Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:09 AM
Study NCT ID:
NCT07353203
Status:
RECRUITING
Last Update Posted:
2026-01-20
First Post:
2025-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Hip Assist Powered Exoskeleton for Gait Training in Patients With Late Subacute and Chronic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-15', 'studyFirstSubmitDate': '2025-12-05', 'studyFirstSubmitQcDate': '2026-01-15', 'lastUpdatePostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '10 Meter Walk Test', 'timeFrame': 'Baseline, after 5 intervention sessions(week 3) , and after 10 intervention sessions(Week 5)', 'description': '(lower limb motor score in 10 Meter Walk test at post-intervention) - (lower limb motor score in 10 Meter Walk Test at baseline) Higher scores mean a better outcome'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Stroke', 'Subacute Stroke', 'Exoskeleton']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the safety of gait training using a hip-assist powered exoskeleton. This will be assessed by collecting all device-related adverse events occurring during the entire intervention period, which consists of a total of 10 sessions within 5 weeks across two different gait rehabilitation protocols.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Adults aged 19 to 85 years.\n2. Patients with hemiplegia resulting from ischemic or hemorrhagic stroke.\n3. Patients in the late subacute or chronic phase, with stroke onset of 3 months or more (in cases of recurrent stroke, based on the most recent event). Functional Ambulation Category (FAC) score of 3 or higher.\n4. Patients capable of safely wearing the hip-assist powered exoskeleton and using it with minimal assistance.\n\n * Height: 140 cm - 190 cm\n * Weight: 80 kg or less\n5. Patients who were capable of independent walking and had no disability in daily self-care activities prior to stroke onset (based on the last stroke for recurrent patients). (mRS ≤2)\n6. Patients who have received approval for study participation from the attending medical staff.\n\nExclusion Criteria:\n\n1. Severe cognitive impairment (Mini-Mental State Examination \\[MMSE\\] \\< 10) or severe speech impairment/aphasia.\n2. History of major orthopedic surgery, such as hip, knee, or ankle arthroplasty, within the last 3 months.\n3. Fractures, open wounds, or unhealed ulcers in the lower extremities.\n4. Patients for whom gait training with the powered orthopedic device is difficult due to severe medical conditions, such as cardiovascular or pulmonary diseases.\n5. History of osteoporotic fractures.\n6. Patients with other neurological diseases affecting gait (e.g., Parkinson's disease, multiple sclerosis, etc.).\n7. Any other cases where the investigator deems participation in the study to be inappropriate."}, 'identificationModule': {'nctId': 'NCT07353203', 'acronym': 'brain disorder', 'briefTitle': 'Safety and Efficacy of Hip Assist Powered Exoskeleton for Gait Training in Patients With Late Subacute and Chronic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Safety and Efficacy of Hip Assist Powered Exoskeleton for Gait Training in Patients With Late Subacute and Chronic Stroke, Multi-center, Randomized Controlled Pilot Study', 'orgStudyIdInfo': {'id': '2025-08-147'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'gait assistance mode group', 'description': 'Gait training is performed in gait assistance mode while wearing a hip-assist powered exoskeleton', 'interventionNames': ['Device: gait assistance mode group']}, {'type': 'EXPERIMENTAL', 'label': 'Resistance mode', 'description': 'Gait training is performed in Resistance mode while wearing a hip-assist powered exoskeleton', 'interventionNames': ['Device: Resistance mode']}], 'interventions': [{'name': 'gait assistance mode group', 'type': 'DEVICE', 'description': 'A total of 10 sessions of gait training were performed using the hip-assist powered exoskeleton for 5 weeks (30 minutes per session)', 'armGroupLabels': ['gait assistance mode group']}, {'name': 'Resistance mode', 'type': 'DEVICE', 'description': 'A total of 10 sessions of gait training were performed using the hip-assist powered exoskeleton for 5 weeks (30 minutes per session)', 'armGroupLabels': ['Resistance mode']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Samsung Medical Center', 'role': 'CONTACT', 'email': 'wh.chang@samsung.com', 'phone': '82-2-3410-2832'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Won Hyuk Chang', 'role': 'CONTACT', 'email': 'wh.chang@samsung.com', 'phone': '+82-2-3410-6068'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Won Hyuk Chang', 'investigatorAffiliation': 'Samsung Medical Center'}}}}