The WISE Trial - Walking Improvement for SCI With Exoskeleton (WISE)

This is an interventional treatment trial for Injuries, Spinal Cord focused on measuring Spinal Cord, Injury, Exoskeleton, Ekso, Rehabilitation Read More

Inclusion Criteria:

1. Motor incomplete paraplegia or tetraplegia
2. Neurological level of injury (NLI) C1- approximately T10 (inclusive, for upper motor neuron injuries only), as determined by the International Standards for Neurological Classification of SCI (ISNCSCI)
3. Sufficient diaphragmatic strength such that respiration is not compromised with exercise.
4. Sufficient upper extremity strength to use a front wheeled walker either by manual muscle testing (minimum triceps strength bilaterally of 3/5, shoulder abduction/adduction and flexion/extension 4/5)
5. AIS-C SCI & AIS-D SCI, as determined by the International Standards for Neurological Classification of SCI (ISNCSCI)
6. Ambulates at <0.44 meters/second with or without physical assistance and assistance device
7. WISCI ≥ 1
8. 18 - 75 yrs, inclusive
9. No current or history of other neurological conditions
10. Screened and cleared by a physician
11. Involved in standing program or must be able to tolerate at least 15 min upright
12. Weigh 220 pounds (100kg) or less
13. Be able to fit into the Ekso device
14. Approximately between 5'0" and 6'4" tall
15. Standing hip width of approximately 18" or less
16. Have near normal range of motion in hips, knees and ankles

Exclusion Criteria:

1. AIS-A SCI or AIS-B SCI
2. Lower motor neuron injuries, as shown by absent reflexes during bilateral quadriceps and Achilles tendon taps
3. < 3 months since previous intensive gait training regimen
4. Already walking at self-selected ambulation speeds of at least 0.44 meter/second with or without assistance
5. Currently involved in another intervention study
6. Concurrent neurological disease
7. Hip flexion contracture greater than ~17°
8. Knee flexion contracture greater than 12°
9. Unable to achieve neutral ankle dorsiflexion with passive stretch (neutral with max 12° knee flexion)

10. Leg length discrepancy

    1. Greater than 0.5" for upper leg
    2. Greater than 0.75" for lower leg
11. Spinal instability
12. Unresolved deep vein thrombosis
13. Uncontrolled autonomic dysreflexia
14. Severe muscular or skeletal pain
15. Spasticity that prevents joint motion (severe stiffness or rigidity,) where both legs have a Modified Ashworth Score (MAS) score of 3 or higher for half or more of their proximal lower extremity muscles; proximal muscles include hip flexors/extensors/adductors and knee flexors/extensors.
16. Open skin ulcerations on buttocks or other body surfaces in contact with exoskeleton or harness
17. Pregnancy
18. Cognitive impairments - unable to follow 2 steps commands and communicate for pain or to stop session
19. Shoulder extension Range of Motion (ROM) < 50° excludes crutches during sit to stand or vice versa. (Walking with crutches permitted.)
20. Participant requires the assistance of more than one therapist to transfer safely.
21. Uncontrolled or severe orthostatic hypotension that limits standing tolerance; defined as sustained, symptomatic drops in systolic and diastolic blood pressure when moving from sitting to standing
22. Active heterotrophic ossification (HO), hip dysplasia or hip/knee axis abnormalities
23. Colostomy
24. History of long bone fractures since the SCI, secondary to osteoporosis
25. Unable to sustain current medication regimen
26. Any reason the physician may deem as harmful to the participant to enroll or continue in the study