Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-02-21 @ 10:33 AM
Study NCT ID:
NCT03906656
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2019-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Trial Comparing C-Brace to Knee Ankle Foot Orthosis (KAFO)/Stance Control Orthosis (SCO)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010291', 'term': 'Paresis'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'russ.lundstrom@ottobock.com', 'phone': '6127182025', 'title': 'Russ Lundstrom', 'organization': 'Ottobock'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The study was affected by the COVID pandemic. Home-use periods interrupted by the pandemic were restarted, and the study was re-opened for enrollment of another 59 subjects. Neither the subjects nor investigators were blinded for interventions. Only subjects with impaired balance (BBS\\<45) were included. It is unclear whether the amount of device training was sufficient.'}}, 'adverseEventsModule': {'timeFrame': 'For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.', 'description': 'For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.', 'eventGroups': [{'id': 'EG000', 'title': 'KAFO/SCO', 'description': 'Home use of 3 months with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO). May also include a period of time when the C-Brace was being fabricated prior to the C-Brace home use of 3 months.\n\nKAFO/SCO: Current knee ankle foot orthosis that the subject was wearing at baseline', 'otherNumAtRisk': 102, 'deathsNumAtRisk': 102, 'otherNumAffected': 66, 'seriousNumAtRisk': 102, 'deathsNumAffected': 0, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'C-Brace', 'description': "Home use of 3 months with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.\n\nC-Brace: The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint.", 'otherNumAtRisk': 88, 'deathsNumAtRisk': 88, 'otherNumAffected': 57, 'seriousNumAtRisk': 88, 'deathsNumAffected': 2, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Indigestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Increased fall frequency', 'notes': 'A significant increase in falls when comparing one home use period to another', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Sponsor'}, {'term': 'Swelling of legs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Immunodeficiency syndromes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Multiple sclerosis aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Candida infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cold symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Flu', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Klebsiella Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Stomach Virus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injurious Fall', 'notes': 'A complete fall, all the way to the ground, that resulted in an injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 37, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 15, 'numAffected': 10}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Sponsor'}, {'term': 'Open Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tendon injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ankle sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fibula Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Foot Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Joint Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Juvenile idiopathic arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Leg Cramps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Muscle Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Muscular Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain in foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain in hip', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain in leg', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain in toe', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Patella Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Post polio syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Shoulder Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dysaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Additional strap necessary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Sponsor'}, {'term': 'Alignment Issue', 'notes': "A mismatch between the alignment of the orthosis and the subject's physiologic limb", 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Sponsor'}, {'term': 'Battery holder defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Sponsor'}, {'term': 'Beeping', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Sponsor'}, {'term': 'Bluetooth Malfunction', 'notes': 'Connectivity issues to the orthosis via the phone app', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Sponsor'}, {'term': 'Broken Spring', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Sponsor'}, {'term': 'Broken Strap', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Sponsor'}, {'term': 'Broken foot stirrup', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Sponsor'}, {'term': 'Charging Malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Sponsor'}, {'term': 'Clicking/cracking noises', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Sponsor'}, {'term': 'Delamination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Sponsor'}, {'term': 'Foot plate fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Sponsor'}, {'term': 'Insufficient Padding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Sponsor'}, {'term': 'Joint Malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Sponsor'}, {'term': 'Loose Screw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Sponsor'}, {'term': 'Loss of oil', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Sponsor'}, {'term': 'Modified foot plate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Sponsor'}, {'term': 'Poor Fit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Sponsor'}, {'term': 'Service Light', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Sponsor'}, {'term': 'Unexpected mode switch', 'notes': 'Either switching to a freeze/safety mode, or free swing unexpectedly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vaginal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nail bed inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Skin Abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Intestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cholecystolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hip Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasal septum deviation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Systemic scleroderma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hand operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Efficacy: Berg Balance Scale (BBS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Baseline measure with currently worn knee ankle foot orthosis (KAFO) or stance control orthosis (SCO)'}, {'id': 'OG001', 'title': 'KAFO', 'description': 'Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)'}, {'id': 'OG002', 'title': 'C-Brace', 'description': "Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.\n\nC-Brace: The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint."}], 'classes': [{'categories': [{'measurements': [{'value': '33.6', 'spread': '11.0', 'groupId': 'OG000'}, {'value': '37.3', 'spread': '10.5', 'groupId': 'OG001'}, {'value': '42.0', 'spread': '9.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '3.5', 'pValueComment': 'Adjusted p-values based on Holm-Bonferroni method. P-values \\< 0.05 used as threshold for statistical significance.