Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:22 AM
Study NCT ID:
NCT07333157
Status:
COMPLETED
Last Update Posted:
2026-01-12
First Post:
2025-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Wearable Passive Back Support Suit on Back Pain in Caregivers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001416', 'term': 'Back Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-30', 'studyFirstSubmitDate': '2025-12-30', 'studyFirstSubmitQcDate': '2025-12-30', 'lastUpdatePostDateStruct': {'date': '2026-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the Korean Oswestry Low Back Pain Disability Questionnaire(K-ODI) score', 'timeFrame': 'baseline, Week 2(after period 1), week 4(after washout) and week 6 (after period 2)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Back Pain', 'Exoskeleton Device']}, 'descriptionModule': {'briefSummary': 'The physical demands of patient transport, including lifting and transferring patients, are significant contributors to the high risk of musculoskeletal disorders. Previous studies have demonstrated that these workers frequently experience musculoskeletal pain. Although current prevention strategies primarily consist of passive education on posture, there is a clear need for more active, assistive methods. The emergence of wearable passive back support suits as a potential solution is noteworthy; however, robust clinical research on the effectiveness of these devices in real-world care giving environments is currently lacking.\n\nThe objective of this study is to investigate the effects of a wearable passive back support suit on reducing and preventing the incidence of back pain in patient transporters.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male adults aged 19 years or older\n2. Patient transport staff at Samsung Medical Center\n3. Able to wear a wearable passive back support suit\n\n * Height: 156cm-188cm\n * Chest circumference: 80cm-120cm\n * Thigh circumference: 36cm-62cm\n\nExclusion Criteria:\n\n1. Severe musculoskeletal disorders of the spine\n2. Severe musculoskeletal disorders of the lower extremities\n3. Contractures limiting the range of motion of the spine and lower extremities\n4. Fractures, open wounds, or unhealed ulcers on the spine or lower extremities\n5. Difficulty using a lumbar support device due to severe medical conditions, such as cardiovascular or pulmonary diseases\n6. History of osteoporotic fractures\n7. Neurological disorders affecting gait (e.g., stroke, Parkinson's disease, multiple sclerosis, etc.)\n8. Any other cases where the investigator determines that participation in this study is inappropriate"}, 'identificationModule': {'nctId': 'NCT07333157', 'acronym': 'back pain', 'briefTitle': 'Effects of Wearable Passive Back Support Suit on Back Pain in Caregivers', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Effects of Wearable Passive Back Support Suit on Back Pain in Caregivers', 'orgStudyIdInfo': {'id': '2025-01-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'wearable passive back support suit', 'interventionNames': ['Device: wearable passive back support suit']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'traditional lumbosacral orthosis', 'interventionNames': ['Device: traditional lumbosacral orthosis']}], 'interventions': [{'name': 'wearable passive back support suit', 'type': 'DEVICE', 'description': '2-week intervention periods using a wearable passive back support (Angel GEAR soft B10, Angel Robotics, Co., Ltd)', 'armGroupLabels': ['wearable passive back support suit']}, {'name': 'traditional lumbosacral orthosis', 'type': 'DEVICE', 'description': '2-week intervention periods using a traditional lumbosacral orthosis.', 'armGroupLabels': ['traditional lumbosacral orthosis']}]}, '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': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Won Hyuk Chang', 'investigatorAffiliation': 'Samsung Medical Center'}}}}