Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-01-04 @ 4:14 AM
Study NCT ID:
NCT03410550
Status:
COMPLETED
Last Update Posted:
2022-02-16
First Post:
2018-01-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exoskeleton and Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Twenty subjects will participate in a powered exoskeleton (EKSO) for one or twice a week for 12 weeks. The program will involve walking with the robotic suits for 1 hour for persons with complete (n=10) and persons with incomplete (n=10) SCI.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-01', 'studyFirstSubmitDate': '2018-01-11', 'studyFirstSubmitQcDate': '2018-01-18', 'lastUpdatePostDateStruct': {'date': '2022-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Pressure (mmHg)', 'timeFrame': '12 weeks', 'description': 'Resting blood pressure and post-exercise blood pressure will be measured every visit.'}, {'measure': 'Walking time (minutes)', 'timeFrame': '12 weeks', 'description': 'The robotic unit will measure standing up time, walking time and walking distance for every visit.'}, {'measure': 'Oxygen uptake (l/min)', 'timeFrame': '12 weeks', 'description': 'Oxygen uptake will be measured during sitting, standing and walking at the beginning and at the end of the training program.'}, {'measure': 'Body Composition (kg)', 'timeFrame': '12 weeks', 'description': "Body composition using dual energy x-ray absorptiometry anthropometrics' will be measured during sitting, standing and walking at the beginning and at the end of the training program."}], 'secondaryOutcomes': [{'measure': 'Six minute-walk Test (meter)', 'timeFrame': '12 weeks', 'description': 'The test will competed at the beginning and at the end of study to measure distance.'}, {'measure': 'Walking Index for Spinal Cord Injury II (WISCI II)', 'timeFrame': '12 weeks', 'description': 'The test will competed at the beginning and at the end of study'}, {'measure': 'Electromyography (EMG) activity of 6 muscle groups (mV)', 'timeFrame': '12 weeks', 'description': 'The test will competed at the beginning and at the end of study'}, {'measure': 'Mitochondrial health using near infra-red spectroscopy (seconds)', 'timeFrame': '12 weeks', 'description': 'The test will competed at the beginning and at the end of study'}, {'measure': '10 meter walk Test (m/sec)', 'timeFrame': '12 weeks', 'description': 'The test will competed at the beginning and at the end of study to measure speed.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Spinal Cord Injuries']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.frontiersin.org/articles/10.3389/fresc.2021.789422/full', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the current study is to investigate the effects of powered exoskeleton (EKSO) on cardiovascular performance as measured by resting blood pressure and heart rate, peak oxygen consumption during walking, energy expenditure, whole and regional body composition assessments. The effects of exoskeleton training on walking kinematics including stand-up time, walking time, distance covered and speed of walking will also be evaluated.', 'detailedDescription': 'Powered exoskeletons using robotic suits have recently been introduced for the rehabilitation of persons with spinal cord injury (SCI). Exoskeletons offer a unique opportunity for persons with SCI to experience standing and walking at a low metabolic cost. Evidence suggested that exoskeleton assisted walking can decrease spasticity and improve bowel movement. Training may also improve the level of physical activity as well as psychological parameters that are likely to interfere with rehabilitation outcomes. Previous studies reported that a frequency of 2-3 times per week or more for 1-2 hours may be beneficial in the rehabilitation of persons with SCI. Using exoskeletal-assisted walking to improve the level of physical activity may be appealing to persons with SCI.\n\nExoskeleton training for 12 weeks may enhance energy expenditure, parameters of physical activity and result only on modest effects on both cardiovascular and body composition parameters. In other words, persons with tetraplegia may have greater cardiovascular and body composition adaptations compared to persons with paraplegia. Twenty subjects will participate in a powered exoskeleton (EKSO) for one or twice a week for 12 weeks. The program will involve walking with the robotic suits for 1 hour for persons with complete (n=10) and persons with incomplete (n=10) SCI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. A written clearance by the medical doctor .\n2. Participants will have to be 1 year post-injury with any level of injury.\n3. All participants will be between 18-70 years old, men/women,\n\nExclusion Criteria:\n\n1. Participants with body weight greater than 220 lbs\n2. Whole body T-scores less than -2.5 standard deviation will result in elimination from the program.\n3. Hip width, upper leg length and lower leg length that do not fit in the robotic suit.\n4. Previous unhealed fracture in both lower or upper extremities\n5. Leg length discrepancy that is unlikely to be managed by having shoe inserts\n6. High resting blood pressure greater than 130/80 mmHg\n7. Sudden drop in blood pressure by 20 mmHg especially in persons with tetraplegia.\n8. Medical conditions prior enrollment similar to cardiovascular disease, uncontrolled type II diabetes mellitus, uncontrolled hypertension, and those on insulin, pressures sores stage 2 or greater, or urinary tract infection or symptoms.\n9. Pregnancy'}, 'identificationModule': {'nctId': 'NCT03410550', 'acronym': 'EXTra-SCI', 'briefTitle': 'Exoskeleton and Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'McGuire Research Institute'}, 'officialTitle': 'Exoskeleton Training After Spinal Cord Injury', 'orgStudyIdInfo': {'id': '02375'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exoskeleton Training', 'description': 'Twenty men with complete and incomplete SCI will be enrolled in the trial.', 'interventionNames': ['Device: Exoskeleton Training']}], 'interventions': [{'name': 'Exoskeleton Training', 'type': 'DEVICE', 'description': 'Twenty subjects will participate in a powered exoskeleton (EKSO) for one or twice a week for 12 weeks. The program will involve walking with the robotic suits for 1 hour for persons with complete (n=10) and persons with incomplete (n=10).', 'armGroupLabels': ['Exoskeleton Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23249', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Hunter Holmes McGuire VA Medical Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McGuire Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of SCI Research', 'investigatorFullName': 'Ashraf Gorgey', 'investigatorAffiliation': 'McGuire Research Institute'}}}}