Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-03-06 @ 9:18 AM
Study NCT ID:
NCT05693233
Status:
UNKNOWN
Last Update Posted:
2023-01-20
First Post:
2022-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Soft Robotic Exosuit Assistance in Healthy People
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-12', 'studyFirstSubmitDate': '2022-12-23', 'studyFirstSubmitQcDate': '2023-01-12', 'lastUpdatePostDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'oxygen consumption measured', 'timeFrame': 'Simultaneous measurement of variables while walking on a treadmill_up to 24 weeks', 'description': '① Primary evaluation variable\n\n\\- The difference between the amount of oxygen consumption measured before wearing the robot and the amount of oxygen consumption measured before and after wearing the robot \\[O2 rate = VO2 (ml/min) / kg of body weight, O2 cost = rate / walking speed (m/ min)\\].'}], 'secondaryOutcomes': [{'measure': '3D Motion Capture', 'timeFrame': 'Simultaneous measurement of variables while walking on a treadmill_up to 24 weeks', 'description': '3D Motion Capture'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Person']}, 'descriptionModule': {'briefSummary': 'This study aims to find out what effect there is on the difference in energy use efficiency and gait analysis when walking while wearing knee and hip assist robots based on flexible power structures for normal people. Energy consumption efficiency will measure the amount of energy metabolism and heart rate during walking for a set period of time, and for gait analysis, kinetic and kinematic data will be analyzed through 3D motion analysis. In addition, after completing the evaluation, we intend to help in future improvement of the product by collecting usability and satisfaction evaluation and improvements through questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Healthy adults aged 19 years or older with no disabilities in walking in daily life and who have not had back or knee surgery in the past\n* Those who have no problem wearing knee and hip assist robots\n* A person who understands this research, has a willingness to participate voluntarily, and agrees to participate\n\nExclusion Criteria\n\n\\- researcher judges that participation in this research is inappropriate'}, 'identificationModule': {'nctId': 'NCT05693233', 'briefTitle': 'Effect of Soft Robotic Exosuit Assistance in Healthy People', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Effect of Soft Robotic Exosuit Assistance in Healthy People', 'orgStudyIdInfo': {'id': '4-2022-1220'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy person', 'description': 'Healthy person', 'interventionNames': ['Device: EXO On, EXO Off, EXO Removed treadmill (Uphill_incline 10°) walking and simultaneous evaluation']}], 'interventions': [{'name': 'EXO On, EXO Off, EXO Removed treadmill (Uphill_incline 10°) walking and simultaneous evaluation', 'type': 'DEVICE', 'description': '\\- After filling out the consent form for 10 subjects who meet the selection criteria, a total of three evaluations are conducted: one pre-evaluation and one post-evaluation for the knee assist robot and hip assist robot.\n\nPre-evaluation: Evaluation simultaneously with walking on an inclined treadmill (Uphill\\_incline 10°) for 5 minutes without wearing knee and hip assist robots (speed 1.5 m/s).', 'armGroupLabels': ['Healthy person']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Deog Young Kim', 'role': 'CONTACT', 'email': 'KIMDY@yuhs.ac', 'phone': '82-2-2228-3714'}], 'facility': 'Yonsei University Health System, Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Deog Young Kim', 'role': 'CONTACT', 'email': 'KIMDY@yuhs.ac', 'phone': '82-2-2228-3714'}], 'overallOfficials': [{'name': 'Deog Young Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Severance Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Available upon request', 'ipdSharing': 'YES', 'description': 'Available upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}