Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-04-18 @ 5:15 PM
Study NCT ID:
NCT02658656
Status:
COMPLETED
Last Update Posted:
2024-11-04
First Post:
2016-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Powered Exoskeletons in Persons With SCI
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ann.spungen@va.gov', 'phone': '7185849000', 'title': 'Dr. Ann Spungen, Study Chairperson', 'phoneExt': '5814', 'organization': 'James J Peters VA Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From consent to 4 month post intervention.', 'description': 'Events reported in the not randomized column were events that occurred prior to randomization. Events that occurred after randomization are reported under the respective treatment group.', 'eventGroups': [{'id': 'EG000', 'title': 'Exoskeleton + SOC', 'description': 'Patient will receive exoskeletal-assisted walking device for in home use for 4 months\n\nReWalk 6.0: Exoskeletal Assisted Walking Device', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 54, 'seriousNumAtRisk': 78, 'deathsNumAffected': 0, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'Standard of Care', 'description': 'Patient will receive standard of care (wheelchair use)', 'otherNumAtRisk': 83, 'deathsNumAtRisk': 83, 'otherNumAffected': 44, 'seriousNumAtRisk': 83, 'deathsNumAffected': 0, 'seriousNumAffected': 14}, {'id': 'EG002', 'title': 'Prior to Randomization', 'description': 'Consented patients prior to randomization', 'otherNumAtRisk': 424, 'deathsNumAtRisk': 424, 'otherNumAffected': 86, 'seriousNumAtRisk': 424, 'deathsNumAffected': 2, 'seriousNumAffected': 27}], 'otherEvents': [{'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Syringomyelia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anal incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Catheter site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Granuloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Medical device site bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Medical device site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Medical device site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Medical device site injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Medical device site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fungal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Medical device site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Prostate infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 15, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 23, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 18, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Autonomic dysreflexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Burns second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Buttock injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chemical burn of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 20, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 14, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 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'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Colonoscopy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anaplastic large-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle spasticity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Alcohol abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Drug use disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Self-injurious ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Decubitus ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Botulinum toxin injection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart valve operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 11, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Medical device implantation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Penile prosthesis insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 424, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Improvement on the MCS in All Randomized Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exoskeleton + SOC', 'description': 'Patient will receive exoskeletal-assisted walking device for in home use for 4 months\n\nReWalk 6.0: Exoskeletal Assisted Walking Device'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Patient will receive standard of care (wheelchair use)'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.798', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '.45', 'ciUpperLimit': '1.85', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Change from Baseline Assessment to 4 Months Post Intervention', 'description': 'Number of randomized participants with a greater than or equal to 4 point change on the Mental Health Component Summary (MCS) of the Veterans Rand-36 (VR-36) from Baseline Assessment to 4 Months Post Intervention. Possible range of the MCS is 0 to 100, with a higher score indicating higher mental wellbeing.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'PRIMARY', 'title': 'Improvement on the SCI-QOL Physical Medical Health Domain in All Randomized Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exoskeleton + SOC', 'description': 'Patient will receive exoskeletal-assisted walking device for in home use for 4 months\n\nReWalk 6.0: Exoskeletal Assisted Walking Device'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Patient will receive standard of care (wheelchair use)'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.935', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.44', 'ciUpperLimit': '2.15', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Change from Baseline Assessment to 4 Months Post Intervention', 'description': 'Number of randomized participants with a greater than or equal to 10 percent decrease on the SCI-QOL Physical Medical Health Domain (PMH) from Baseline Assessment to 4 Months Post Intervention. The PMH score is a sum of the SCI-QOL scores from the Bladder Management Difficulties, Bowel Management Difficulties, and Pain Interference item banks. Possible range of the PMH score is 110 to 253, with a lower score indicating better physical medical wellbeing.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Total Body Fat Loss in All Randomized Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exoskeleton + Standard of Care (SOC)', 'description': 'Patient will receive exoskeletal-assisted walking device for in home use for 4 months\n\nReWalk 6.0: Exoskeletal Assisted Walking Device'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'Patient will receive standard of care (wheelchair use)'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.829', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.49', 'ciUpperLimit': '1.79', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 months post intervention', 'description': 'Number of randomized participants with a greater than or equal to 1kg of total body fat loss from Baseline Assessment to 4 Months Post Intervention', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Improvement on the Mental Health Component Summary (MCS) in Participants Who Completed the 4 Month Intervention Phase.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exoskeleton + Standard of Care (SOC)', 'description': 'Patient will receive exoskeletal-assisted walking device for in home use for 4 months\n\nReWalk 6.0: Exoskeletal Assisted Walking Device'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'Patient will receive standard of care (wheelchair use)'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.809', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.56', 'ciUpperLimit': '2.11', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 months post intervention', 'description': 'Number of participants, out of those who completed the 4 month intervention phase, with a greater than or equal to 4 point increase on the Mental Health Component Summary (MCS) of the Veterans Rand-36 (VR-36) from Baseline Assessment to 4 Months Post Intervention. Possible range of the MCS is 0 to 100, with a higher score indicating higher mental wellbeing.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the 4 month intervention phase'}, {'type': 'SECONDARY', 'title': 'Improvement on the SCI-QOL Physical Medical Health Domain in Participants Who Completed the 4 Month Intervention Phase.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exoskeleton + Standard of Care (SOC)', 'description': 'Patient will receive exoskeletal-assisted walking device for in home use for 4 months\n\nReWalk 6.0: Exoskeletal Assisted Walking Device'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'Patient will receive standard of care (wheelchair use)'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.717', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.15', 'ciLowerLimit': '0.54', 'ciUpperLimit': '2.47', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 months post intervention', 'description': 'Number of participants, out of those who completed the 4 month intervention phase, with a greater than or equal to 10 percent improvement (decrease) on the Spinal Cord Injury Quality of Life (SCI-QOL) Physical Medical Health Domain (PMH) from Baseline Assessment to 4 Months Post Intervention. The PMH score is a sum of the SCI-QOL scores from the Bladder Management Difficulties, Bowel Management Difficulties, and Pain Interference item banks. Possible range of the PMH score is 110 to 253, with a lower score indicating better physical medical wellbeing.