Safety and Feasibility of TWIICE Rise
Spinal Cord Injuries, Gait Disorders, Neurologic
About this trial
This is an interventional other trial for Spinal Cord Injuries focused on measuring Spinal Cord Injury, Exoskeleton, Robotics, Gait Rehabilitation, Lower-limb, Neurorehabilitation, Paraplegia, Walking, Assistive technology, Usability, Feasibility, Home use, Community use
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: History of severe neurological injuries other than spinal cord injury (e.g., Multiple Sclerosis, Cerebral Palsy, Amyotrophic Lateral Sclerosis, Traumatic Brain Injury, Stroke) Ability to walk 10 meters without physical assistance of a person Severe concurrent medical disease, illness, or condition 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 Individuals with a pacemaker, defibrillator, drug delivery pump, or other electrical devices if malfunctions could lead to serious adverse events. Deep vein thromboses in lower extremities of less than 6 months duration. Untreated sever hypertension (systolic blood pressure >180 mmHg, diastolic blood pressure >120 mmHg) Unstable spine or unhealed limbs History of lower extremities or pelvic fragility fractures within the last two years 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 Current pressure ulcer of the arms, trunk, pelvic area, or lower extremities Psychiatric or cognitive conditions that may interfere with the trial. Pregnancy or women who plan to become pregnant during the study period, and lactating women. Patient is currently involved in any other interventional study. Other severe illness that the study physician considers in his/her clinical judgment to be exclusionary.
Sites / Locations
- Swiss Paraplegic Centre NottwilRecruiting
Arms of the Study
Arm 1
Experimental
Exoskeleton assisted ambulation
Phase 1: Five participants will undergo a training programme with the TWIICE Rise 0.0 two times a week for up to 6 weeks for a total of 6 sessions. Phase 2: Ten participants will undergo a training programme with the TWIICE Rise 1.0 two times a week for up to 20 weeks for a total of 24 sessions.