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '8.1', 'estimateComment': 'Mean difference is for paired data (n=73). This explains the discrepancy between the mean difference and the difference between the KAFO and C-Brace means (n=86 and n=77, respectively).', 'groupDescription': 'H0: the mean difference (C-Brace - KAFO) \\<= 0.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.00001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '6.8', 'pValueComment': 'Adjusted p-values based on Holm-Bonferroni method. P-values \\< 0.05 used as threshold for statistical significance.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '9.7', 'estimateComment': 'Mean difference is for paired data (n=77). This explains the discrepancy between the mean difference and the difference between the KAFO and C-Brace means (n=86 and n=77, respectively).', 'groupDescription': 'H0: the mean difference (C-Brace - Baseline) \\<= 0.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.00001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '3.3', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '6.3', 'estimateComment': 'Mean difference is for paired data (n=86). This explains the discrepancy between the mean difference and the difference between the Baseline and KAFO means (n=102 and n=86, respectively).', 'groupDescription': 'KAFO vs. Baseline -- H0: the mean difference (KAFO - Baseline) \\<= 0.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months after initial home use period, and 3 months after cross-over home use period', 'description': "The Berg Balance Scale is a 14-item scale designed to measure static and dynamic balance in adults in a clinical setting. The range in score for the BBS is 0 to 56, with higher scores indicating better balance. Points for each item are deducted if the time or distance requirements are not met, the patient's performance requires supervision, or the patient requires assistance from support or examiner.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat Analysis'}, {'type': 'SECONDARY', 'title': 'Activity-specific Balance Confidence (ABC) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Baseline measure with currently worn knee ankle foot orthosis (KAFO) or stance control orthosis (SCO)'}, {'id': 'OG001', 'title': 'KAFO', 'description': 'Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)'}, {'id': 'OG002', 'title': 'C-Brace', 'description': "Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.\n\nC-Brace: The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint."}], 'classes': [{'categories': [{'measurements': [{'value': '53.1', 'spread': '19.2', 'groupId': 'OG000'}, {'value': '51.0', 'spread': '18.3', 'groupId': 'OG001'}, {'value': '62.3', 'spread': '19.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '7.05', 'pValueComment': 'P-value not adjusted for multiple comparisons. P-values \\< 0.05 used as threshold for statistical significance.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '26.3', 'groupDescription': 'H0: the mean difference (C-Brace - KAFO) \\<= 0', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '63.6 degrees of freedom.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months after initial home use period, and 3 months after cross-over home use period', 'description': 'Assessment of patient-perceived balance confidence for 16 activities of daily living. For each activity, subjects rate their level of confidence in doing the activity without losing their balance or becoming unsteady on a scale from 0% to 100%, with 100% being the highest level of confidence. The total score for the ABC scale is an average of all activity scores.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat Group'}, {'type': 'SECONDARY', 'title': 'Dynamic Gait Index (DGI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Baseline measure with currently worn knee ankle foot orthosis (KAFO) or stance control orthosis (SCO)'}, {'id': 'OG001', 'title': 'KAFO', 'description': 'Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)'}, {'id': 'OG002', 'title': 'C-Brace', 'description': "Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.\n\nC-Brace: The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint."}], 'classes': [{'categories': [{'measurements': [{'value': '12.3', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '13.4', 'spread': '3.2', 'groupId': 'OG001'}, {'value': '15.7', 'spread': '3.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.0', 'pValueComment': 'P-values not adjusted for multiple comparisons. P-values \\< 0.05 used as threshold for statistical significance.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '3.7', 'groupDescription': 'H0: the mean difference (C-Brace - KAFO) \\<= 0.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '74.4 degrees of freedom', 'nonInferiorityComment': 'P-values not adjusted for multiple comparisons. P-values \\< 0.05 used as threshold for statistical significance.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months after initial home use period, and 3 months after cross-over home use period', 'description': 'An 8-item test used to assess balance during walking tasks. It has a maximum score of 24 with each item being scored 0-3. A higher score indicates greater balance, and subjects lose a a point on all items for which an assistive device is needed.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat Group'}, {'type': 'SECONDARY', 'title': '6-minute Walk Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Baseline measure with currently worn knee ankle foot orthosis (KAFO) or stance control orthosis (SCO)'}, {'id': 'OG001', 'title': 'KAFO', 'description': 'Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)'}, {'id': 'OG002', 'title': 'C-Brace', 'description': "Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.\n\nC-Brace: The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint."}], 'classes': [{'categories': [{'measurements': [{'value': '204.9', 'spread': '73.9', 'groupId': 'OG000'}, {'value': '213.7', 'spread': '80.9', 'groupId': 'OG001'}, {'value': '226.0', 'spread': '84.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.583', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.185', 'pValueComment': 'P-values not adjusted for multiple comparisons. P-values \\< 0.05 used as threshold for statistical significance.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '53.6', 'groupDescription': 'H0: the median of the population differences (C-Brace - KAFO) \\<= 0.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'Wilcoxon Signed Rank Test. V=1207.5, effect size r = 0.026, p=0.583.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months after initial home use period, and 3 months after cross-over home use period', 'description': 'Distance walked in 6 minutes over 12-meter back-and-forth pathway as a measure of functional exercise capacity.', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat Group'}, {'type': 'SECONDARY', 'title': 'Stair Assessment Index (SAI) - Down', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Baseline measure with currently worn knee ankle foot orthosis (KAFO) or stance control orthosis (SCO)'}, {'id': 'OG001', 'title': 'KAFO', 'description': 'Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)'}, {'id': 'OG002', 'title': 'C-Brace', 'description': "Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.\n\nC-Brace: The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint."}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '3.5', 'groupId': 'OG001'}, {'value': '6', 'spread': '4.