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants that completed the 4 month intervention phase'}, {'type': 'SECONDARY', 'title': 'Total Body Fat Loss in Participants Who Completed the 4 Month Intervention Phase.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exoskeleton + Standard of Care (SOC)', 'description': 'Patient will receive exoskeletal-assisted walking device for in home use for 4 months\n\nReWalk 6.0: Exoskeletal Assisted Walking Device'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'Patient will receive standard of care (wheelchair use)'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.738', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.11', 'ciLowerLimit': '0.61', 'ciUpperLimit': '2.02', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 months post intervention', 'description': 'Number of participants, out of those who completed the 4 month intervention phase, with a greater than or equal to 1kg of total body fat loss from Baseline Assessment to 4 Months Post Intervention', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'participants who completed the 4 month intervention phase'}, {'type': 'SECONDARY', 'title': 'Change in Mental Health Component Summary (MCS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exoskeleton + Standard of Care (SOC)', 'description': 'Patient will receive exoskeletal-assisted walking device for in home use for 4 months\n\nReWalk 6.0: Exoskeletal Assisted Walking Device'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'Patient will receive standard of care (wheelchair use)'}], 'classes': [{'title': 'Post training/orientation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '9.57', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '7.32', 'groupId': 'OG001'}]}]}, {'title': '2 month post intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '8.04', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '8.42', 'groupId': 'OG001'}]}]}, {'title': '4 month post intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '10.40', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '10.38', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post training/orientation, two months post intervention, and 4 months post intervention.', 'description': 'Mean difference score in the Mental Health Component Summary (MCS) of the Veterans Rand-36 (VR-36) from baseline to post training/orientation, two months post intervention, and 4 months post intervention. Possible range of the MCS is 0 to 100, with a higher score indicating higher mental wellbeing.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants with a Mental Health Component Summary (MCS) score at baseline and at least one of the following time points: post training/orientation, two months post intervention, or 4 months post intervention.'}, {'type': 'SECONDARY', 'title': 'Change in SCI-QOL Physical Medical Health Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exoskeleton + Standard of Care (SOC)', 'description': 'Patient will receive exoskeletal-assisted walking device for in home use for 4 months\n\nReWalk 6.0: Exoskeletal Assisted Walking Device'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'Patient will receive standard of care (wheelchair use)'}], 'classes': [{'title': 'Post training/orientation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.4', 'spread': '17.60', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '16.59', 'groupId': 'OG001'}]}]}, {'title': '2 month post intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.9', 'spread': '15.56', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '17.73', 'groupId': 'OG001'}]}]}, {'title': '4 month post intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.9', 'spread': '17.71', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '19.99', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post training/orientation, two months post intervention, and 4 months post intervention.', 'description': 'Mean difference score in the SCI-QOL Physical Medical Health Domain from baseline to post training/orientation, two months post intervention, and 4 months post intervention. The PMH score is a sum of the SCI-QOL scores from the Bladder Management Difficulties, Bowel Management Difficulties, and Pain Interference item banks. Possible range of the PMH score is 110 to 253, with a lower score indicating better physical medical wellbeing.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants with a PMH score at baseline and at least one of the following time points: post training/orientation, two months post intervention, or 4 months post intervention.'}, {'type': 'SECONDARY', 'title': 'Change in Total Body Fat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exoskeleton + Standard of Care (SOC)', 'description': 'Patient will receive exoskeletal-assisted walking device for in home use for 4 months\n\nReWalk 6.0: Exoskeletal Assisted Walking Device'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'Patient will receive standard of care (wheelchair use)'}], 'classes': [{'title': 'Post training/orientation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '2.01', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.82', 'groupId': 'OG001'}]}]}, {'title': '2 month post intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '3.13', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '2.84', 'groupId': 'OG001'}]}]}, {'title': '4 month post intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '3.75', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '3.59', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post training/orientation, two months post intervention, and 4 months post intervention.', 'description': 'Change in total body fat from baseline to post training/orientation, two months post intervention, and 4 months post intervention', 'unitOfMeasure': 'kilograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants with a total body fat measurement at baseline and at least one of the following time points: post training/orientation, two months post intervention, or 4 months post intervention.'}, {'type': 'SECONDARY', 'title': 'Change in SCI-QOL Social Participation Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exoskeleton + Standard of Care (SOC)', 'description': 'Patient will receive exoskeletal-assisted walking device for in home use for 4 months\n\nReWalk 6.0: Exoskeletal Assisted Walking Device'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'Patient will receive standard of care (wheelchair use)'}], 'classes': [{'title': 'post training/orientation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '14.74', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '13.58', 'groupId': 'OG001'}]}]}, {'title': '2 month post intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '17.13', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '13.45', 'groupId': 'OG001'}]}]}, {'title': '4 month post intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.1', 'spread': '15.00', 'groupId': 'OG000'}, {'value': '-3.0', 'spread': '16.59', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post training/orientation, two months post intervention, and 4 months post intervention.', 'description': 'Mean difference score in the SCI-QOL Social Health Domain from baseline to post training/orientation, two months post intervention, and 4 months post intervention. The Social Health Domain score is a sum of the SCI-QOL scores from the ability to participate in social roles and activities, satisfaction with social roles and activities, and independence item banks. Possible range of the Social Health Domain score is 78 to 191, with a higher score indicating higher social health.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants with a Social Health Domain score at baseline and at least one of the following time points: post training/orientation, two months post intervention, or 4 months post intervention.'}, {'type': 'SECONDARY', 'title': 'Change in SCI-QOL Positive Emotional Constraints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exoskeleton + Standard of Care (SOC)', 'description': 'Patient will receive exoskeletal-assisted walking device for in home use for 4 months\n\nReWalk 6.0: Exoskeletal Assisted Walking Device'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'Patient will receive standard of care (wheelchair use)'}], 'classes': [{'title': 'Post Training/Orientation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '17.72', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '16.87', 'groupId': 'OG001'}]}]}, {'title': '2 months post intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '16.28', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '16.71', 'groupId': 'OG001'}]}]}, {'title': '4 months post intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.6', 'spread': '14.99', 'groupId': 'OG000'}, {'value': '-3.2', 'spread': '20.63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post training/orientation, two months post intervention, and 4 months post intervention.', 'description': 'Mean difference score in the SCI-QOL Positive Emotional Constraints from baseline to post training/orientation, two months post intervention, and 4 months post intervention. The Positive Emotional Constraints score is a sum of the SCI-QOL scores from the positive affect and well being, self-esteem, and resilience item banks. Possible range of the Positive Emotional Constraints score is 63 to 199, with a higher score indicating better emotional wellbeing.