Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2026-03-02 @ 12:14 AM
Study NCT ID:
NCT00635661
Status:
COMPLETED
Last Update Posted:
2012-03-02
First Post:
2008-03-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assessment of the Stroke Rehabilitation Assessment of Movement as a Clinical Tool
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Irene.ward@nyumc.org', 'phone': '212-263-6073', 'title': 'Dr. Irene Ward', 'organization': 'New York University,. Rusk Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Study Participants', 'description': 'The study participants comprise the cohort on whom data are collected. All participants received usual rehabilitation care following admission. No experimental intervention(s) were provided.', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Stroke Rehabilitation Assessment of Movement (STREAM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Participants', 'description': 'The study participants comprise the cohort on whom data are collected. All participants received usual rehabilitation care following admission. No experimental intervention(s) were provided.'}], 'classes': [{'categories': [{'measurements': [{'value': '73.1', 'spread': '26.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'The STREAM measures quality of movements in the arm and leg, and the quality of mobility during important functional tasks, such as walking 10 feet. There are 10 items for each of the 3 assessments (arm, leg and mobility), resulting in a total of 30 items. Each item is rated on a scale of 0 = unable to perform, to 2 or 3 = normal movement. Ratings on the 30 items are added together for a total score which is divided by the total number of items resulting in a percentage score: minimum=0, maximum=100, range=100 The score reported is mean +/- standard deviation of discharge STREAM scores.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '34 participants were enrolled, 4 participants were dropped from the study resulting in 30 participants providing data for analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Study Participants', 'description': 'The study participants comprise the cohort on whom data are collected. All participants received usual rehabilitation care following admission. No experimental intervention(s) were provided.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Study Participants', 'description': 'The study participants comprise the cohort on whom data are collected. All participants received usual rehabilitation care following admission. No experimental intervention(s) were provided.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.1', 'spread': '15.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-31', 'studyFirstSubmitDate': '2008-03-07', 'resultsFirstSubmitDate': '2011-08-09', 'studyFirstSubmitQcDate': '2008-03-07', 'lastUpdatePostDateStruct': {'date': '2012-03-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-01-31', 'studyFirstPostDateStruct': {'date': '2008-03-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stroke Rehabilitation Assessment of Movement (STREAM)', 'timeFrame': '4 weeks', 'description': 'The STREAM measures quality of movements in the arm and leg, and the quality of mobility during important functional tasks, such as walking 10 feet. There are 10 items for each of the 3 assessments (arm, leg and mobility), resulting in a total of 30 items. Each item is rated on a scale of 0 = unable to perform, to 2 or 3 = normal movement. Ratings on the 30 items are added together for a total score which is divided by the total number of items resulting in a percentage score: minimum=0, maximum=100, range=100 The score reported is mean +/- standard deviation of discharge STREAM scores.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['function', 'disability'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'The Stroke Rehabilitation Assessment of Movement (STREAM) is a relatively new measurement tool, which measures specific movement deficits (impairments) caused by a stroke. The STREAM is used to evaluate recovery of voluntary movement and basic mobility following the onset of a stroke. Several important clinical measurement properties of the STREAM remain to be explored, including its ability to measure impairments and clinical change in acute rehabilitation patients in the USA. We hypothesize that the STREAM will be able to detect and quantify a statistically significant change in the motor abilities of stroke patients from admission to discharge. An additional aim of the study is to compare the STREAM with two accepted and widely used clinical measures of function and disability, the Stroke Impact Scale (SIS)and the Functional Independence Measure (FIM). By linking movement deficits that are commonly assessed by physical therapists with measures of function and disability, the impact of the movement deficits can be understood.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults who have sustained an ischemic stroke', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* comprehension of English\n* age 18 and older\n* first-time stroke\n* receiving in-patient rehabilitation at the Rusk Institute of Rehabilitation Medicine, New York, NY\n\nExclusion Criteria:\n\n* hemorrhagic stroke\n* brain stem or cerebellar infarct\n* other pre-existing neurologic conditions'}, 'identificationModule': {'nctId': 'NCT00635661', 'briefTitle': 'Assessment of the Stroke Rehabilitation Assessment of Movement as a Clinical Tool', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York - Upstate Medical University'}, 'officialTitle': 'A Comparison of the Stroke Rehabilitation Assessment of Movement, the Functional Independence Measure and the Stroke Impact Scale', 'orgStudyIdInfo': {'id': 'IRBPHS-5535'}}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Rusk Institute of Rehabilitation Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Irene Ward, DPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Medical Center, Rusk Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York - Upstate Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'NYU Langone Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Gary Brooks', 'investigatorAffiliation': 'State University of New York - Upstate Medical University'}}}}