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0078', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.28', 'pValueComment': 'P-values not adjusted for multiple comparisons. P-values \\< 0.05 used as threshold for statistical significance.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '4.37', 'groupDescription': 'H0: the median of the population differences (C-Brace - KAFO) \\<= 0. (SAI - Down)', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'Wilcoxon Signed Rank Test V=438, effect size r = 0.21, p=0.008'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months after initial home use period, and 3 months after cross-over home use period', 'description': 'A 14-point ordinal scale (0 - 13) used to assess different gait patterns during descent of stairs. The range of total scores for the SAI is from 0 to 26, with a higher score indicating a more normative gait pattern and needing less assistance.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat Group'}, {'type': 'SECONDARY', 'title': 'Frequency of Falling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Baseline measure with currently worn knee ankle foot orthosis (KAFO) or stance control orthosis (SCO)'}, {'id': 'OG001', 'title': 'KAFO', 'description': 'Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)'}, {'id': 'OG002', 'title': 'C-Brace', 'description': "Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.\n\nC-Brace: The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint."}], 'classes': [{'categories': [{'measurements': [{'value': '4.9', 'spread': '20.1', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '16.8', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '3.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0020', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-3.41', 'pValueComment': 'P-values not adjusted for multiple comparisons. P-values \\< 0.05 used as threshold for statistical significance.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '17.0', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'Wilcoxon Signed Rank Test V=267, effect size r = 0.32, p=0.002'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months after initial home use period, and 3 months after cross-over home use period', 'description': 'Frequency of falling by using C-Brace compared to KAFO/SCO as measured by the number of falls in 3-month period by recollection at baseline and recorded in a Falls Diary during home-use periods', 'unitOfMeasure': 'number of falls in a three month period', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat Group'}, {'type': 'SECONDARY', 'title': 'Fear of Falling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Baseline measure with currently worn knee ankle foot orthosis (KAFO) or stance control orthosis (SCO)'}, {'id': 'OG001', 'title': 'KAFO', 'description': 'Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)'}, {'id': 'OG002', 'title': 'C-Brace', 'description': "Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.\n\nC-Brace: The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint."}], 'classes': [{'title': 'Fear of falling indoors', 'categories': [{'measurements': [{'value': '3.3', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '2.8', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '2.6', 'groupId': 'OG002'}]}]}, {'title': 'Fear of falling outdoors', 'categories': [{'measurements': [{'value': '5.5', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '2.9', 'groupId': 'OG001'}, {'value': '4.4', 'spread': '3.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0023', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.11', 'pValueComment': 'P-values not adjusted for multiple comparisons. P-values \\< 0.05 used as threshold for statistical significance.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '3.178', 'groupDescription': 'H0: the median of the population differences (C-Brace - KAFO) \\<= 0. (Fear of falling - indoors)', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'Wilcoxon Signed Rank Test V=433, effect size r = 0.33, p=0.002'}, {'pValue': '0.0066', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.973', 'pValueComment': 'P-values not adjusted for multiple comparisons. P-values \\< 0.05 used as threshold for statistical significance.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '3.43', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'Wilcoxon Signed Rank Test V=557.5, effect size r = 0.265, p=0.0066'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months after initial home use period, and 3 months after cross-over home use period', 'description': "Two questions on patients' fear of falling indoors and outdoors based on an 11-point scale (0 = no fear, 10 = max. fear). The total score will range from 0 to 20, with 20 being maximum fear of falling.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat Group'}, {'type': 'SECONDARY', 'title': 'Probability of Falling More Than Once When Using C-Brace Compared to KAFO/SCO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'KAFO', 'description': 'Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO).'}, {'id': 'OG001', 'title': 'C-Brace', 'description': "Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.\n\nC-Brace: The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint."}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value not adjusted for multiple comparisons', 'groupDescription': 'Paired dataset. H0: The probability of fallers wearing C-Brace becoming non-fallers wearing KAFO is the same as the probability of non-fallers wearing C-Brace becoming fallers wearing KAFO.', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months after initial home use period, and 3 months after cross-over home use period', 'description': 'Proportion of subjects having reported falling more than once will be compared between KAFO and C-Brace home-use periods', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Paired data including subjects with fall history after both KAFO and C-Brace home use periods'}, {'type': 'SECONDARY', 'title': 'Reintegration to Normal Living (RNL) Index Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Baseline measure with currently worn knee ankle foot orthosis (KAFO) or stance control orthosis (SCO)'}, {'id': 'OG001', 'title': 'KAFO', 'description': 'Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)'}, {'id': 'OG002', 'title': 'C-Brace', 'description': "Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.\n\nC-Brace: The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint."}], 'classes': [{'categories': [{'measurements': [{'value': '71.5', 'spread': '19.8', 'groupId': 'OG000'}, {'value': '71.7', 'spread': '17.6', 'groupId': 'OG001'}, {'value': '74.0', 'spread': '19.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.08', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '2.82', 'pValueComment': 'P-values not adjusted for multiple comparisons. P-values \\< 0.05 used as threshold for statistical significance.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '16.4', 'groupDescription': 'H0: the median of the population differences (C-Brace - KAFO) \\<= 0.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'Wilcoxon Signed Rank Test. V=1325.5, effect size r = 0.181, p=0.08.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months after initial home use period, and 3 months after cross-over home use period', 'description': '11 items measuring satisfaction regarding perceived physical functioning, and social and emotional life. Higher scores represent higher levels of participation. The range of the adjusted total score is 0 to 100.