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants with a score on the SCI-QOL Positive Emotional Constraints at baseline and at least one of the following time points: post training/orientation, two months post intervention, or 4 months post intervention.'}, {'type': 'SECONDARY', 'title': 'Change in SCI-QOL Negative Emotional Constraints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exoskeleton + Standard of Care (SOC)', 'description': 'Patient will receive exoskeletal-assisted walking device for in home use for 4 months\n\nReWalk 6.0: Exoskeletal Assisted Walking Device'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'Patient will receive standard of care (wheelchair use)'}], 'classes': [{'title': 'post training/orientation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.5', 'spread': '25.20', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '22.42', 'groupId': 'OG001'}]}]}, {'title': '2 months post intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.4', 'spread': '21.83', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '22.05', 'groupId': 'OG001'}]}]}, {'title': '4 months post intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.6', 'spread': '22.34', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '26.91', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post training/orientation, two months post intervention, and 4 months post intervention.', 'description': 'Mean difference score in the SCI-QOL Negative Emotional Constraints from baseline to post training/orientation, two months post intervention, and 4 months post intervention. The Negative Emotional Constraints score is a sum of the SCI-QOL scores from the anxiety, depression, grief-loss, trauma, and stigma item banks. Possible range of the Negative Emotional Constraints score is 182 to 405, with a lower score indicating better emotional wellbeing.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants with a score on SCI-QOL Negative Emotional Constraints at baseline and at least one of the following time points: post training/orientation, two months post intervention, or 4 months post intervention.'}, {'type': 'SECONDARY', 'title': 'Change in SCI Functional Index (FI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exoskeleton + Standard of Care (SOC)', 'description': 'Patient will receive exoskeletal-assisted walking device for in home use for 4 months\n\nReWalk 6.0: Exoskeletal Assisted Walking Device'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'Patient will receive standard of care (wheelchair use)'}], 'classes': [{'title': 'Post Training/Orientation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.4', 'spread': '20.97', 'groupId': 'OG000'}, {'value': '-5.8', 'spread': '11.63', 'groupId': 'OG001'}]}]}, {'title': 'Two months post intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.3', 'spread': '16.00', 'groupId': 'OG000'}, {'value': '-4.5', 'spread': '12.99', 'groupId': 'OG001'}]}]}, {'title': '4 months post intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.8', 'spread': '16.36', 'groupId': 'OG000'}, {'value': '-8.6', 'spread': '20.60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post training/orientation, two months post intervention, and 4 months post intervention.', 'description': 'Mean difference score in the SCI Functional Index (FI) from baseline to post training/orientation, two months post intervention, and 4 months post intervention. The SCI Function Index for physical function is a sum of the basic mobility, ambulation, fine motor, self-care, and wheelchair mobility item banks. Possible range of the SCI Functional Index is 188 to 408, with a higher score indicating better physical function.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants with a score on the SCI FI at baseline and at least one of the following time points: post training/orientation, two months post intervention, or 4 months post intervention.'}, {'type': 'SECONDARY', 'title': 'Change in Sleep Disturbance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exoskeleton + Standard of Care (SOC)', 'description': 'Patient will receive exoskeletal-assisted walking device for in home use for 4 months\n\nReWalk 6.0: Exoskeletal Assisted Walking Device'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'Patient will receive standard of care (wheelchair use)'}], 'classes': [{'title': 'Post Training/Orientation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '8.83', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '7.57', 'groupId': 'OG001'}]}]}, {'title': '2 months post intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '8.75', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '7.50', 'groupId': 'OG001'}]}]}, {'title': '4 months post intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '9.91', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '7.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post training/orientation, two months post intervention, and 4 months post intervention.', 'description': 'Mean difference T-score of the Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance from baseline to post training/orientation, two months post intervention, and 4 months post intervention. Possible range of the PROMIS is 28.9 to 76.5, with a higher score indicating more sleep disturbance.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized with a score on the PROMIS Sleep Disturbance score at baseline and at least one of the following time points: post training/orientation, two months post intervention, or 4 months post intervention.'}, {'type': 'SECONDARY', 'title': 'Change in Participant Impression of Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exoskeleton + Standard of Care (SOC)', 'description': 'Patient will receive exoskeletal-assisted walking device for in home use for 4 months\n\nReWalk 6.0: Exoskeletal Assisted Walking Device'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'Patient will receive standard of care (wheelchair use)'}], 'classes': [{'title': 'Post Training/Orientation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '1.06', 'groupId': 'OG001'}]}]}, {'title': '2 months post intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.13', 'groupId': 'OG001'}]}]}, {'title': '4 months post intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.17', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post training/orientation, two months post intervention, and 4 months post intervention.', 'description': 'Mean difference in the participant impression of severity of spinal cord injury from the Global Impression of Change Scale from baseline to post training/orientation, two months post intervention, and 4 months post intervention. Possible range of the participant impression of severity is 1 to 7, with a higher score indicating worse impression of severity of spinal cord injury.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants with an impression of severity score on the Global Impression of Change Scale at baseline and at least one of the following time points: post training/orientation, two months post intervention, or 4 months post intervention.'}, {'type': 'SECONDARY', 'title': 'Change in Companion Impression of Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exoskeleton + Standard of Care (SOC)', 'description': 'Patient will receive exoskeletal-assisted walking device for in home use for 4 months\n\nReWalk 6.0: Exoskeletal Assisted Walking Device'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'Patient will receive standard of care (wheelchair use)'}], 'classes': [{'title': 'Post Training/Orientation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '1.13', 'groupId': 'OG001'}]}]}, {'title': 'Two months post intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '1.55', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.48', 'groupId': 'OG001'}]}]}, {'title': '4 months post intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post training/orientation, two months post intervention, and 4 months post intervention.', 'description': 'Mean difference in the companion impression of severity of spinal cord injury from the Global Impression of Change Scale from baseline to post training/orientation, two months post intervention, and 4 months post intervention. Possible range of the companion impression of severity is 1 to 7, with a higher score indicating worse impression of severity of spinal cord injury.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants with a companion impression of severity score on the Global Impression of Change Scale at baseline and at least one of the following time points: post training/orientation, two months post intervention, or 4 months post intervention.'