Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-31 @ 2:36 PM
Study NCT ID:
NCT04285060
Status:
UNKNOWN
Last Update Posted:
2021-09-27
First Post:
2020-02-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Samsung GEMS-H Device Training in Sub-Acute and Chronic Stroke
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-24', 'studyFirstSubmitDate': '2020-02-24', 'studyFirstSubmitQcDate': '2020-02-24', 'lastUpdatePostDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of device malfunctions', 'timeFrame': 'Duration of study (estimated 12 months)', 'description': 'Device reliability will be assessed by the number of device malfunctions throughout the duration of the study'}, {'measure': 'ActiGraph activity monitor', 'timeFrame': 'Duration of study participation (estimated 4 months)', 'description': 'Changes in average daily step count'}, {'measure': 'Transcranial Magnetic Stimulation (TMS)', 'timeFrame': 'Baseline, Post-Intervention (estimated 8 weeks)', 'description': 'Measure changes in descending corticospinal drive to the lower limb muscles'}, {'measure': '10 Meter Walk Test (Self-selected walking speed) (10MWT-SS)', 'timeFrame': 'Baseline, Mid-Intervention (estimated 4 weeks), 1 month Post-Intervention (1 month follow-up)', 'description': 'Changes in self-selected walking speed measured without the device'}, {'measure': '10 Meter Walk Test (Fastest walking speed) (10MWT-FS)', 'timeFrame': 'Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)', 'description': 'Changes in fastest walking speed measured without the device'}, {'measure': '10 Meter Walk Test (Self-selected walking speed) (10MWT-SS) with the device', 'timeFrame': 'Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)', 'description': 'Changes in self-selected walking speeds between two conditions (with and without the device)'}, {'measure': '10 Meter Walk Test (Fastest walking speed) (10MWT-FS) with the device', 'timeFrame': 'Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)', 'description': 'Changes in fastest walking speeds between two conditions (with and without the device)'}, {'measure': '6 Minute Walk Test (6MWT)', 'timeFrame': 'Baseline, Mid-Intervention (estimated 4 weeks), 1 month Post-Intervention (1 month follow-up)', 'description': 'Changes in walking endurance measured without the device'}, {'measure': '6 Minute Walk Test (6MWT) with the device', 'timeFrame': 'Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)', 'description': 'Changes in walking endurance between two conditions (with and without the device)'}, {'measure': 'Berg Balance Scale (BBS)', 'timeFrame': 'Baseline, Mid-Intervention (estimated 4 weeks), 1 month Post-Intervention (1 month follow-up)', 'description': 'Changes in functional balance measured without the device'}, {'measure': 'Functional Gait Assessment (FGA)', 'timeFrame': 'Baseline, Mid-Intervention (estimated 4 weeks), 1 month Post-Intervention (1 month follow-up)', 'description': 'Change in functional balance measured without the device'}, {'measure': '5 Times Sit to Stand Test (5xSST)', 'timeFrame': 'Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)', 'description': 'Change in lower extremity strength measured without the device'}, {'measure': 'Gait analysis using a gait mat', 'timeFrame': 'Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)', 'description': 'Changes in spatiotemporal parameters measured without the device'}, {'measure': 'Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA)', 'timeFrame': 'Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)', 'description': 'Changes in motor recovery measured without the device'}, {'measure': 'Manual Muscle Testing (MMT)', 'timeFrame': 'Baseline, Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)', 'description': 'Changes in leg strength measured without the device'}, {'measure': 'Modified Ashworth Test (MAS)', 'timeFrame': 'Baseline, Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)', 'description': 'Changes in leg spasticity measured without the device'}, {'measure': 'Passive Range of Motion (PROM)', 'timeFrame': 'Baseline, Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)', 'description': 'Changes in passive range of motion in leg joints measured without the device'}, {'measure': 'Modified Falls Efficacy Scale (mFES)', 'timeFrame': 'Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)', 'description': 'Changes in perception of balance and stability'}, {'measure': 'Activities-specific and Balance Confidence Scale (ABC)', 'timeFrame': 'Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)', 'description': 'Changes in confidence in performing various ambulatory activities without falling'}, {'measure': 'Stoke Impact Scale (SIS)', 'timeFrame': 'Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)', 'description': 'Changes in the measure of the impact of stroke on overall physical and cognitive function'}, {'measure': 'Patient Health Questionnaire-9 (PHQ-9)', 'timeFrame': 'Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)', 'description': 'Changes in depression'}, {'measure': 'Stroke Specific Quality of Life (SSQoL)', 'timeFrame': 'Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)', 'description': 'Changes in the health-related quality of life'}, {'measure': 'Oxygen Consumption using Cosmed K4b2', 'timeFrame': 'Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)', 