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat Group'}, {'type': 'SECONDARY', 'title': 'EQ-5D-5L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Baseline measure with currently worn knee ankle foot orthosis (KAFO) or stance control orthosis (SCO)'}, {'id': 'OG001', 'title': 'KAFO', 'description': 'Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)'}, {'id': 'OG002', 'title': 'C-Brace', 'description': "Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.\n\nC-Brace: The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint."}], 'classes': [{'categories': [{'measurements': [{'value': '0.71', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '0.72', 'spread': '0.19', 'groupId': 'OG001'}, {'value': '0.74', 'spread': '0.18', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.151', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.009', 'pValueComment': 'P-values not adjusted for multiple comparisons. P-values \\< 0.05 used as threshold for statistical significance.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.184', 'estimateComment': 'Wilcoxon Signed Rank Test V=1124.5, effect size r = 0.125 p=0.151', 'groupDescription': 'H0: the median of the population differences (C-Brace - KAFO) \\<= 0', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months after initial home use period, and 3 months after cross-over home use period', 'description': 'Measure of health status composed of 5 dimensions: mobility, ability to self-care, ability to undertake usual activities, pain and discomfort, anxiety and depression. Each dimension is rated on a 5-point scale indicating the level of perceived problems for each dimension (level 1 indicating no problems and level 5 indicating extreme problems). The raw score is then aggregated and normalized based on region to a 0 to 1 scale (where 0 represents maximum issues and 1 represents no problems).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat Group'}, {'type': 'SECONDARY', 'title': 'Work Limitations Questionnaires WLQ-25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Baseline measure with currently worn knee ankle foot orthosis (KAFO) or stance control orthosis (SCO)'}, {'id': 'OG001', 'title': 'KAFO', 'description': 'Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)'}, {'id': 'OG002', 'title': 'C-Brace', 'description': "Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.\n\nC-Brace: The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint."}], 'classes': [{'title': 'Mental/Interpersonal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '86.1', 'spread': '13.3', 'groupId': 'OG000'}, {'value': '88.4', 'spread': '11.5', 'groupId': 'OG001'}, {'value': '91.0', 'spread': '13.7', 'groupId': 'OG002'}]}]}, {'title': 'Output', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '82.0', 'spread': '17.9', 'groupId': 'OG000'}, {'value': '81.9', 'spread': '17.0', 'groupId': 'OG001'}, {'value': '84.6', 'spread': '17.3', 'groupId': 'OG002'}]}]}, {'title': 'Physical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '37.5', 'spread': '24.8', 'groupId': 'OG000'}, {'value': '34.5', 'spread': '23.3', 'groupId': 'OG001'}, {'value': '24.3', 'spread': '18.8', 'groupId': 'OG002'}]}]}, {'title': 'Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '79.2', 'spread': '20.1', 'groupId': 'OG000'}, {'value': '78.3', 'spread': '24.6', 'groupId': 'OG001'}, {'value': '79.8', 'spread': '19.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.281', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-2.10', 'pValueComment': 'P-values not adjusted for multiple comparisons. P-values \\< 0.05 used as threshold for statistical significance.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '21.5', 'groupDescription': 'WLQ-25 - Physical', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '16.7 degrees of freedom', 'nonInferiorityComment': 'H0: the mean of the population differences (C-Brace - KAFO) \\>= 0'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months after initial home use period, and 3 months after cross-over home use period', 'description': '25-item questionnaire to evaluate at-work disability and productivity loss under four sub-scales: time demands, physical demands, mental/interpersonal demands, and output demands. Scale scores range from 0 (limited none of the time) to 100 (limited all of the time).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat Group. If one or more items in a subscale were not answered, the patient was excluded from the analysis of that particular subscale.'}, {'type': 'SECONDARY', 'title': 'Orthotics & Prosthetics User Survey (OPUS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Baseline measure with currently worn knee ankle foot orthosis (KAFO) or stance control orthosis (SCO)'}, {'id': 'OG001', 'title': 'KAFO', 'description': 'Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)'}, {'id': 'OG002', 'title': 'C-Brace', 'description': "Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.\n\nC-Brace: The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint."}], 'classes': [{'title': 'Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '56.6', 'spread': '7.3', 'groupId': 'OG000'}, {'value': '56.9', 'spread': '6.9', 'groupId': 'OG001'}, {'value': '58.0', 'spread': '8.0', 'groupId': 'OG002'}]}]}, {'title': 'Lower Extremity Functional Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '45.3', 'spread': '6.2', 'groupId': 'OG000'}, {'value': '46.6', 'spread': '6.3', 'groupId': 'OG001'}, {'value': '48.8', 'spread': '6.3', 'groupId': 'OG002'}]}]}, {'title': 'Satisfaction with Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '49.8', 'spread': '10.5', 'groupId': 'OG000'}, {'value': '50.6', 'spread': '9.7', 'groupId': 'OG001'}, {'value': '51.3', 'spread': '13.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.00019', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.99', 'pValueComment': 'P-values not adjusted for multiple comparisons. P-values \\< 0.05 used as threshold for statistical significance.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5.18', 'groupDescription': 'OPUS - Low Extremity Functional Status. H0: the mean difference (C-Brace - KAFO) \\<= 0', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '48.4 degrees of freedom'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months after initial home use period, and 3 months after cross-over home use period', 'description': 'A self-report questionnaire designed to evaluate the outcome of orthotic and prosthetic services. Three of the five domains will be administered: lower extremity functional status (20 items, score ranges from 0 - 80, with high score being easier), health-related quality of life index (23 items, score ranges from 0 - 92, with higher score being better) and satisfaction with device (11 items, score ranges from 11 - 55, with higher score being more satisfaction) scales. The domains of upper limb functional measure and satisfaction with service are not applicable in this study.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat Group. If one or more items in a subscale were not answered, the patient was excluded from the analysis of that particular subscale.'}, {'type': 'SECONDARY', 'title': 'Medical Outcomes Study Short Form (SF-36)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Baseline measure with currently worn knee ankle foot orthosis (KAFO) or stance control orthosis (SCO)'}, {'id': 'OG001', 'title': 'KAFO', 'description': 'Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)'}, {'id': 'OG002', 'title': 'C-Brace', 'description': "Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.