}, {'type': 'SECONDARY', 'title': 'Bowel Evacuation Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exoskeleton + Standard of Care (SOC)', 'description': 'Patient will receive exoskeletal-assisted walking device for in home use for 4 months\n\nReWalk 6.0: Exoskeletal Assisted Walking Device'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'Patient will receive standard of care (wheelchair use)'}], 'classes': [{'categories': [{'title': '5 to 15 minutes', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': '15 to 30 minutes', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'title': '30 to 60 minutes', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}, {'title': '1 to 3 hours', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'More than 3 hours', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 months post intervention', 'description': 'Time spent to have a bowel movement per bowel day, over 7 days. Responses were collected using a 5-point likert scale with the following options: 5 to 15 minutes; 15 to 30 minutes; 30 to 60 minutes; 1 to 3 hours; more than 3 hours.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Frequency of Bowel Evacuation Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exoskeleton + Standard of Care (SOC)', 'description': 'Patient will receive exoskeletal-assisted walking device for in home use for 4 months\n\nReWalk 6.0: Exoskeletal Assisted Walking Device'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'Patient will receive standard of care (wheelchair use)'}], 'classes': [{'categories': [{'title': '7 times or more', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}, {'title': '5-6 times', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': '3-4 times', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}, {'title': '1-2 times', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'None', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 months post intervention', 'description': 'Frequency of bowel movements over 7 days. Responses were collected using a 5-point Likert scale with the following options: 7 times or more; 5 to 6 times; 3 to 4 times; 1 to 2 times; none.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Manual/Digit Stimulation for Bowel Movements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exoskeleton + Standard of Care (SOC)', 'description': 'Patient will receive exoskeletal-assisted walking device for in home use for 4 months\n\nReWalk 6.0: Exoskeletal Assisted Walking Device'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'Patient will receive standard of care (wheelchair use)'}], 'classes': [{'categories': [{'title': 'None/never', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'Only once', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'A few times', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Most times', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Every time', 'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 months post intervention', 'description': 'Needed manual/digit stimulation for bowel movements over 7 days. Responses were collected using a 5-point Likert scale with the following options: none/never; only once; a few times; most times; every time.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Oral Medications for Bowel Movements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exoskeleton + Standard of Care (SOC)', 'description': 'Patient will receive exoskeletal-assisted walking device for in home use for 4 months\n\nReWalk 6.0: Exoskeletal Assisted Walking Device'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'Patient will receive standard of care (wheelchair use)'}], 'classes': [{'categories': [{'title': 'None/never', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}, {'title': 'Only once', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'A few times', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Most times', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Every time', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 months post intervention', 'description': 'Required oral medications to help with bowel movements over 7 days. Responses were collected using a 5-point Likert scale with the following options: none/never; only once; a few times; most times; every time.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Enemas or Irrigations for Bowel Movements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exoskeleton + Standard of Care (SOC)', 'description': 'Patient will receive exoskeletal-assisted walking device for in home use for 4 months\n\nReWalk 6.0: Exoskeletal Assisted Walking Device'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'Patient will receive standard of care (wheelchair use)'}], 'classes': [{'categories': [{'title': 'None/never', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}, {'title': 'Only once', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'A few times', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Most times', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Every time', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 months post intervention', 'description': 'Required enemas or irrigations to help with bowel movements over 7 days. Responses were collected using a 5-point Likert scale with the following options: none/never; only once; a few times; most times; every time.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bowel Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exoskeleton + Standard of Care (SOC)', 'description': 'Patient will receive exoskeletal-assisted walking device for in home use for 4 months\n\nReWalk 6.0: Exoskeletal Assisted Walking Device'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'Patient will receive standard of care (wheelchair use)'}], 'classes': [{'categories': [{'title': 'No leakage or accidents', 'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}, {'title': 'Leakage or an accident 1-2 times', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'Leakage or an accident 3-4 times', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Leakage or an accident 5-6 times', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Leakage or an accident 7 or more times', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 months post intervention', 'description': 'Bowel accidents over 7 days. Responses were collected using a 5-point Likert scale with the following options: no leakage or accidents; leakage or an accident 1-2 times; leakage or an accident 3-4 times; leakage or an accident 5-6 times; leakage or an accident 7 or more times.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Stool Consistency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exoskeleton + Standard of Care (SOC)', 'description': 'Patient will receive exoskeletal-assisted walking device for in home use for 4 months\n\nReWalk 6.0: Exoskeletal Assisted Walking Device'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'Patient will receive standard of care (wheelchair use)'}], 'classes': [{'categories': [{'title': 'Separate hard lumps', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Sausage-shaped, but lumpy', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Like sausage, cracks on surface', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'title': 'Like a snake, smooth and soft', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'title': 'Soft blobs (passed easily)', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Fluffy pieces, a mush stool', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Watery, entirely liquid', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 months post intervention', 'description': 'Stool consistency by the Bristol Stool Scale over 7 days. The Bristol Stool Scale classifies stools into seven groups: separate hard lumps; sausage-shaped, but lumpy; like sausage, cracks on surface; like a snake, smooth and soft; soft blobs (passed easily); fluffy pieces, a mush stool; watery, entirely liquid.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Abdominal Fat Mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exoskeleton + Standard of Care (SOC)', 'description': 'Patient will receive exoskeletal-assisted walking device for in home use for 4 months\n\nReWalk 6.0: Exoskeletal Assisted Walking Device'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'Patient will receive standard of care (wheelchair use)'}], 'classes': [{'title': 'Post Training/Orientation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57', 'spread': '269.4', 'groupId': 'OG000'}, {'value': '30', 'spread': '247.8', 'groupId': 'OG001'}]}]}, {'title': 'Two months post intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '93', 'spread': '351.6', 'groupId': 'OG000'}, {'value': '2', 'spread': '247.4', 'groupId': 'OG001'}]}]}, {'title': '4 months post intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67', 'spread': '360.2', 'groupId': 'OG000'}, {'value': '21', 'spread': '273.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post training/orientation, two months post intervention, and 4 months post intervention.', 'description': 'Change in visceral adipose tissue mass measured from bone density scan, in grams, from baseline to post training/orientation, two months post intervention, and 4 months post intervention', 'unitOfMeasure': 'grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants with a bone density scan at baseline and at least one of the following time points: post training/orientation, two months post intervention, or 4 months post intervention.'