Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 10:51 PM
Study NCT ID:
NCT01684267
Status:
TERMINATED
Last Update Posted:
2019-04-05
First Post:
2012-09-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pelvic Obliquity Rehabilitation in Stroke Patients Using Robotically Generated Force Fields
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': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'whyStopped': 'Lack of funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-03', 'studyFirstSubmitDate': '2012-09-10', 'studyFirstSubmitQcDate': '2012-09-10', 'lastUpdatePostDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pelvic obliquity', 'timeFrame': '1 day', 'description': 'Change in pelvic obliquity during gait consequent to force application'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stroke', 'Gait', 'Rehabilitation'], 'conditions': ['Gait Re-training in Healthy Subjects', 'Gait Re-training in Stroke Survivors']}, 'descriptionModule': {'briefSummary': 'To test the usability and effectiveness of a robotic device, called the Robotic Gait Rehabilitation (RGR) Trainer, in (1) healthy subjects with no gait impairment and (2) patients with stroke with gait abnormalities secondary to impaired knee function.', 'detailedDescription': "The device is designed to train stroke patients to correct abnormal gait patterns associated with exaggerated and uncoordinated movements of the pelvis by applying force fields to correct the movement of the pelvis. The focus will be on correcting hip hiking (i.e. exaggerated unilateral upward movements of one side of the pelvis) in post-stroke patients. The human-robot interface will be based on impedance control techniques so that the force-field actuators generate smooth virtual spring/damper restitution forces at the patient's pelvic area.\n\nAs part of the study we will determine whether the force fields applied by the actuated components of the device can effect an acute change in gait biomechanics, primarily pelvis motion during stance and swing phases, in healthy subjects and patients with stroke during ambulation. The investigators will also evaluate the usability of the orthosis in terms of donning \\& doffing, user confidence, and comfort."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'HEALTHY\n\nInclusion Criteria:\n\n* Can walk comfortably on a treadmill\n\nExclusion Criteria:\n\n* any known orthopedic, musculoskeletal, neurological, cardiovascular, pulmonary, or gait disorder that results in an abnormal gait pattern\n* Females in the second or third trimester of pregnancy\n\nSTROKE\n\nInclusion Criteria:\n\n* single non-traumatic ischemic or hemorrhagic stroke at least 6 months prior to enrollment\n* persistent hemiparesis, mild spasticity, and residual mild-to-moderate weakness of the lower extremity\n* residual deficits of gait\n* be able to ambulate without the use of assistive devices or assistance of a person\n* able to walk at a comfortable walking speed of \\~0.6 m/s\n* able to walk safely on a treadmill\n* medically stable\n* No other neurological problems, or any known cardiovascular or musculoskeletal disorders that effects their gait or excludes them from exercise\n\nExclusion Criteria:\n\n* unable to attend and follow instructions\n* require physical assistance for ambulation\n* other known orthopedic, musculoskeletal, neurological, cardiovascular, pulmonary, or gait disorder that results in an abnormal gait pattern\n* severe joint contractures of the hemi-paretic knee\n* females in the second or third trimester of pregnancy'}, 'identificationModule': {'nctId': 'NCT01684267', 'briefTitle': 'Pelvic Obliquity Rehabilitation in Stroke Patients Using Robotically Generated Force Fields', 'organization': {'class': 'OTHER', 'fullName': 'Spaulding Rehabilitation Hospital'}, 'officialTitle': 'Pelvic Obliquity Rehabilitation in Stroke Patients Using Robotically Generated Force Fields', 'orgStudyIdInfo': {'id': '2009-P-000447'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy', 'description': 'Healthy individuals', 'interventionNames': ['Device: Robotic Gait Rehabilitation (RGR) Trainer']}, {'type': 'EXPERIMENTAL', 'label': 'Post-stroke', 'description': 'Chronic stroke survivors', 'interventionNames': ['Device: Robotic Gait Rehabilitation (RGR) Trainer']}], 'interventions': [{'name': 'Robotic Gait Rehabilitation (RGR) Trainer', 'type': 'DEVICE', 'armGroupLabels': ['Healthy', 'Post-stroke']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02129', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Spaulding Rehabilitation Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spaulding Rehabilitation Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Northeastern University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Motion Analysis Laboratory', 'investigatorFullName': 'Paolo Bonato', 'investigatorAffiliation': 'Spaulding Rehabilitation Hospital'}}}}