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.