}, {'type': 'SECONDARY', 'title': 'Change in High Density Lipoprotein Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exoskeleton + Standard of Care (SOC)', 'description': 'Patient will receive exoskeletal-assisted walking device for in home use for 4 months\n\nReWalk 6.0: Exoskeletal Assisted Walking Device'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'Patient will receive standard of care (wheelchair use)'}], 'classes': [{'title': 'Post Training/Orientation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '6.55', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '8.66', 'groupId': 'OG001'}]}]}, {'title': 'Two Months post intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '6.42', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '8.11', 'groupId': 'OG001'}]}]}, {'title': '4 months post intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '7.3', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '7.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post training/orientation, two months post intervention, and 4 months post intervention.', 'description': 'Change in high density lipoprotein cholesterol, in milligrams per deciliter (mg/dL), from baseline to post training/orientation, two months post intervention, and 4 months post intervention', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants with a high density lipoprotein cholesterol lab value at baseline and at least one of the following time points: post training/orientation, two months post intervention, or 4 months post intervention.'}, {'type': 'SECONDARY', 'title': 'Change in Low Density Lipoprotein Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exoskeleton + Standard of Care (SOC)', 'description': 'Patient will receive exoskeletal-assisted walking device for in home use for 4 months\n\nReWalk 6.0: Exoskeletal Assisted Walking Device'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'Patient will receive standard of care (wheelchair use)'}], 'classes': [{'title': 'Post training/Orientation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '24.26', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '28.49', 'groupId': 'OG001'}]}]}, {'title': 'Two months post intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '21.15', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '21.13', 'groupId': 'OG001'}]}]}, {'title': '4 months post intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '20.77', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '23.97', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post training/orientation, two months post intervention, and 4 months post intervention.', 'description': 'Change in low density lipoprotein cholesterol, in milligrams per deciliter (mg/dL), from baseline to post training/orientation, two months post intervention, and 4 months post intervention', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants with a low density lipoprotein cholesterol lab value at baseline and at least one of the following time points: post training/orientation, two months post intervention, or 4 months post intervention.'}, {'type': 'SECONDARY', 'title': 'Change in Total Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exoskeleton + Standard of Care (SOC)', 'description': 'Patient will receive exoskeletal-assisted walking device for in home use for 4 months\n\nReWalk 6.0: Exoskeletal Assisted Walking Device'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'Patient will receive standard of care (wheelchair use)'}], 'classes': [{'title': 'Post Training/Orientation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': '32.44', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '31.42', 'groupId': 'OG001'}]}]}, {'title': 'Two months post intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.6', 'spread': '31.93', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '26.08', 'groupId': 'OG001'}]}]}, {'title': '4 Months post intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.8', 'spread': '36.71', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '29.65', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post training/orientation, two months post intervention, and 4 months post intervention.', 'description': 'Change in total cholesterol, in milligrams per deciliter (mg/dL), from baseline to post training/orientation, two months post intervention, and 4 months post intervention', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants with a total cholesterol lab value at baseline and at least one of the following time points: post training/orientation, two months post intervention, or 4 months post intervention.'}, {'type': 'SECONDARY', 'title': 'Change in Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exoskeleton + Standard of Care (SOC)', 'description': 'Patient will receive exoskeletal-assisted walking device for in home use for 4 months\n\nReWalk 6.0: Exoskeletal Assisted Walking Device'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'Patient will receive standard of care (wheelchair use)'}], 'classes': [{'title': 'Post Training/Orientation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.9', 'spread': '61.78', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '57.37', 'groupId': 'OG001'}]}]}, {'title': 'Two months post intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '68.36', 'groupId': 'OG000'}, {'value': '9.5', 'spread': '68.17', 'groupId': 'OG001'}]}]}, {'title': '4 months post intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.9', 'spread': '104.2', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '61.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post training/orientation, two months post intervention, and 4 months post intervention.', 'description': 'Change in triglycerides, in milligrams per deciliter (mg/dL), from baseline to post training/orientation, two months post intervention, and 4 months post intervention', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants with a triglycerides lab value at baseline and at least one of the following time points: post training/orientation, two months post intervention, or 4 months post intervention.'}, {'type': 'SECONDARY', 'title': 'Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exoskeleton + Standard of Care (SOC)', 'description': 'Patient will receive exoskeletal-assisted walking device for in home use for 4 months\n\nReWalk 6.0: Exoskeletal Assisted Walking Device'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'Patient will receive standard of care (wheelchair use)'}], 'classes': [{'title': 'Post Training/Orientation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '3.94', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '2.68', 'groupId': 'OG001'}]}]}, {'title': 'Two months post intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '11.4', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '4.27', 'groupId': 'OG001'}]}]}, {'title': '4 months post intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '8.11', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '3.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post training/orientation, two months post intervention, and 4 months post intervention.', 'description': 'Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), from baseline to post training/orientation, two months post intervention, and 4 months post intervention. HOMA-IR= Fasting insulin (mIU/ml) x Fasting glucose (mg/dl) / 405.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants with fasting insulin and fasting glucose lab values at baseline and at least one of the following time points: post training/orientation, two months post intervention, or 4 months post intervention.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Exoskeleton + Standard of Care (SOC)', 'description': 'Patient will receive exoskeletal-assisted walking device for in home use for 4 months\n\nReWalk 6.0: Exoskeletal Assisted Walking Device'}, {'id': 'FG001', 'title': 'Standard of Care', 'description': 'Patient will receive standard of care (wheelchair use)'}, {'id': 'FG002', 'title': 'Screen Failures', 'description': 'Consented participants who failed screening and were not randomized.'}], 'periods': [{'title': 'Screening', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '83'}, {'groupId': 'FG002', 'numSubjects': '263'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '83'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '263'}]}], 'dropWithdraws': [{'type': 'Failed eligibility criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '263'}]}]}, {'title': 'Randomization', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '83'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '57'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Administrative Termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Administrative Termination due to COVID-19 Restrictions', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Failed Exoskeletal-assisted walking (EAW) Advanced Skills Test', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Not eligible for Randomization', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Exoskeleton + SOC', 'description': 'Patient will receive exoskeletal-assisted walking device for in home use for 4 months\n\nReWalk 6.0: Exoskeletal Assisted Walking Device'}, {'id': 'BG001', 'title': 'Standard of Care', 'description': 'Patient will receive standard of care (wheelchair use)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.3', 'spread': '13.61', 'groupId': 'BG000'}, {'value': '46.2', 'spread': '13.27', 'groupId': 'BG001'}, {'value': '46.2', 'spread': '13.