Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
Eligibility 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.
- * 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).
Ages Eligible for Study
18 Years to
Sexes Eligible for Study
ALL
Accepts Healthy Volunteers
Yes