ExoAtlet II For SCI Patients (EXOATLET2SCI)

This is an interventional treatment trial for Spinal Cord Injuries Read More

Inclusion Criteria:

1. 18 Years of age or older in general good health
2. Weight, no more than 220lbs (100kg)
3. Skin must be healthy where it touches the ExoAtlet 2.0
4. Able to stand using a device such as a standing frame
5. Have enough strength in your hands and shoulders to support yourself standing and walking using crutches or a walker
6. Have good control of upper body
7. Determined to have enough bone health to walk full weight bearing without risk of fracture. Meeting of this condition is at the discretion of your personal MD
8. Passive range of motion (PROM) at shoulders, trunk, upper extremities and lower extremities within functional limits for safe gait and use of appropriate assistive device/stability aid
9. Hip width no greater than 18" (46 cm) measured when sitting.
10. Femur length between 37 cm and 49 cm measured between mid patellar tendon and the floor.
11. In general, good health and able to tolerate moderate levels of activity.
12. Blood pressure and heart rate within established guidelines for locomotive training: At rest; Systolic 150 or less Diastolic 90 or less and Heart rate 100 or less Exercise; Systolic 180 or less, Diastolic 105 or less and Heart Rate 145 or less

Exclusion Criteria:

1. Spinal cord injury level higher than T4 or C7 ASIA D
2. Severe muscle stiffness/tightness
3. Significant spasticity (Modified Ashworth Scale score of 3 or above)
4. Trunk or lower extremity pressure ulcer
5. Open Wounds/tissue hypersensitivity
6. Unstable spine, un-healed limbs, or fractures
7. Severe sensitivity to touch
8. Presence of bone in soft tissue where bone normally does not exist (heterotopic ossification), limiting range of motion in the hip or knee joints
9. Joint instability, dislocation, moderate to severe hip dysplasia
10. Significant scoliosis (>40 degrees)
11. Hardware, implant, or any external device impeding with safe fitting or use of ExoAtlet 2.0
12. Femoral or tibial rotation deformity (>15 degrees)
13. Significant flexion contractures limited to 35º at the hip and 20º at the knee
14. Uncontrolled seizures, musculoskeletal injury, fracture or lower-limb surgery in past year.
15. Known history of pulmonary disease limiting exercise tolerance or history of cardiac disease
16. Psychopathology, or other condition that the physician or investigator, in his or her clinical judgment, considers to be exclusionary to safely use an exoskeleton.
17. Severe concurrent medical diseases, illness, systemic or peripheral infection
18. Dizziness or headache with standing
19. History of autonomic dysreflexia
20. Orthostatic Hypotension: Decrease in Systolic BP > 20, Diastolic BP > 10 upon standing from a seated position.
21. Pregnant or lactating females