The WISE Trial - Walking Improvement for SCI With Exoskeleton

Community dwelling iSCI participants may improve clinical gait function by engaging in a gait
training regimen, where robotic exoskeletons can readily deliver a precise dose and
simultaneously reduce the physical stress imposed on therapists using conventional manually
assisted stepping practice. Exoskeleton training is predicted to improve function in
participants receiving usual care, but not superior to intensity-matched manual training. The
rationale to implement exoskeleton robotics as preference in gait training is based on
precision dosing, over-ground training, and reduced therapist burden for high repetition
training.

The investigators aim to demonstrate that Ekso exoskeleton training can significantly improve
gait speed in stable chronic, community-dwelling incomplete SCI (iSCI) participants. The
objectives of this study are the following:

A. Primary Objective:

To demonstrate that a 12 week robotic gait training regimen can lead to a clinically
meaningful improvement in independent gait speed on the 10 Meter Walk Test (10MWT) in
community dwelling participants with chronic iSCI.

B. Secondary Objectives:

1. To examine the economic factors such as number of physical therapists/staff required
during training.

2. To analyze the physical burden on therapists assisting and supervising during training.

3. To study the influence of factors that may modify the gait recovery in the chronic
incomplete SCI population (demographic, clinical, functional, psychological, balance,
etc.).

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