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Mental Health Component Summary (MCS) of the Veterans Rand-36 (VR-36)', 'classes': [{'categories': [{'measurements': [{'value': '60.6', 'spread': '10.85', 'groupId': 'BG000'}, {'value': '59.2', 'spread': '11.71', 'groupId': 'BG001'}, {'value': '59.9', 'spread': '11.29', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Mental Health Component Summary (MCS) of the VR-36 measures the vitality, social functioning, role-emotional, and mental health of the participant. Possible range of the MCS is 0 to 100, with a higher score indicating higher mental wellbeing.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'SCI-QOL Physical Medical Health Domain', 'classes': [{'categories': [{'measurements': [{'value': '153', 'spread': '21.11', 'groupId': 'BG000'}, {'value': '153', 'spread': '23.93', 'groupId': 'BG001'}, {'value': '153', 'spread': '22.54', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The sum T-score for the SCI-QOL Physical Medical Health domain (three item banks of Bladder Management Difficulties, Bowel Management Difficulties, and Pain Interference). Possible score range is 110 to 253, with a lower score indicating better physical medical wellbeing.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-12', 'size': 1640532, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-03-22T11:28', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 424}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-23', 'studyFirstSubmitDate': '2016-01-06', 'resultsFirstSubmitDate': '2022-03-30', 'studyFirstSubmitQcDate': '2016-01-14', 'lastUpdatePostDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-05-10', 'studyFirstPostDateStruct': {'date': '2016-01-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement on the MCS in All Randomized Participants', 'timeFrame': 'Change from Baseline Assessment to 4 Months Post Intervention', 'description': 'Number of randomized participants with a greater than or equal to 4 point change on the Mental Health Component Summary (MCS) of the Veterans Rand-36 (VR-36) from Baseline Assessment to 4 Months Post Intervention. Possible range of the MCS is 0 to 100, with a higher score indicating higher mental wellbeing.'}, {'measure': 'Improvement on the SCI-QOL Physical Medical Health Domain in All Randomized Participants', 'timeFrame': 'Change from Baseline Assessment to 4 Months Post Intervention', 'description': 'Number of randomized participants with a greater than or equal to 10 percent decrease on the SCI-QOL Physical Medical Health Domain (PMH) from Baseline Assessment to 4 Months Post Intervention. The PMH score is a sum of the SCI-QOL scores from the Bladder Management Difficulties, Bowel Management Difficulties, and Pain Interference item banks. Possible range of the PMH score is 110 to 253, with a lower score indicating better physical medical wellbeing.'}], 'secondaryOutcomes': [{'measure': 'Total Body Fat Loss in All Randomized Participants', 'timeFrame': '4 months post intervention', 'description': 'Number of randomized participants with a greater than or equal to 1kg of total body fat loss from Baseline Assessment to 4 Months Post Intervention'}, {'measure': 'Improvement on the Mental Health Component Summary (MCS) in Participants Who Completed the 4 Month Intervention Phase.', 'timeFrame': '4 months post intervention', 'description': 'Number of participants, out of those who completed the 4 month intervention phase, with a greater than or equal to 4 point increase on the Mental Health Component Summary (MCS) of the Veterans Rand-36 (VR-36) from Baseline Assessment to 4 Months Post Intervention. Possible range of the MCS is 0 to 100, with a higher score indicating higher mental wellbeing.'}, {'measure': 'Improvement on the SCI-QOL Physical Medical Health Domain in Participants Who Completed the 4 Month Intervention Phase.', 'timeFrame': '4 months post intervention', 'description': 'Number of participants, out of those who completed the 4 month intervention phase, with a greater than or equal to 10 percent improvement (decrease) on the Spinal Cord Injury Quality of Life (SCI-QOL) Physical Medical Health Domain (PMH) from Baseline Assessment to 4 Months Post Intervention. The PMH score is a sum of the SCI-QOL scores from the Bladder Management Difficulties, Bowel Management Difficulties, and Pain Interference item banks. Possible range of the PMH score is 110 to 253, with a lower score indicating better physical medical wellbeing.'}, {'measure': 'Total Body Fat Loss in Participants Who Completed the 4 Month Intervention Phase.', 'timeFrame': '4 months post intervention', 'description': 'Number of participants, out of those who completed the 4 month intervention phase, with a greater than or equal to 1kg of total body fat loss from Baseline Assessment to 4 Months Post Intervention'}, {'measure': 'Change in Mental Health Component Summary (MCS)', 'timeFrame': 'post training/orientation, two months post intervention, and 4 months post intervention.', 'description': 'Mean difference score in the Mental Health Component Summary (MCS) of the Veterans Rand-36 (VR-36) from baseline to post training/orientation, two months post intervention, and 4 months post intervention. Possible range of the MCS is 0 to 100, with a higher score indicating higher mental wellbeing.'}, {'measure': 'Change in SCI-QOL Physical Medical Health Domain', 'timeFrame': 'post training/orientation, two months post intervention, and 4 months post intervention.', 'description': 'Mean difference score in the SCI-QOL Physical Medical Health Domain from baseline to post training/orientation, two months post intervention, and 4 months post intervention. The PMH score is a sum of the SCI-QOL scores from the Bladder Management Difficulties, Bowel Management Difficulties, and Pain Interference item banks. Possible range of the PMH score is 110 to 253, with a lower score indicating better physical medical wellbeing.'}, {'measure': 'Change in Total Body Fat', 'timeFrame': 'post training/orientation, two months post intervention, and 4 months post intervention.', 'description': 'Change in total body fat from baseline to post training/orientation, two months post intervention, and 4 months post intervention'}, {'measure': 'Change in SCI-QOL Social Participation Domain', 'timeFrame': 'post training/orientation, two months post intervention, and 4 months post intervention.', 'description': 'Mean difference score in the SCI-QOL Social Health Domain from baseline to post training/orientation, two months post intervention, and 4 months post intervention. The Social Health Domain score is a sum of the SCI-QOL scores from the ability to participate in social roles and activities, satisfaction with social roles and activities, and independence item banks. Possible range of the Social Health Domain score is 78 to 191, with a higher score indicating higher social health.'}, {'measure': 'Change in SCI-QOL Positive Emotional Constraints', 'timeFrame': 'post training/orientation, two months post intervention, and 4 months post intervention.', 'description': 'Mean difference score in the SCI-QOL Positive Emotional Constraints from baseline to post training/orientation, two months post intervention, and 4 months post intervention. The Positive Emotional Constraints score is a sum of the SCI-QOL scores from the positive affect and well being, self-esteem, and resilience item banks. Possible range of the Positive Emotional Constraints score is 63 to 199, with a higher score indicating better emotional wellbeing.'}, {'measure': 'Change in SCI-QOL Negative Emotional Constraints', 'timeFrame': 'post training/orientation, two months post intervention, and 4 months post intervention.', 'description': 'Mean difference score in the SCI-QOL Negative Emotional Constraints from baseline to post training/orientation, two months post intervention, and 4 months post intervention. The Negative Emotional Constraints score is a sum of the SCI-QOL scores from the anxiety, depression, grief-loss, trauma, and stigma item banks. Possible range of the Negative Emotional Constraints score is 182 to 405, with a lower score indicating better emotional wellbeing.'}, {'measure': 'Change in SCI Functional Index (FI)', 'timeFrame': 'post training/orientation, two months post intervention, and 4 months post intervention.', 'description': 'Mean difference score in the SCI Functional Index (FI) from baseline to post training/orientation, two months post intervention, and 4 months post intervention. The SCI Function Index for physical function is a sum of the basic mobility, ambulation, fine motor, self-care, and wheelchair mobility item banks. Possible range of the SCI Functional Index is 188 to 408, with a higher score indicating better physical function.'}, {'measure': 'Change in Sleep Disturbance', 'timeFrame': 'post training/orientation, two months post intervention, and 4 months post intervention.', 'description': 'Mean difference T-score of the Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance from baseline to post training/orientation, two months post intervention, and 4 months post intervention. Possible range of the PROMIS is 28.9 to 76.5, with a higher score indicating more sleep disturbance.'