Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-03-03 @ 10:17 AM
Study NCT ID:
NCT02190734
Status:
COMPLETED
Last Update Posted:
2019-04-22
First Post:
2014-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pushing Behaviors in Individuals 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': 'D000077708', 'term': 'Sitting Position'}, {'id': 'D014910', 'term': 'Wheelchairs'}], 'ancestors': [{'id': 'D011187', 'term': 'Posture'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D012656', 'term': 'Self-Help Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-18', 'studyFirstSubmitDate': '2014-05-21', 'studyFirstSubmitQcDate': '2014-07-11', 'lastUpdatePostDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Burke Lateropulsion Scale', 'timeFrame': 'Before and after each of 3 treatment sessions (3 separate days) over a maximum of a 10 day period', 'description': 'Clinical measure of pushing behaviors in supine, sitting, standing, walking, and transfers will be performed before and after each 30 minute training session.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stroke', 'Pusher Syndrome', 'Lateropulsion', 'Pushing Behaviors', 'Burke Lateropulsion Scale'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Some individuals demonstrate pushing behaviors after having a stroke. The purpose of this study is to see if there are immediate changes in pushing behaviors in individuals who have had a stroke before and after sitting in a wheelchair, walking on the treadmill, and walking overground.\n\nThe investigators do not think there will be a change with sitting in the wheelchair, but the investigators think there may be an improvement in pushing behaviors after walking training.', 'detailedDescription': 'The study population of interest is primarily individuals in inpatient rehabilitation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* score \\>0 in each subsection of the Scale for Contraversive Pushing\n* admitted to the Rehabilitation Institute of Chicago inpatient rehabilitation setting\n* stroke within previous 180 days\n* consent to participate in the study\n* ambulating greater than 150' at a time prior to stroke\n\nExclusion Criteria:\n\n* other neurologic diagnoses\n* weight bearing precautions, orthopedic injuries, or other medical co-morbidities that prevent adherence to the study protocol"}, 'identificationModule': {'nctId': 'NCT02190734', 'briefTitle': 'Pushing Behaviors in Individuals Post-stroke', 'organization': {'class': 'OTHER', 'fullName': 'Shirley Ryan AbilityLab'}, 'officialTitle': 'Inpatient Rehabilitation Treatments and Effect on Pushing Behaviors in Individuals Post-stroke', 'orgStudyIdInfo': {'id': 'Pusher1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'wheelchair, walking on treadmill, walking overground', 'description': 'Sitting in wheel chair Gait training on treadmill Gait training overground', 'interventionNames': ['Other: Sitting in wheel chair', 'Other: Gait training on treadmill', 'Other: Gait training overground']}], 'interventions': [{'name': 'Sitting in wheel chair', 'type': 'OTHER', 'description': 'Placebo/control intervention- No treatment, sitting in a wheelchair for 30 minutes', 'armGroupLabels': ['wheelchair, walking on treadmill, walking overground']}, {'name': 'Gait training on treadmill', 'type': 'OTHER', 'description': 'Walking on a treadmill with or without body weight support during 30 minute treatment', 'armGroupLabels': ['wheelchair, walking on treadmill, walking overground']}, {'name': 'Gait training overground', 'type': 'OTHER', 'description': 'Walking overground with or without body weight support during 30 minute treatment', 'armGroupLabels': ['wheelchair, walking on treadmill, walking overground']}]}, 'contactsLocationsModule': {'locations': [{'zip': '96817', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Rehabilitation Hospital of the Pacific', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rehabilitation Institute of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'T. George Hornby, PT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rehabilitation Institute of Chicago, University of Illinois at Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shirley Ryan AbilityLab', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Thomas G Hornby', 'investigatorAffiliation': 'Shirley Ryan AbilityLab'}}}}