\n\nC-Brace: The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint."}], 'classes': [{'title': 'Emotional Wellbeing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '76.2', 'spread': '16.4', 'groupId': 'OG000'}, {'value': '75.5', 'spread': '16.3', 'groupId': 'OG001'}, {'value': '79.2', 'spread': '15.16', 'groupId': 'OG002'}]}]}, {'title': 'Energy/Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '52.2', 'spread': '21.3', 'groupId': 'OG000'}, {'value': '52.3', 'spread': '20.3', 'groupId': 'OG001'}, {'value': '56.8', 'spread': '20.1', 'groupId': 'OG002'}]}]}, {'title': 'General Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '54.1', 'spread': '22.2', 'groupId': 'OG000'}, {'value': '54.2', 'spread': '23.8', 'groupId': 'OG001'}, {'value': '58.2', 'spread': '23.8', 'groupId': 'OG002'}]}]}, {'title': 'Health Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '47.4', 'spread': '24.2', 'groupId': 'OG000'}, {'value': '48.0', 'spread': '26.0', 'groupId': 'OG001'}, {'value': '56.5', 'spread': '26.4', 'groupId': 'OG002'}]}]}, {'title': 'Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '55.6', 'spread': '25.3', 'groupId': 'OG000'}, {'value': '57.4', 'spread': '24.9', 'groupId': 'OG001'}, {'value': '59.5', 'spread': '26.7', 'groupId': 'OG002'}]}]}, {'title': 'Physical Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '29.7', 'spread': '22.6', 'groupId': 'OG000'}, {'value': '31.1', 'spread': '23.8', 'groupId': 'OG001'}, {'value': '44.3', 'spread': '23.3', 'groupId': 'OG002'}]}]}, {'title': 'Role limitations due to emotional problems', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '78.1', 'spread': '36.9', 'groupId': 'OG000'}, {'value': '82.2', 'spread': '34.3', 'groupId': 'OG001'}, {'value': '86.1', 'spread': '28.8', 'groupId': 'OG002'}]}]}, {'title': 'Role limitations due to physical health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '36.5', 'spread': '39.7', 'groupId': 'OG000'}, {'value': '44.9', 'spread': '43.2', 'groupId': 'OG001'}, {'value': '51.0', 'spread': '41.2', 'groupId': 'OG002'}]}]}, {'title': 'Social Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '74.2', 'spread': '23.0', 'groupId': 'OG000'}, {'value': '75.1', 'spread': '25.0', 'groupId': 'OG001'}, {'value': '77.3', 'spread': '24.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0226', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '3.19', 'pValueComment': 'P-values not adjusted for multiple comparisons. P-values \\< 0.05 used as threshold for statistical significance.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '15.0', 'groupDescription': 'Emotional well-being. H0: the mean difference (C-Brace - KAFO) \\<= 0.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '22.1 degrees of freedom'}, {'pValue': '0.0020', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '6.79', 'pValueComment': 'P-values not adjusted for multiple comparisons. P-values \\< 0.05 used as threshold for statistical significance.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '21.1', 'groupDescription': 'Energy/Fatigue. H0: the mean difference (C-Brace - KAFO) \\<= 0.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0049', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '10.1', 'pValueComment': 'P-values not adjusted for multiple comparisons. P-values \\< 0.05 used as threshold for statistical significance.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '29.528', 'groupDescription': 'Health change. H0: the median of the population differences (C-Brace - KAFO) \\<= 0.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'Wilcoxon Signed Rank Test. V=649, effect size r = 0.285, p=0.00493'}, {'pValue': '0.0000647', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '12.6', 'pValueComment': 'P-values not adjusted for multiple comparisons. P-values \\< 0.05 used as threshold for statistical significance.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '29.2', 'groupDescription': 'Physical Functioning Score. H0: the mean difference (C-Brace - KAFO) \\<= 0', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '37.35 degrees of freedom'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months after initial home use period, and 3 months after cross-over home use period', 'description': '36-item scale constructed to survey health status and quality of life. It assesses eight health concept scales: physical functioning, role functioning/physical, role functioning/emotional, energy/fatigue, emotional well-being, social functioning, pain and general health. Each scale score ranges from 0 to 100 with 100 being the highest (better) score.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat Group. If one or more items in a subscale were not answered, the patient was excluded from the analysis of that particular subscale.'}, {'type': 'SECONDARY', 'title': 'Quebec User Evaluation on Satisfaction With Assistive Technology (QUEST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Baseline measure with currently worn knee ankle foot orthosis (KAFO) or stance control orthosis (SCO)'}, {'id': 'OG001', 'title': 'KAFO', 'description': 'Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)'}, {'id': 'OG002', 'title': 'C-Brace', 'description': "Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.\n\nC-Brace: The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint."}], 'classes': [{'title': 'Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.05', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '4.05', 'spread': '0.72', 'groupId': 'OG001'}, {'value': '4.00', 'spread': '0.63', 'groupId': 'OG002'}]}]}, {'title': 'Service', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.60', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '4.66', 'spread': '0.70', 'groupId': 'OG001'}, {'value': '4.79', 'spread': '0.42', 'groupId': 'OG002'}]}]}, {'title': 'Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.23', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '4.27', 'spread': '0.64', 'groupId': 'OG001'}, {'value': '4.27', 'spread': '0.49', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.301', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.28', 'pValueComment': 'P-values not adjusted for multiple comparisons. P-values \\< 0.05 used as threshold for statistical significance.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.843', 'groupDescription': 'Device. H0: the median of the population differences (C-Brace - KAFO) \\<= 0', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'Wilcoxon Signed Rank Test V=1018.5, effect size r = 0.056, p=0.301'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months after initial home use period, and 3 months after cross-over home use period', 'description': '12-item instrument used to assess satisfaction with a specific assistive device. Each questions is rated on a 5-point scale, with 1=not satisfied at all and 5=very satisfied. The first 8 questions comprise the Device subscale and the last 4, the Services subscale. Each subscale and the total score are presented as averages ranging from 1 to 5, with higher scores representing greater satisfaction.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat Group. If one or more items in a subscale were not answered, the patient was excluded from the analysis of that particular subscale.'