Safety and Feasibility of TWIICE Rise - Phase 2

Ki vehet részt

• Informed Consent signed by the subject
• Traumatic and non-traumatic SCI
• Motor incomplete SCI with Neurological Level of Injury (NLI) C5-L5, or Motor Complete SCI with NLI T1-L5 as determined by the ISNCSCI
• Male and non-pregnant, non-lactating female aged 18 to 70 years old
• At least 6 months after injury
• Able to stand or maintain upright position with a standing device (e.g., 'Easy stand') for at least ten minutes without clinical symptoms of orthostatic hypotension
• Able to use crutches
• Able to sit with knees and hips >= 90° flexion
• Phase 1: Height of 160 to 180 cm, Phase 2: Height of 160 to 190 cm
• Phase 1: Weight of <80 kg, Phase 2: Weight of <100 kg

Ki nem vehet részt

• Severe concurrent medical disease, illness, or condition
• Individuals with a pacemaker, defibrillator, drug delivery pump, or other electrical devices if malfunctions could lead to serious adverse events
• History of severe neurological injuries other than spinal cord injury (e.g., Multiple Sclerosis, Cerebral Palsy, Amyotrophic Lateral Sclerosis, Traumatic Brain Injury, Stroke)
• Systemic or peripheral infection influencing wearing an exoskeleton
• Diagnosis of coronary artery disease that precludes moderate to intense exercise
• A medical diagnosis in the patient chart of atherosclerosis, congestive heart failure, or history of myocardial infarction
• Untreated sever hypertension (systolic blood pressure >180 mmHg, diastolic blood pressure >120 mmHg)
• History of lower extremities or pelvic fragility fractures within the last two years
• Current pressure ulcer of the arms, trunk, pelvic area, or lower extremities
• Psychiatric or cognitive conditions that may interfere with the trial
• Other severe illness that the study physician considers in his/her clinical judgment to be exclusionary
• Ability to walk 10 meters without physical assistance of a person
• Deep vein thromboses in lower extremities of less than 6 months duration
• Unstable spine or unhealed limbs
• Heterotopic ossification that impairs joint mobility
• Significant contractures defined as flexion contracture limited to 20 the hip and knee
• Severe spasticity (Modified Ashworth grade 4) or uncontrolled clonus
• Diagnosis of severe osteoporosis/penia: Dual Energy X-ray Absorptiometry (DXA) results indicating a t-score below -3.5 at the femoral neck or the total proximal femur bone, and knee bone mineral density (BMD) < 0.60 gm/cm2
• Pregnancy or women who plan to become pregnant during the study period, and lactating women
• Patient is currently involved in any other interventional study