Self-balancing Personal Exoskeleton for SCI (Site 2)

Exclusion Criteria

• •Diagnosis of neurological injury other than SCI;
• •Progressive condition that would be expected to result in changing neurological status;
• •Severe concurrent medical disease, illness or condition judged to be contraindicated by the site physician;
• •Unhealed or unstable traumatic or high impact lower extremity fracture of any duration that is, in the clinical judgement of the study physician, exclusionary for standing and walking;
• •Knee (proximal tibia and/or distal femur) BMD \<0.60 gm/cm2;
• •Total hip BMD T-scores \< -3.5;
• •Fragility, minimal trauma, or low impact fracture of the lower extremity since SCI;
• •Untreatable severe spasticity judged to be contraindicated by the site physician;
• •Untreated/uncontrolled hypertension, as judged to be contraindicated by the site physician;
• •Unresolved orthostatic hypotension (change from baseline seated BP to a fall in 20mmHg SBP and/or fall in 10mmHG DBP and symptoms when standing), or as judged to be contraindicated by the site physician;
• •Open or unhealed skin pressure sores, abrasions, or bruises at any of the contact points of the exoskeleton;
• •Morphological contraindications to the use of the device;
• •Uncorrectable leg length discrepancy over 2 cm (about 0.79 in) when using additional correction tools;
• •Unable to effectively operate the device with a hand-control interface, due to functional and/or cognitive impairment, evaluated based on the ability to manipulate the joystick in all direction, press and identify buttons on the hand control interface.
• •Improper fitting in the device;
• •Psychopathology documentation in the medical record that may conflict with study objectives;
• •Pregnancy or women who plan to become pregnant during the study period;
• •Concurrent participation in another interventional trial;
• •History of uncontrolled autonomic dysreflexia;
• •Presence colostomy and/or urostomy;
• •Ventilator use at the time of the exoskeleton use;
• •Insufficient strength and performance capability (the ability to transfer into/out of the device or perform other training tasks with assistance).
• •Inability to communicate with an assistant due to cognitive and language disorders;
• •Any disease, concomitant injury, or condition that interferes with the performance or interpretation of the protocol- specified assessments;
• •Insufficient strength and performance capability, evidenced by the ability to hold and retain the device in case of unbalance/fall;
• •Insufficient availability to complete the study;
• •Concurrent participation in another interventional trial.