The WISE Trial - Walking Improvement for SCI With Exoskeleton

Ekso Bionics

Status: Completed

Conditions: Injuries, Spinal Cord

Treatments: Device: Ekso GT Rehabilitation Therapy; Device: Body Weight Supported (BWS) Treadmill Training

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02943915

105333

Details and patient eligibility

About

A randomized, controlled trial comparing exoskeleton gait training with standard gait training or no gait training in community-dwelling participants with chronic incomplete spinal cord injury

Full description

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.).

Enrollment: 45 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 3 patient groups

Group 1: Ekso GT Rehabilitation Therapy

Experimental group

Description:

Participants in this group receive Ekso GT (gait training) PT therapy intervention 3 times per week for 12 weeks (36 sessions). Intervention: Ekso GT Rehabilitation therapy

Treatment:

Device: Ekso GT Rehabilitation Therapy

Group 2: Active controls - BWSTT Therapy

Active Comparator group

Description:

Participants in this group receive a matched number of sessions of standard gait training using body-weight supported treadmill training and overground training. Intervention: Body Weight Supported Treadmill Training

Treatment:

Device: Body Weight Supported (BWS) Treadmill Training

Group 3: Passive controls

No Intervention group

Description:

Participants in this group continue with normal daily activities over 12 weeks.