Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-03-07 @ 10:58 PM
Study NCT ID:
NCT02694302
Status:
COMPLETED
Last Update Posted:
2016-09-27
First Post:
2016-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of Robot-assisted-gait-training (RAGT) in Stroke Patients
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-26', 'studyFirstSubmitDate': '2016-02-18', 'studyFirstSubmitQcDate': '2016-02-26', 'lastUpdatePostDateStruct': {'date': '2016-09-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional Ambulation Category(FAC)', 'timeFrame': '9 weeks from baseline'}], 'secondaryOutcomes': [{'measure': 'Motricity Index(MI)', 'timeFrame': '9 weeks from baseline'}, {'measure': '10 Meter Walk Test(10MWT)', 'timeFrame': '9 weeks from baseline'}, {'measure': '6 Minute Walk Test(6MWT)', 'timeFrame': '9 weeks from baseline'}, {'measure': 'Medical Research Council(MRC) Scale', 'timeFrame': '9 weeks from baseline'}, {'measure': 'Modified Ashworth Scale (MAS)', 'timeFrame': '9 weeks from baseline'}, {'measure': 'Fugl-Meyer Assessment(FMA) of Motor Recovery after Stroke', 'timeFrame': '9 weeks from baseline'}, {'measure': 'Modified Barthel Index(MBI)', 'timeFrame': '9 weeks from baseline'}, {'measure': 'National Institutes of Health Stroke Scale (NIHSS)', 'timeFrame': '9 weeks from baseline'}, {'measure': "Beck's Depression Inventory test (BDI)", 'timeFrame': '9 weeks from baseline'}, {'measure': 'Treatment Satisfaction Survey', 'timeFrame': '9 weeks from baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stroke'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'A clinical trial of robot-assisted-gait-training (RAGT) in stroke patients to evaluate its efficacy, safety over conventional gait training.', 'detailedDescription': 'Robot-assisted-gait-training (RAGT) in stroke patients to evaluate its efficacy, safety over conventional gait training.\n\nExperimental group receives robot-assisted-gait-training and conventional gait training.\n\nActive comparator group receives conventional gait training only as the same number as the experimental group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age more than 19 and under 80\n* Weight under 100kg\n* Height less than 200cm\n* Able to walk independently before onset of stroke\n* Ischemic or hemorrhagic stroke patients\n* Patients with motor paralysis and gait disturbance after stroke and seeking rehabilitation treatment\n* FAC(Functional Ambulation Category) under 3 (0\\~2)\n* Subacute stroke patients after 3 days and before 3 months of onset\n* Be informed of the nature of the study and agreed on written consent voluntarily\n* Patients taking medications or scheduled medications due to stroke\n\nExclusion Criteria:\n\n* Patients with contraindications to weight bearing such as fractures, etc.\n* Uncontrolled stage 2 hypertension (systolic over 160 mmHg or diastolic more than 100mmHg) or with uncontrolled orthostatic hypotension\n* Patients with cardiopulmonary disease or other underlying diseases that can not tolerate gait training\n* Patients with severe skin damage and bedsore on wearing part of the trial device\n* Pregnant or breast-feeding\n* Participation within 30 days of the other clinical trials\n* Patients whom the investigator considers inappropriate to participate in the study'}, 'identificationModule': {'nctId': 'NCT02694302', 'acronym': 'Walkbot', 'briefTitle': 'Clinical Trial of Robot-assisted-gait-training (RAGT) in Stroke Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'P&S Mechanics Co., Ltd.'}, 'officialTitle': 'A Multi-center, Parallel and Randomized Design Clinical Trial of Robot-assisted-gait-training (RAGT) in Stroke Patients to Evaluate Its Efficacy, Safety and Superiority Over Conventional Gait Training', 'orgStudyIdInfo': {'id': 'UMT2013-PS-WB-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Walkbot', 'description': 'Walkbot(robot assisted gait training) 30 minutes and conventional physical therapy 30 minutes each per day to be administered 5 times a week for 3 weeks.', 'interventionNames': ['Device: Walkbot', 'Device: Conventional physical therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional physical therapy', 'description': 'Conventional physical therapy 30 minutes to be administered twice a day, 5 times a week for 3 weeks.', 'interventionNames': ['Device: Conventional physical therapy']}], 'interventions': [{'name': 'Walkbot', 'type': 'DEVICE', 'description': 'Walkbot(robot assisted gait training) 30 minutes and conventional physical therapy 30 minutes each per day to be administered 5 times a week for 3 weeks.', 'armGroupLabels': ['Walkbot']}, {'name': 'Conventional physical therapy', 'type': 'DEVICE', 'description': 'Conventional physical therapy 30 minutes to be administered twice a day, 5 times a week for 3 weeks.', 'armGroupLabels': ['Conventional physical therapy', 'Walkbot']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01022', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'National Rehabilitation Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jung Hwan Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Rehabilitation Center, Korea'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'P&S Mechanics Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}