}, {'type': 'SECONDARY', 'title': 'Patient-Related Outcome Questions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'KAFO/SCO, Then C-Brace', 'description': 'Home use of 3 months with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)\n\nKAFO/SCO: Current knee ankle foot orthosis that the subject was wearing at baseline\n\nCrossover immediately after first home-use period to being fit with C-Brace, receiving training, and starting 3-month home-use period as soon as the subject demonstrates he/she is able to use it safely.'}, {'id': 'OG001', 'title': 'C-Brace, Then KAFO/SCO', 'description': "Home use of 3 months with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.\n\nC-Brace: The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint.\n\nCrossover to wearing previous KAFO/SCO, receives training if necessary, wears KAFO/SCO for a 1-month washout period then starting 3-month KAFO/SCO home-use period."}], 'classes': [{'title': 'To what extent has the C-Brace enabled you to engage in the activities that you enjoy?', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '4'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '3.75', 'upperLimit': '5'}]}]}, {'title': 'To what extent has the C-Brace impacted your quality of life?', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '4.5'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 months after cross-over home use period', 'description': 'Two questions asking how the specific orthoses affected activities they enjoy and their quality of life. Each question is on a 5-point scale, with 1=much worse and 5=much better.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects that answered the patient-reported outcome questions after having completed home-use periods with both KAFO/SCO and C-Brace (at Visit 2). 75 subjects provided answers to these questions.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'KAFO/SCO, Then C-Brace', 'description': 'Home use of 3 months with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)\n\nKAFO/SCO: Current knee ankle foot orthosis that the subject was wearing at baseline\n\nCrossover immediately after first home-use period to being fit with C-Brace, receiving training, and starting 3-month home-use period as soon as the subject demonstrates he/she is able to use it safely.'}, {'id': 'FG001', 'title': 'C-Brace, Then KAFO/SCO', 'description': "Home use of 3 months with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.\n\nC-Brace: The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint.\n\nCrossover to wearing previous KAFO/SCO, receives training if necessary, wears KAFO/SCO for a 1-month washout period then starting 3-month KAFO/SCO home-use period."}], 'periods': [{'title': 'Fitting/Assessment Prior to Home Use 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of access to site during COVID', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Home Use 1 (3 Months)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Fitting/Assessment Prior to Home Use 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lack of access to site during COVID', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Personal problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Home Use 2 (3 Months)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Could not cope with KAFO after C-Brace', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Potential participants were pre-screened based on their medical and/or orthotic records. After signing a written informed consent, participants were screened for inclusion and exclusion criteria. The screening process comprised a thorough patient evaluation and a test with the functional C-Brace trial tool to check whether the potential study participant was able to initiate swing and utilize controlled knee flexion during weight bearing.', 'preAssignmentDetails': '149 subjects were enrolled, and 41 failed screening (27 due to BBS score above 44, 11 failed the C-Brace trial tool assessment, 1 had a contraindication for the C-Brace, 1 had a history of vertigo, and 1 was geographically inaccessible). In addition, another 6 subjects dropped out after screening, but prior to randomization. Reasons for these early dropouts were lack of time (2) and personal problems (1) resulting in 102 patients randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'KAFO/SCO, Then C-Brace', 'description': 'Home use of 3 months with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)\n\nKAFO/SCO: Current knee ankle foot orthosis that the subject was wearing at baseline\n\nCrossover immediately after first home-use period to being fit with C-Brace, receiving training, and starting 3-month home-use period as soon as the subject demonstrates he/she is able to use it safely.'}, {'id': 'BG001', 'title': 'C-Brace, Then KAFO/SCO', 'description': "Home use of 3 months with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.\n\nC-Brace: The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint.\n\nCrossover to wearing previous KAFO/SCO, receives training if necessary, wears KAFO/SCO for a 1-month washout period then starting 3-month KAFO/SCO home-use period."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '56.1', 'spread': '15.2', 'groupId': 'BG000'}, {'value': '55.4', 'spread': '12.4', 'groupId': 'BG001'}, {'value': '55.8', 'spread': '13.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Netherlands', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Austria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '77.5', 'spread': '15.8', 'groupId': 'BG000'}, {'value': '82.8', 'spread': '16.3', 'groupId': 'BG001'}, {'value': '80.1', 'spread': '16.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '170.1', 'spread': '11.3', 'groupId': 'BG000'}, {'value': '170.3', 'spread': '11.3', 'groupId': 'BG001'}, {'value': '170.2', 'spread': '11.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Work/employment status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Employed', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Retired', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'Unemployed', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Side/bilateral orthosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Right', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Left', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Bilateral', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Type of orthosis used before study and as control', 'classes': [{'title': 'Locked KAFO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}, {'title': 'Posterior-offset KAFO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}, {'title': 'SCO (electrical)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'SCO (mechanical)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'This includes bilateral patients, so the number of orthoses will exceed the total number of participants', 'unitOfMeasure': 'participants'}, {'title': 'Use of walking aids inside', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Did the participant use walking aids indoors?', 'unitOfMeasure': 'Participants', 'populationDescription': 'Missing data for one patient'}, {'title': 'Use of walking aids outside', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Did the participant use walking aids outdoors?', 'unitOfMeasure': 'Participants', 'populationDescription': 'Missing data for one patient'}], 'populationDescription': 'Intention to Treat Group'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-16', 'size': 1566261, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-12-14T11:57', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Prospective international multi-center, open-labeled randomized, controlled cross-over trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 149}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2022-08-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-15', 'studyFirstSubmitDate': '2019-04-05', 'resultsFirstSubmitDate': '2023-10-19', 'studyFirstSubmitQcDate': '2019-04-05', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-15', 'studyFirstPostDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Efficacy: Berg Balance Scale (BBS)', 'timeFrame': 'Baseline, 3 months after initial home use period, and 3 months after cross-over home use period', 'description': "The Berg Balance Scale is a 14-item scale designed to measure static and dynamic balance in adults in a clinical setting. The range in score for the BBS is 0 to 56, with higher scores indicating better balance. Points for each item are deducted if the time or distance requirements are not met, the patient's performance requires supervision, or the patient requires assistance from support or examiner."