Human Factors Validation Testing of the Wandercraft Personal Exoskeleton

Exclusion Criteria

• •Any neurological injury other than spinal cord injury (SCI), except where such injury does not result in physical disability
• •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.
• •Individual with history of osteoporotic fracture and / or pathology or treatment causing secondary osteoporosis.
• •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 as judged to be contraindicated by the site physician.
• •History of uncontrolled autonomic dysreflexia.
• •Presence of colostomy and/or urostomy.
• •Ventilator use at the time of exoskeleton use.
• •Presence of life supporting device (e.g., pacemaker).
• •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.
• •Individuals with functional and/or cognitive impairments that prevent them from effectively operating the device using a 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.
• •Patient under legal protection.
• •Inability to communicate with an assistant due to cognitive or 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.
• •Presence of life supporting device (e.g., pacemaker).
• •Concurrent participation in another interventional trial.