Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2026-01-05 @ 6:37 PM
Study NCT ID:
NCT03468166
Status:
COMPLETED
Last Update Posted:
2023-03-01
First Post:
2018-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Data Collection for Motor Function and Gait Pattern Analysis of Patients With Chronic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-27', 'studyFirstSubmitDate': '2018-03-06', 'studyFirstSubmitQcDate': '2018-03-11', 'lastUpdatePostDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gait analysis', 'timeFrame': '1 hour', 'description': 'Gait analysis is a process of measuring and evaluating the walking patterns of patients by using surface electromyograph and motion analysis system.'}], 'secondaryOutcomes': [{'measure': 'Fugl-Meyer assessment for lower extremity (FMA)', 'timeFrame': '20 minutes', 'description': 'The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment.'}, {'measure': 'The Timed Up and Go test (TUG)', 'timeFrame': '10 minutes', 'description': "The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down."}, {'measure': '10 meter walk test (10MWT)', 'timeFrame': '5 minutes', 'description': 'Measure of self selected speeds by measuring the time it takes an individual to walk 10 meters. To perform the test, patient walks 10 meters (33 ft) and the time is measured when the leading foot crosses the start line and the finish line. The instructions are: "Please walk this distance at your normal pace when I say go."'}, {'measure': 'Manual Muscle Test (MMT)', 'timeFrame': '15 minutes', 'description': 'Manual muscle testing (MMT) is a procedure for the evaluation of the function and strength of individual muscles and muscle groups based on the effective performance of a movement in relation to the forces of gravity and manual resistance.'}, {'measure': 'Range of Motion (ROM)', 'timeFrame': '15 minutes', 'description': 'Range of Motion (ROM) testing is the measurement of movement around a specific joint or body part.'}, {'measure': 'Functional Ambulation Classification (FAC)', 'timeFrame': '10 minutes', 'description': 'The Functional Ambulation Categories (FAC) is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device.'}, {'measure': 'Modified Bathel index (MBI)', 'timeFrame': '10 minutes', 'description': 'The MBI is a measure of activities of daily living, which shows the degree of independence of a patient from any assistance. It covers 10 domains of functioning (activities): bowel control, bladder control, as well as help with grooming, toilet use, feeding, transfers, walking, dressing, climbing stairs, and bathing.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Motor function', 'Gait pattern'], 'conditions': ['Chronic Stroke']}, 'descriptionModule': {'briefSummary': 'In chronic stroke patients, the data for motor function and gait pattern analysis was obtained.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with chronic stroke who can walk outdoors', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stroke patients with hemiplegia over 19 years old\n* Ischemic or hemorrhagic stroke patients over 6 months of onset\n* Functional Ambulation Category Scale with 3 or more scales and a person who can walk independently regardless of using of walking aids\n* A person who understands and voluntarily participates in this study and signs a research agreement\n\nExclusion Criteria:\n\n* Patients of artificial heartbeat\n* Patients with claustrophobia\n* Patients with intracranial metal implants\n* Patients who are contraindicated for other common MRI scans\n* Patients difficult to walk due to problems such as visual field defect, fracture, severe muscle paralysis, cognitive impairment\n* Those who have a score of FMA score of 80 or more and have very slight motor impairment'}, 'identificationModule': {'nctId': 'NCT03468166', 'briefTitle': 'Data Collection for Motor Function and Gait Pattern Analysis of Patients With Chronic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Data Collection for Motor Function and Gait Pattern Analysis of Patients With Chronic Stroke', 'orgStudyIdInfo': {'id': '2018-02-053'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chronic stroke', 'description': 'The data for motor function and gait pattern analysis was obtained.', 'interventionNames': ['Other: Chronic stroke']}], 'interventions': [{'name': 'Chronic stroke', 'type': 'OTHER', 'description': 'The data for motor function and gait pattern analysis was obtained.', 'armGroupLabels': ['Chronic stroke']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}