'description': 'Changes in metabolic energy expenditure'}], 'primaryOutcomes': [{'measure': 'Incidence of device related adverse events', 'timeFrame': 'Duration of study participation (estimated 6 months)', 'description': 'Safety will be assessed by the number of device related adverse events throughout the duration of the study'}, {'measure': '10 Meter Walk Test (Self-selected walking speed) (10MWT-SS)', 'timeFrame': 'Baseline, Post-Intervention (estimated 8 weeks)', 'description': 'Change in self-selected walking speed measured without the device'}], 'secondaryOutcomes': [{'measure': '6 Minute Walk Test (6MWT)', 'timeFrame': 'Baseline, Post-Intervention (estimated 8 weeks)', 'description': 'Change in walking endurance measured without the device'}, {'measure': 'Berg Balance Scale (BBS)', 'timeFrame': 'Baseline, Post-Intervention (estimated 8 weeks)', 'description': 'Changes in functional balance measured without the device'}, {'measure': 'Functional Gait Assessment (FGA)', 'timeFrame': 'Baseline, Post-Intervention (estimated 8 weeks)', 'description': 'Change in functional balance measured without the device'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Stroke', 'Exoskeleton'], 'conditions': ['Stroke', 'Chronic Stroke']}, 'referencesModule': {'references': [{'pmid': '39080666', 'type': 'DERIVED', 'citation': 'Macaluso R, Giffhorn M, Prokup S, Cleland B, Lee J, Lim B, Lee M, Lee HJ, Madhavan S, Jayaraman A. Safety & efficacy of a robotic hip exoskeleton on outpatient stroke rehabilitation. J Neuroeng Rehabil. 2024 Jul 30;21(1):127. doi: 10.1186/s12984-024-01421-x.'}]}, 'descriptionModule': {'briefSummary': 'A single-site, interventional, single-arm trial to evaluate the safety and efficacy on functional mobility following Samsung GEMS-H (Gait Enhancing and Motivating System - Hip) device training in participants with sub-acute and chronic stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ≥ 30-days post stroke\n* Age: 18-85 Years\n* Initial gait speed of ≥ 0.4 m/s and ≤ 0.8 m/s\n* Adequate cognitive function (MMSE score \\>17)\n* Ability to walk at least 10m with maximum 1 person assist\n* Physician approval for patient participation\n* Able to safely fit into device specifications and tolerate minimum assistance\n\nExclusion Criteria:\n\n* ≤90 days post major orthopedic surgery (i.e. hip, knee, and/or ankle joint replacement)\n* ≤ 6 months post coronary artery bypass graft (CABG) or cardiac valve procedure\n* Severe osteoporosis as indicated by physician medical clearance\n* Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living)\n* Pregnancy\n* Uncontrolled hypertension\n* Lower extremity fracture\n* Modified Ashworth Spasticity ≥3 in hip flexor or extensor\n* Preexisting neurological disorders such as Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), dementia\n* History of: major head trauma, lower extremity amputation, non-healing ulcers of a lower extremity, ongoing active infections, legal blindness, or a history of significant psychiatric illness\n* Participating in any other structured outpatient, home health physical therapy program, or another clinical trial that according to the Principal Investigator is likely to affect study outcome or confound results.\n\nTMS-Specific Exclusion Criteria\n\n* Pacemakers, metal implants in the head region\n* History of unexplained, recurring headaches, epilepsy/seizures/skull fractures or skull deficits\n* Medications that lower seizure threshold\n* History of concussion in last 6 months"}, 'identificationModule': {'nctId': 'NCT04285060', 'briefTitle': 'Safety and Efficacy of Samsung GEMS-H Device Training in Sub-Acute and Chronic Stroke', 'organization': {'class': 'INDUSTRY', 'fullName': 'Samsung Electronics'}, 'officialTitle': 'Safety and Efficacy on Functional Mobility Following Samsung GEMS-H Device Training in Sub-Acute and Chronic Stroke: A Pivotal Study', 'orgStudyIdInfo': {'id': '00210372'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Training Group', 'description': 'All participants are assigned to the training group with the Samsung GEMS-H.', 'interventionNames': ['Device: Samsung GEMS-H']}], 'interventions': [{'name': 'Samsung GEMS-H', 'type': 'DEVICE', 'description': 'Subjects will participate in 18 sessions of training in the outpatient clinic with a licensed physical therapist. Therapy sessions will include 30 minutes of task specific training and another 15 minutes of the session can be used to focus on patient specific goal areas related to functional mobility and balance. Training sessions will occur 2-3 times a week for 6-8 weeks to complete the training protocol.', 'armGroupLabels': ['Training Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Arun Jayaraman, Ph.D.', 'role': 'CONTACT', 'email': 'ajayaraman@sralab.org'}], 'facility': 'Shirley Ryan AbilityLab', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'centralContacts': [{'name': 'Arun Jayaraman, Ph.D.', 'role': 'CONTACT', 'email': 'ajayaraman@sralab.org', 'phone': '+1-312-238-6875'}, {'name': 'Kristen Hohl, DPT', 'role': 'CONTACT', 'email': 'khohl@sralab.org', 'phone': '+1-312-238-2640'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Electronics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Shirley Ryan AbilityLab', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}