fugl Meyer Motor Assessment', 'timeFrame': '12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Kinematic Data', 'timeFrame': '12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)', 'description': 'Kinematic Data recorded during therapy with IMT robots'}, {'measure': 'Change from baseline in Fugl Meyer Sensation Scale', 'timeFrame': '12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)'}, {'measure': 'Change from baseline in Fugl Meyer Proprioception Scale', 'timeFrame': '12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stroke', 'Cerebrovascular Accident', 'Cerebral stroke', 'CVA', 'robotic therapy', 'upper extremity recovery', 'kinematic training'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '15314537', 'type': 'BACKGROUND', 'citation': 'Stein J, Krebs HI, Frontera WR, Fasoli SE, Hughes R, Hogan N. Comparison of two techniques of robot-aided upper limb exercise training after stroke. Am J Phys Med Rehabil. 2004 Sep;83(9):720-8. doi: 10.1097/01.phm.0000137313.14480.ce.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if tailoring multiple sessions of upper extremity robotic therapy to focus on a particular aspect of movement (e.g smoothness vs. aiming; active range of motion vs. functional practice)can optimize therapeutic results and lead to greater functional returns in arm mobility after stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* First single focal unilateral lesion with diagnosis verified by brain imaging, which occurred at least 6 months prior\n* Cognitive function sufficient enough to understand experiments and follow instructions\n* Fugl Meyer assessment at admission of 7 to 38 out of 66 (neither hemiplegic nor fully recovered motor function in the muscles of the shoulder, elbow, and wrist)\n\nExclusion Criteria:\n\n* Prior experience with robotic arm therapy\n* Fixed contraction of the affected limb\n* Complete flaccid paralysis of the affected limb'}, 'identificationModule': {'nctId': 'NCT01726660', 'briefTitle': 'The General Use of Robots in Stroke Recovery', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'Pilot Study of the Effects of Protocol-Specific Robotic Arm Therapy in Stroke Recovery', 'orgStudyIdInfo': {'id': '11-121B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IMT Robotic Arm Therapy: Aim training', 'description': 'Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for aim training, 3x/week for 12 weeks.', 'interventionNames': ['Device: IMT Robotic Arm therapy']}, {'type': 'EXPERIMENTAL', 'label': 'IMT Robotic Arm Therapy: Smoothness Training', 'description': 'Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for smoothness training, 3x/week for 12 weeks.', 'interventionNames': ['Device: IMT Robotic Arm therapy']}, {'type': 'EXPERIMENTAL', 'label': 'IMT Robotic Arm Therapy: Impairment training', 'description': 'Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for whole-arm, impairment training, 3x/week for 12 weeks.', 'interventionNames': ['Device: IMT Robotic Arm therapy']}, {'type': 'EXPERIMENTAL', 'label': 'IMT Robotic Arm Therapy: Functional training', 'description': 'Alternating sessions of planar (shoulder/elbow) and wrist robotic therapy programmed for whole arm, functional training, 3x/week for 12 weeks.', 'interventionNames': ['Device: IMT Robotic Arm therapy']}], 'interventions': [{'name': 'IMT Robotic Arm therapy', 'type': 'DEVICE', 'description': 'Interactive Motion Technologies (IMT) planar and wrist robots for robotic arm therapy', 'armGroupLabels': ['IMT Robotic Arm Therapy: Aim training', 'IMT Robotic Arm Therapy: Functional training', 'IMT Robotic Arm Therapy: Impairment training', 'IMT Robotic Arm Therapy: Smoothness Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'Feinstein Institute for Medical Research', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}], 'overallOfficials': [{'name': 'Bruce T Volpe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Feinstein Institute for Medical Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Bruce Volpe', 'investigatorAffiliation': 'Northwell Health'}}}}