}], 'secondaryOutcomes': [{'measure': 'Activity-specific Balance Confidence (ABC) Scale', 'timeFrame': 'Baseline, 3 months after initial home use period, and 3 months after cross-over home use period', 'description': 'Assessment of patient-perceived balance confidence for 16 activities of daily living. For each activity, subjects rate their level of confidence in doing the activity without losing their balance or becoming unsteady on a scale from 0% to 100%, with 100% being the highest level of confidence. The total score for the ABC scale is an average of all activity scores.'}, {'measure': 'Dynamic Gait Index (DGI)', 'timeFrame': 'Baseline, 3 months after initial home use period, and 3 months after cross-over home use period', 'description': 'An 8-item test used to assess balance during walking tasks. It has a maximum score of 24 with each item being scored 0-3. A higher score indicates greater balance, and subjects lose a a point on all items for which an assistive device is needed.'}, {'measure': '6-minute Walk Test', 'timeFrame': 'Baseline, 3 months after initial home use period, and 3 months after cross-over home use period', 'description': 'Distance walked in 6 minutes over 12-meter back-and-forth pathway as a measure of functional exercise capacity.'}, {'measure': 'Stair Assessment Index (SAI) - Down', 'timeFrame': 'Baseline, 3 months after initial home use period, and 3 months after cross-over home use period', 'description': 'A 14-point ordinal scale (0 - 13) used to assess different gait patterns during descent of stairs. The range of total scores for the SAI is from 0 to 26, with a higher score indicating a more normative gait pattern and needing less assistance.'}, {'measure': 'Frequency of Falling', 'timeFrame': 'Baseline, 3 months after initial home use period, and 3 months after cross-over home use period', 'description': 'Frequency of falling by using C-Brace compared to KAFO/SCO as measured by the number of falls in 3-month period by recollection at baseline and recorded in a Falls Diary during home-use periods'}, {'measure': 'Fear of Falling', 'timeFrame': 'Baseline, 3 months after initial home use period, and 3 months after cross-over home use period', 'description': "Two questions on patients' fear of falling indoors and outdoors based on an 11-point scale (0 = no fear, 10 = max. fear). The total score will range from 0 to 20, with 20 being maximum fear of falling."}, {'measure': 'Probability of Falling More Than Once When Using C-Brace Compared to KAFO/SCO', 'timeFrame': '3 months after initial home use period, and 3 months after cross-over home use period', 'description': 'Proportion of subjects having reported falling more than once will be compared between KAFO and C-Brace home-use periods'}, {'measure': 'Reintegration to Normal Living (RNL) Index Questionnaire', 'timeFrame': 'Baseline, 3 months after initial home use period, and 3 months after cross-over home use period', 'description': '11 items measuring satisfaction regarding perceived physical functioning, and social and emotional life. Higher scores represent higher levels of participation. The range of the adjusted total score is 0 to 100.'}, {'measure': 'EQ-5D-5L', 'timeFrame': 'Baseline, 3 months after initial home use period, and 3 months after cross-over home use period', 'description': 'Measure of health status composed of 5 dimensions: mobility, ability to self-care, ability to undertake usual activities, pain and discomfort, anxiety and depression. Each dimension is rated on a 5-point scale indicating the level of perceived problems for each dimension (level 1 indicating no problems and level 5 indicating extreme problems). The raw score is then aggregated and normalized based on region to a 0 to 1 scale (where 0 represents maximum issues and 1 represents no problems).'}, {'measure': 'Work Limitations Questionnaires WLQ-25', 'timeFrame': 'Baseline, 3 months after initial home use period, and 3 months after cross-over home use period', 'description': '25-item questionnaire to evaluate at-work disability and productivity loss under four sub-scales: time demands, physical demands, mental/interpersonal demands, and output demands. Scale scores range from 0 (limited none of the time) to 100 (limited all of the time).'}, {'measure': 'Orthotics & Prosthetics User Survey (OPUS)', 'timeFrame': 'Baseline, 3 months after initial home use period, and 3 months after cross-over home use period', 'description': 'A self-report questionnaire designed to evaluate the outcome of orthotic and prosthetic services. Three of the five domains will be administered: lower extremity functional status (20 items, score ranges from 0 - 80, with high score being easier), health-related quality of life index (23 items, score ranges from 0 - 92, with higher score being better) and satisfaction with device (11 items, score ranges from 11 - 55, with higher score being more satisfaction) scales. The domains of upper limb functional measure and satisfaction with service are not applicable in this study.'}, {'measure': 'Medical Outcomes Study Short Form (SF-36)', 'timeFrame': 'Baseline, 3 months after initial home use period, and 3 months after cross-over home use period', 'description': '36-item scale constructed to survey health status and quality of life. It assesses eight health concept scales: physical functioning, role functioning/physical, role functioning/emotional, energy/fatigue, emotional well-being, social functioning, pain and general health. Each scale score ranges from 0 to 100 with 100 being the highest (better) score.'}, {'measure': 'Quebec User Evaluation on Satisfaction With Assistive Technology (QUEST)', 'timeFrame': 'Baseline, 3 months after initial home use period, and 3 months after cross-over home use period', 'description': '12-item instrument used to assess satisfaction with a specific assistive device. Each questions is rated on a 5-point scale, with 1=not satisfied at all and 5=very satisfied. The first 8 questions comprise the Device subscale and the last 4, the Services subscale. Each subscale and the total score are presented as averages ranging from 1 to 5, with higher scores representing greater satisfaction.'}, {'measure': 'Patient-Related Outcome Questions', 'timeFrame': '3 months after cross-over home use period', 'description': 'Two questions asking how the specific orthoses affected activities they enjoy and their quality of life. Each question is on a 5-point scale, with 1=much worse and 5=much better.