}, {'measure': 'Change in Participant Impression of Severity', 'timeFrame': 'post training/orientation, two months post intervention, and 4 months post intervention.', 'description': 'Mean difference in the participant impression of severity of spinal cord injury from the Global Impression of Change Scale from baseline to post training/orientation, two months post intervention, and 4 months post intervention. Possible range of the participant impression of severity is 1 to 7, with a higher score indicating worse impression of severity of spinal cord injury.'}, {'measure': 'Change in Companion Impression of Severity', 'timeFrame': 'post training/orientation, two months post intervention, and 4 months post intervention.', 'description': 'Mean difference in the companion impression of severity of spinal cord injury from the Global Impression of Change Scale from baseline to post training/orientation, two months post intervention, and 4 months post intervention. Possible range of the companion impression of severity is 1 to 7, with a higher score indicating worse impression of severity of spinal cord injury.'}, {'measure': 'Bowel Evacuation Time', 'timeFrame': '4 months post intervention', 'description': 'Time spent to have a bowel movement per bowel day, over 7 days. Responses were collected using a 5-point likert scale with the following options: 5 to 15 minutes; 15 to 30 minutes; 30 to 60 minutes; 1 to 3 hours; more than 3 hours.'}, {'measure': 'Frequency of Bowel Evacuation Episodes', 'timeFrame': '4 months post intervention', 'description': 'Frequency of bowel movements over 7 days. Responses were collected using a 5-point Likert scale with the following options: 7 times or more; 5 to 6 times; 3 to 4 times; 1 to 2 times; none.'}, {'measure': 'Manual/Digit Stimulation for Bowel Movements', 'timeFrame': '4 months post intervention', 'description': 'Needed manual/digit stimulation for bowel movements over 7 days. Responses were collected using a 5-point Likert scale with the following options: none/never; only once; a few times; most times; every time.'}, {'measure': 'Oral Medications for Bowel Movements', 'timeFrame': '4 months post intervention', 'description': 'Required oral medications to help with bowel movements over 7 days. Responses were collected using a 5-point Likert scale with the following options: none/never; only once; a few times; most times; every time.'}, {'measure': 'Enemas or Irrigations for Bowel Movements', 'timeFrame': '4 months post intervention', 'description': 'Required enemas or irrigations to help with bowel movements over 7 days. Responses were collected using a 5-point Likert scale with the following options: none/never; only once; a few times; most times; every time.'}, {'measure': 'Bowel Control', 'timeFrame': '4 months post intervention', 'description': 'Bowel accidents over 7 days. Responses were collected using a 5-point Likert scale with the following options: no leakage or accidents; leakage or an accident 1-2 times; leakage or an accident 3-4 times; leakage or an accident 5-6 times; leakage or an accident 7 or more times.'}, {'measure': 'Stool Consistency', 'timeFrame': '4 months post intervention', 'description': 'Stool consistency by the Bristol Stool Scale over 7 days. The Bristol Stool Scale classifies stools into seven groups: separate hard lumps; sausage-shaped, but lumpy; like sausage, cracks on surface; like a snake, smooth and soft; soft blobs (passed easily); fluffy pieces, a mush stool; watery, entirely liquid.'}, {'measure': 'Change in Abdominal Fat Mass', 'timeFrame': 'post training/orientation, two months post intervention, and 4 months post intervention.', 'description': 'Change in visceral adipose tissue mass measured from bone density scan, in grams, from baseline to post training/orientation, two months post intervention, and 4 months post intervention'}, {'measure': 'Change in High Density Lipoprotein Cholesterol', 'timeFrame': 'post training/orientation, two months post intervention, and 4 months post intervention.', 'description': 'Change in high density lipoprotein cholesterol, in milligrams per deciliter (mg/dL), from baseline to post training/orientation, two months post intervention, and 4 months post intervention'}, {'measure': 'Change in Low Density Lipoprotein Cholesterol', 'timeFrame': 'post training/orientation, two months post intervention, and 4 months post intervention.', 'description': 'Change in low density lipoprotein cholesterol, in milligrams per deciliter (mg/dL), from baseline to post training/orientation, two months post intervention, and 4 months post intervention'}, {'measure': 'Change in Total Cholesterol', 'timeFrame': 'post training/orientation, two months post intervention, and 4 months post intervention.', 'description': 'Change in total cholesterol, in milligrams per deciliter (mg/dL), from baseline to post training/orientation, two months post intervention, and 4 months post intervention'}, {'measure': 'Change in Triglycerides', 'timeFrame': 'post training/orientation, two months post intervention, and 4 months post intervention.', 'description': 'Change in triglycerides, in milligrams per deciliter (mg/dL), from baseline to post training/orientation, two months post intervention, and 4 months post intervention'}, {'measure': 'Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)', 'timeFrame': 'post training/orientation, two months post intervention, and 4 months post intervention.', 'description': 'Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), from baseline to post training/orientation, two months post intervention, and 4 months post intervention. HOMA-IR= Fasting insulin (mIU/ml) x Fasting glucose (mg/dl) / 405.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Exoskeleton'], 'conditions': ['Spinal Cord Injury']}, 'referencesModule': {'references': [{'pmid': '39230903', 'type': 'RESULT', 'citation': 'Spungen AM, Dematt EJ, Biswas K, Jones KM, Mi Z, Snodgrass AJ, Morin K, Asselin PK, Cirnigliaro CM, Kirshblum S, Gorman PH, Goetz LL, Stenson K, White KT, Hon A, Sabharwal S, Kiratli BJ, Ota D, Bennett B, Berman JE, Castillo D, Lee KK, Eddy BW, Henzel MK, Trbovich M, Holmes SA, Skelton F, Priebe M, Kornfeld SL, Huang GD, Bauman WA. Exoskeletal-Assisted Walking in Veterans With Paralysis: A Randomized Clinical Trial. JAMA Netw Open. 2024 Sep 3;7(9):e2431501. doi: 10.1001/jamanetworkopen.2024.31501.'}]}, 'descriptionModule': {'briefSummary': 'Background Veterans with spinal cord injury (SCI) have many adverse secondary medical and quality of life (QOL) changes as a result of immobilization. Veterans with SCI who have completed rehabilitation after injury and are unable to ambulate receive a wheelchair as standard of care (SOC) for mobility. Powered exoskeletons are a technology that has recently become available as an alternate form of mobility by providing an external framework for support and computer controlled motorized hip and knee joints to assist with over ground ambulation.', 'detailedDescription': 'Administrative hold due to COVID-19 pandemic.\n\nBackground Veterans with spinal cord injury (SCI) have many adverse secondary medical and quality of life (QOL) changes as a result of immobilization. Veterans with SCI who have completed rehabilitation after injury and are unable to ambulate receive a wheelchair as standard of care (SOC) for mobility. Powered exoskeletons are a technology that has recently become available as an alternate form of mobility by providing an external framework for support and computer controlled motorized hip and knee joints to assist with overground ambulation.\n\nResearch Questions (Objectives) Will Veterans with chronic SCI of six months duration, who are medically stable and who use a wheelchair as SOC plus an exoskeletal-assisted walking (EAW) device in their home and community environments have clinically meaningful net improvements in mental health, bladder, bowel, and pain patient-reported outcomes compared with those who use only the SOC? Additionally, will the use of an EAW device for four months in the homes and/or communities of the participants result in a reduction of total body fat mass? Study Design A two-group (Intervention and Control), randomized, clinical trial will be performed with a one-year feasibility component. The Intervention group will receive SOC plus EAW. The Control group will receive SOC only. The study will require seven years in total to complete and includes fifteen VA SCI Services as study sites. A feasibility phase will be employed using a staggered start by initially starting six sites, four sites starting one year later, and 5 other sites starting two years later. These initial six sites will be used to assess the start-up activities \\[hiring, training, equipment procurement, Central Institutional Review Board (CIRB) paperwork, etc.\\], the rate of recruitment, and any other issues that may be of value for the successful completion of the study. Lessons learned will be implemented for the remaining sites.\n\nRelevance to VA In pilot studies conducted at the James J. Peters VA Medical Center, Bronx, NY, improvements in mental-emotional health, physical health and body composition were demonstrated by providing the participants the ability to walk for 4 to 6 hours per week over the course of three to five months. As of July 2014, a Class 2 designation was established by the Food and Drug Administration (FDA) for "powered exoskeletons". To date, one device (ReWalk ) has received FDA Class 2 approval for institutional and home use and is currently available by prescription. The Department of Veterans Affairs (DVA) is the largest single provider to persons with SCI in the USA, caring for about 26,000 of the 42,000 estimated Veterans with SCI. The VA presently lacks the infrastructure to support Veterans with SCI to train to use this device in order to make this technology available for the home/community use. A controlled research study would be anticipated to be the optimal manner to demonstrate the efficacy, amount of use and safety of a powered exoskeleton in the home and community environments; findings would be immediately transferable to clinical care.