Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2025-12-27 @ 12:02 PM
Study NCT ID:
NCT03428659
Status:
COMPLETED
Last Update Posted:
2023-03-01
First Post:
2018-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Recovery Changes in Subacute Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-27', 'studyFirstSubmitDate': '2018-02-04', 'studyFirstSubmitQcDate': '2018-02-04', 'lastUpdatePostDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mechanism of recovery of motor function according to recovery of sub-acute stroke', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'Mechanism of recovery of motor function calculate by repeated measurement method in physical and cognitive functions data and MRI data of brain'}, {'measure': 'Mechanism of recovery of gait function according to recovery of sub-acute stroke', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'Mechanism of recovery of motor function calculate by repeated measurement method in 3D motion capture system and electromyography (EMG) data and MRI data of brain'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Motor function', 'Recovery', 'Gait', 'Magnetic resonance imaging'], 'conditions': ['Sub-acute Stroke']}, 'descriptionModule': {'briefSummary': 'In subacute stroke patients, dynamic time series data of brain imaging and motor function measurement were obtained from 7 days to 6 months (total 9 times) after stroke onset'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A person who was inpatient at sub-acute stage at the Samsung Medical Center.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least 19 years of age hemiplegic stroke patients\n* Subacute-phase ischemic or hemorrhagic stroke patients within 7 days of onset\n* Functional Ambulation Category Scale (FAC) of 3 or less, 7 days of onset,\n* A person who understands and voluntarily participates in this study and signs a research agreement\n\nExclusion Criteria:\n\n* User of artificial heartbeat\n* Patients with claustrophobia\n* Patients with metal implants\n* Patients who are contraindicated for other common MRI\n* Patients with mild motor impairment with an FMA score of 80 or higher\n* Patients whose conscious state is coma and who have no response at all\n* Patients who can not independently gait with the Modified Rankin Scale (mRS) score of 4 or more before the onset of disease'}, 'identificationModule': {'nctId': 'NCT03428659', 'briefTitle': 'Functional Recovery Changes in Subacute Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Dynamic Time Series Data Collection for Functional Recovery Changes in Sub-acute Stroke Patients', 'orgStudyIdInfo': {'id': '2017-11-081'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sub-acute stroke', 'description': 'More than 1 week post-stroke Ischemic or hemorrhagic stroke', 'interventionNames': ['Other: Data acquisition of functional abilities in sub-acute stroke']}], 'interventions': [{'name': 'Data acquisition of functional abilities in sub-acute stroke', 'type': 'OTHER', 'description': 'MRI data, motor evoked potentials, gait function and behavior data acquisition', 'armGroupLabels': ['Sub-acute stroke']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}