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pareses, Lower Extremity']}, 'descriptionModule': {'briefSummary': 'Prospective, international, multi-center, open-labeled, randomized, controlled cross-over trial to evaluate effectiveness and benefits in patients with lower limb impairment in activities of daily living comparing the C-Brace microprocessor-controlled stance and swing orthosis to standard of care use of knee ankle foot orthosis/stance control orthoses', 'detailedDescription': 'After obtaining informed consent, patients will be screened. For subjects fulfilling inclusion/exclusion criteria, a first baseline assessment will be conducted. Within one to two days, a second set of baseline data will be collected for performance measures. Subjects will then be randomly assigned to be fitted with C-Brace or to continue wearing the current KAFO/SCO. After fitting, an accommodation period follows that will last up to 14 days prior to the initial home use. The first follow-up data collection will occur after three months of the initial home use period. Afterwards, the patients will cross over to KAFO/SCO or C-Brace, respectively. The participants who were fitted with C-Brace will cross over to KAFO/SCO and vice versa. Another accommodation phase will be offered for both C-Brace and KAFO/SCO wearers to ensure that subjects can properly use both devices before the cross-over home use period. The second follow-up data collection will occur after 3-months of the cross-over home use period. At the end of the study, the patients can choose to keep the C-Brace for up to 24 months until reimbursement or to return to their original KAFO/SCO.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has been tested with the Trial Tool (DTO) and demonstrated the potential to utilize the C-Brace successfully\n* Patient has a BBS score \\< 45\n* Lower limb functional impairment according to CE label wording\n* Prior active and compliant use of unilateral or bilateral KAFO or SCO in the past 3 months prior to enrollment in the study\n* Patient meets minimum physical requirements to be fitted with a C-Brace, such as muscle status, joint mobility, leg axis and proper control of the orthosis must be guaranteed.\n* The User must fulfill the physical and mental requirements for perceiving optical/acoustic signals and/or mechanical vibrations\n* The existing muscle strength of the hip extensors and flexors must permit the controlled swing-through of the limb (compensation using the hip is possible).\n* Patient´s commitment to use C-Brace 2 at least 1-2 hours per day 5 days per week-\n* Patient is ≥ 18 years old\n* Patient is willing and able to independently provide informed consent.\n* Person is willing to comply with study procedures\n\nExclusion Criteria:\n\n* Patient who is not able to follow the entire study visits or is unwilling/unable to follow the instructions\n* Patient was not able to use DTO\n* Patient who is not using an orthosis at least 1 to 2 hours/ day for 5 days per week\n* Patient with body weight \\> 125 kg (includes body weight and heaviest object (weight) carried)\n* Patient with Orthoprosthesis\n* Patient with flexion contracture in the knee and/or hip joint in excess of 10°\n* Patient with uncontrolled moderate to severe spasticity (relative contraindication moderate spasticity)\n* Leg length discrepancy in excess of 15 cm\n* Patient with unstable neurological or cardiovascular/pulmonary disease, cancer\n* Pregnancy\n* Patient using a C-Brace\n* Patient with known vertigo or with history of falls unrelated to orthosis use or unrelated to motor disability\n* Patient who has never been fitted an orthosis before\n* Patient is not able to answer the self-administered questionnaires independently; for patients with upper extremity impairment is it allowed to verbally answer the questions.\n* Patient participating already in a study during this study´s duration\n* Patient participated in earlier C-Brace studies'}, 'identificationModule': {'nctId': 'NCT03906656', 'briefTitle': 'Clinical Trial Comparing C-Brace to Knee Ankle Foot Orthosis (KAFO)/Stance Control Orthosis (SCO)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Otto Bock Healthcare Products GmbH'}, 'officialTitle': 'Multinational Randomized Controlled Cross-over Trial Comparing C -Brace to Conventional Knee Ankle Foot Orthoses With Respect to Balance, Fall Risk and Activities of Daily Living', 'orgStudyIdInfo': {'id': 'PS00120016A-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'KAFO/SCO', 'description': 'Home use of 3 months with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)', 'interventionNames': ['Device: KAFO/SCO']}, {'type': 'EXPERIMENTAL', 'label': 'C-Brace', 'description': 'Home use of 3 months with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.', 'interventionNames': ['Device: C-Brace']}], 'interventions': [{'name': 'C-Brace', 'type': 'DEVICE', 'otherNames': ['Microprocessor-controlled Stance and Swing Orthosis (MP-SSCO)'], 'description': "The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint.", 'armGroupLabels': ['C-Brace']}, {'name': 'KAFO/SCO', 'type': 'DEVICE', 'otherNames': ['Locked KAFO, Posterior offset KAFO, Stance Control Orthosis'], 'description': 'Current knee ankle foot orthosis that the subject was wearing at baseline', 'armGroupLabels': ['KAFO/SCO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34233', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Hanger Clinic', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '60657', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Scheck & Siress', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '77025', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Hanger Clinic', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98116', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Hanger Clinic', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Vienna', 'country': 'Austria', 'facility': 'Orthopädisches Spital Speising Speisingerstraße 109', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '10117', 'city': 'Berlin', 'state': 'Deutschland', 'country': 'Germany', 'facility': 'BeMoveD - Berlin Movement Diagnostics', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '56073', 'city': 'Koblenz', 'state': 'Rhineland-Palatinate', 'country': 'Germany', 'facility': 'Katholisches Klinikum Koblenz-Montabaur', 'geoPoint': {'lat': 50.35357, 'lon': 7.57883}}, {'zip': '01773', 'city': 'Altenberg', 'country': 'Germany', 'facility': 'Johannesbad Raupennest GmbH & Co. KG', 'geoPoint': {'lat': 50.76556, 'lon': 13.75334}}, {'zip': '37073', 'city': 'Göttingen', 'country': 'Germany', 'facility': 'Zentrum für Healthcare Technology der Privaten Hochschule Göttingen', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'zip': '21033', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'BG Klinikum Hamburg gGmbH Zentrum für Rehabilitationsmedizin', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '69118', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Universitätsklinikum Heidelberg, Zentrum für Orthopädie, Unfallchirurgie und Paraplegiologie', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '83278', 'city': 'Traunstein', 'country': 'Germany', 'facility': 'Pohlig GmbH', 'geoPoint': {'lat': 47.86825, 'lon': 12.64335}}, {'zip': '6432 CC', 'city': 'Hoensbroek', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'Adelante Kenniscentrum', 'geoPoint': {'lat': 50.92387, 'lon': 5.92528}}], 'overallOfficials': [{'name': 'Frank Braatz, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zentrum für Healthcare Technology der Privaten Hochschule Göttingen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Otto Bock Healthcare Products GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}