Self-balancing Personal Exoskeleton for SCI (WINY)

SCI user inclusion Criteria:

* Any gender, age 18 years or older;
* Motor complete or incomplete SCI with lesions at or above T6;
* ≥ 6 months post SCI;
* Able and willing to attend 9 to 10 visits1 to the center, including sessions of training and assessments of one-to-three hours duration;
* Able to read, understand, and provide informed consent;
* Living in the US and speaks English.

SCI user 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;

Companion inclusion Criteria:

* Any gender, age 18 years or older;
* Willingness to attend 9 to 10 visits to the center, including sessions of training and assessments of one-to-three hours duration with the SCI user;
* Able to read, understand and provide informed consent;
* Living in the US and speaks English.

Companion exclusion Criteria:

* 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.