CSP #2003 - Exoskeleton Assisted-Walking in Persons With SCI: Impact on Quality of Life ((PEPSCI))

Inclusion Criteria:

1. Veterans or active duty military personnel who are at least 21 years of age;
2. Traumatic or non-traumatic SCI greater than or equal to 6 months duration of SCI;
3. Wheelchair-user for indoor and outdoor mobility;

4. Level and completeness of injury as follows:

   1. SCI levels between cervical six (C6) and thoracic three (T3) with an upper extremity motor function in each muscle group of 4 or greater;
   2. T4 and below with complete or incomplete SCI (ISNCSCI A to D);

5. Anthropometric compatibility with the device:

   1. Weight <220 lb. (100 kg),
   2. Thigh length between 14 and 19 in (36 and 48 cm),
   3. Shank length between 17 and 22 in (43 and 55 cm);
6. Able to hold the crutches in hands, with or without minor assistive modifications;
7. Able to have a companion who can attend approximately one-third of the training sessions who will assist them at home and in the community; and
8. Able to provide informed consent.

Exclusion Criteria:

1. Diagnosis of neurological injury other than SCI;
2. Progressive condition that would be expected to result in changing neurological status;
3. Severe concurrent medical disease, illness or condition judged to be contraindicated by the Site Physician;
4. Traumatic or high impact lower extremity fracture within the past 2 years;
5. Knee BMD < 0.60 gm/cm2;
6. Total hip BMD T-scores < -3.5;
7. Fragility, minimal trauma or low impact fracture of the lower extremity since spinal cord injury;
8. Untreatable severe spasticity judged to be contraindicated by the Site Physician;
9. Flexion contracture limited to > 0 at the hip and/or > 10 at the knee;
10. Limitations in ankle range of motion that cannot be adapted with a orthotic device;
11. Chronic anticoagulation therapy;
12. Able to ambulate 10 meters in 60 seconds (approximately 0.17 m/s) with or without a non-exoskeletal assistive device or physical assistance.
13. Untreated or uncontrolled hypertension (systolic blood pressure >140 mmHg; diastolic blood pressure >90 mmHg);
14. Unresolved orthostatic hypotension (systolic blood pressure <90 mmHg; diastolic blood pressure <60 mmHg) as judged to be contraindicated by the Site Physician;
15. Current pressure ulcer of the arms, trunk, pelvic area, or lower extremities;
16. Psychopathology documentation in the medical record or history of that may conflict with study objectives; and/or
17. Pregnancy or women who plan to become pregnant during the study period.