\n\nNumber of Research Participants (Sample Size) One hundred-sixty participants (80/group) will be randomized. Each of the 15 study sites will be expected to pre-screen 100 potential participants, screen 60 participants, to reach the target of 160 randomized over 15 sites.\n\nParticipating Sites Fifteen SCI Services will be selected on the basis of potential recruitment numbers (N=13,606 total Veterans with SCI in the sites\' catchment areas and N=7,022 followed annually at these sites) and geographic location, to permit an even distribution across the country. The fifteen sites include: Boston, Richmond, St. Louis, Tampa, Milwaukee, Minneapolis, Dallas, Houston, Palo Alto, Long Beach, Augusta, San Antonio, Bronx, Cleveland, and Albuquerque. Of these fifteen sites, five are VA Cooperative Studies Program (CSP) Network of Dedicated Enrollment Sites (NODES).\n\nDuration of Participant Intake (Study Duration) The CS #2003 study duration is projected to be a total of seven years: The initial six sites will have a start-up year, followed by participant enrollment/data collection during years 1-4, and continued data collection/closeout during year 5, for a total of six years. The next four sites will begin the start-up year one year after the first six sites and follow the same enrollment, data collection and closeout schedule over the next five years. The next five sites will begin start-up one year after the four sites and follow the same enrollment, data collection and closeout schedule. All fifteen sites will be closed out after six years, and there is an additional year for the Coordinating Center and Chairperson\'s Office to complete data analysis and manuscript writing, thus the study total time is seven years. Participants in both groups will be asked to commit 33 weeks to this study. Participants in the Control arm will be offered an additional 8 weeks to receive EAW training in the medical centers, without outcome data being collected.\n\nTreatment (follow-up) The intervention being tested is four months of home and/or community use of a powered exoskeleton.\n\nDefinition of Participant Samples (Study Population) One-hundred sixty male or female Veterans or military members with chronic SCI, six months duration, 18 years of age, functional use of their hands, medically stable, and wheelchair users for indoor and outdoor mobility, will be eligible for screening. All potential participants will be Veterans or military members with SCI. Study participants will generally be outpatients with the exception of those inpatients who meet the eligibility criteria, and who are approved by the Site Investigator (e.g., some inpatients may have been admitted for a wheelchair fitting or another non-medical reason). Non-veterans with SCI will not be eligible.\n\nTreatment Arms All participants will receive four months of treatment, randomized into two arms: SOC plus EAW or SOC only.\n\nEndpoints Primary outcome one will be the Mental Component Summary of the Veterans Rand-36 (MCS/VR-36). Primary outcome two will be the sum T-score of the SCI-QOL bladder management difficulties, bowel management difficulties and pain interference item banks. The major secondary outcome will be total body fat mass. The two primary and the major secondary outcomes will be analyzed as the proportion of participants in each group who achieved a clinically meaningful change in score. The endpoint will be success or failure for these outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Veterans or active duty military personnel who are at least 18 years of age;\n2. Traumatic or non-traumatic SCI 6 months duration of SCI;\n3. Wheelchair-user for indoor and outdoor mobility;\n4. Anthropometric compatibility with the device:\n\n 1. Weight \\<220 lb. (100 kg),\n 2. Thigh length between 14 and 19 in (36 and 48 cm),\n 3. Shank length between 17 and 22 in (43 and 55 cm);\n5. Able to hold the crutches in hands without modifications;\n6. Able to have a companion who can attend approximately one-third of the training sessions who will assist them at home and in the community; and\n7. Able to provide informed consent.\n\nExclusion Criteria:\n\n1. Diagnosis of neurological injury other than SCI;\n2. Progressive condition that would be expected to result in changing neurological status;\n3. Severe concurrent medical disease, illness or condition judged to be contraindicated by the Site Physician;\n4. Unhealed or unstable traumatic or high impact lower extremity fracture (definition below) of any duration that is in the clinical judgement of the study physician to be exclusionary for standing and walking;\n5. Knee BMD \\< 0.60 gm/cm2;\n6. Total hip BMD T-scores \\< -3.5;\n7. Fragility, minimal trauma or low impact fracture of the lower extremity since spinal cord injury (definition below);\n8. Untreatable severe spasticity judged to be contraindicated by the Site Physician;\n9. Flexion contracture \\> 15 degrees at the hip and/or \\> 10 degrees at the knee;\n10. Limitations in ankle range of motion that cannot be adapted with an orthotic device (plantar flexion \\> 00);\n11. Untreated or uncontrolled hypertension (systolic blood pressure \\>140 mmHg; diastolic blood pressure \\>90 mmHg);\n12. Unresolved orthostatic hypotension (systolic blood pressure \\<90 mmHg; diastolic blood pressure \\<60 mmHg) as judged to be contraindicated by the Site Physician;\n13. Current pressure ulcer of the arms, trunk, pelvic area, or lower extremities;\n14. Psychopathology documentation in the medical record or history that may conflict with study objectives; and/or\n15. Pregnancy or women who plan to become pregnant during the study period.'}, 'identificationModule': {'nctId': 'NCT02658656', 'acronym': '(PEPSCI)', 'briefTitle': 'Powered Exoskeletons in Persons With SCI', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'CSP #2003 - Exoskeleton Assisted-Walking in Persons With SCI: Impact on Quality of Life', 'orgStudyIdInfo': {'id': '2003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Exoskeleton + Standard of Care (SOC)', 'description': 'Patient will receive exoskeletal-assisted walking device for in home use for 4 months', 'interventionNames': ['Device: ReWalk 6.0']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care (SOC)', 'description': 'Patient will receive standard of care (wheelchair use)'}], 'interventions': [{'name': 'ReWalk 6.0', 'type': 'DEVICE', 'description': 'Exoskeletal Assisted Walking Device', 'armGroupLabels': ['Exoskeleton + Standard of Care (SOC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90822', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'VA Long Beach Healthcare System, Long Beach, CA', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '94304-1290', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'VA Palo Alto Health Care System, Palo Alto, CA', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': "James A. Haley Veterans' Hospital, Tampa, FL", 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30904', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Charlie Norwood VA Medical Center, Augusta, GA', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '02130', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55417', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minneapolis VA Health Care System, Minneapolis, MN', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '63106', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Louis VA Medical Center John Cochran Division, St. Louis, MO', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '87108-5153', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'New Mexico VA Health Care System, Albuquerque, NM', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '10468-3904', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'James J. Peters VA Medical Center, Bronx, NY', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Louis Stokes VA Medical Center, Cleveland, OH', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '75216', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Michael E. DeBakey VA Medical Center, Houston, TX', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'South Texas Health Care System, San Antonio, TX', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23249', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Hunter Holmes McGuire VA Medical Center, Richmond, VA', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '53295-1000', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Clement J. Zablocki VA Medical Center, Milwaukee, WI', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Ann M Spungen, EdD', 'role': 'STUDY_CHAIR', 'affiliation': 'James J. Peters Veterans Affairs Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual Participant Data will not be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}