Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT03767205
Status:
COMPLETED
Last Update Posted:
2019-12-09
First Post:
2018-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of a Ankle Assist Robot on Gait Function and Cardiopulmonary Metabolic Efficiency in Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D020233', 'term': 'Gait Disorders, Neurologic'}], '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'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-05', 'studyFirstSubmitDate': '2018-12-02', 'studyFirstSubmitQcDate': '2018-12-05', 'lastUpdatePostDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change on gait speed in different three conditions', 'timeFrame': '20minutes', 'description': 'All participants perform overground walking in different three conditions (with robot-torque on/with robot-torque off/without robot) to assess the change of gait speed using a motion analysis.'}], 'secondaryOutcomes': [{'measure': 'Change on gait function in different three conditions (kinematic)', 'timeFrame': '20minutes', 'description': 'All participants perform overground walking in different three conditions (with robot-torque on/with robot-torque off/without robot) to assess the change of kinematic using a motion analysis.'}, {'measure': 'Change on gait function in different three conditions (kinetic)', 'timeFrame': '20minutes', 'description': 'All participants perform overground walking in different three conditions (with robot-torque on/with robot-torque off/without robot) to assess the change of kinetic using a force plate.'}, {'measure': 'Change on gait function in different three conditions (muscle activation)', 'timeFrame': '20minutes', 'description': 'All participants perform overground walking in different three conditions (with robot-torque on/with robot-torque off/without robot) to assess the change of muscle activation using a surface EMG.'}, {'measure': 'Change on metabolic energy expenditure in different three conditions', 'timeFrame': '1 hour', 'description': 'All participants perform treadmill walking in different three conditions (with robot-torque on/with robot-torque off/without robot) to assess the change of metabolic energy expenditure using a portable cardiopulmonary metabolic system (Cosmed K4b², Rome, Italy).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gait function', 'Metabolic energy expenditure', 'ankle assist robot'], 'conditions': ['Stroke', 'Gait, Hemiplegic']}, 'referencesModule': {'references': [{'pmid': '40264191', 'type': 'DERIVED', 'citation': 'Lee SH, Kim J, Lee HJ, Kim YH. A wearable ankle-assisted robot for improving gait function and pattern in stroke patients. J Neuroeng Rehabil. 2025 Apr 22;22(1):89. doi: 10.1186/s12984-025-01624-w.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to identify the assistance effect of Ankle Assist Robot v1 developed by Samsung Advanced Institute of Technology (Samsung Electronics Co, Ltd., Korea) by comparing\n\n1. gait function during overground gait in three conditions (with robot-assist torque on/with robot-assist torque off/without robot)\n2. the energy expenditure during treadmill gait in three conditions (with robot-assist torque on/with robot-assist torque off/without robot)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stroke patients with hemiplegia over 19 years old\n* Ischemic or hemorrhagic stroke patients over 3 months of onset\n* Functional Ambulation Category Scale with 3 or more scales\n\nExclusion Criteria:\n\n* Stroke patients who have difficulty in walking independently regardless of assistive devices due to problems such as visual field defects or fractures\n* Stroke patients with walking difficulty due to serious cognitive problems\n* Patients with a foot size of 230 mm or less or a stroke of 280 mm or more that are not suitable for wearing ankle assist robot\n* Stroke patients at risk of falling when walking with severe dizziness\n* Modified ashworth scale (MAS) Stroke patients over 3\n* Pregnant woman\n* People with mental illness and psychiatric medication'}, 'identificationModule': {'nctId': 'NCT03767205', 'briefTitle': 'The Effect of a Ankle Assist Robot on Gait Function and Cardiopulmonary Metabolic Efficiency in Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'The Effect of a Ankle Assist Robot on Gait Function and Cardiopulmonary Metabolic Efficiency in Stroke Patients', 'orgStudyIdInfo': {'id': '2018-06-128'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'stroke patients', 'description': 'All participants perform overground walking and treadmill waking in three conditions (with robot-torque on/with robot-torque off/without robot).', 'interventionNames': ['Device: Ankle Assist Robot']}], 'interventions': [{'name': 'Ankle Assist Robot', 'type': 'DEVICE', 'description': '1. overground walking in three conditions (with robot-torque on/with robot-torque off/without robot). During overground walking, gait function was measured using motion analysis, sEMG, and force plate\n2. treadmill waking in three conditions (with robot-torque on/with robot-torque off/without robot). During treadmill walking, the metabolic energy expenditure was measured using a portable cardiopulmonary metabolic system (Cosmed K4b², Rome, Italy).', 'armGroupLabels': ['stroke patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'YunHee Kim, Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}