The WISE Trial - Walking Improvement for SCI With Exoskeleton

Not Applicable

Completed

• Conditions: Injuries, Spinal Cord
• Interventions: Device: Body Weight Supported (BWS) Treadmill Training; Device: Ekso GT Rehabilitation Therapy

• Registration Number: NCT02943915
• Lead Sponsor: Ekso Bionics

Brief Summary

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

Detailed 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.).

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-27
• Study First Submitted QC: 2016-10-21
• Study First Posted: 2016-10-25
• Primary Completion: 2019-09-10
• Study Completion: 2019-09-10
• Results First Submitted: 2023-03-29
• Status Verified: 2023-10
• Results First Submitted QC: 2023-10-27
• Last Update Submitted: 2023-10-27
• Results First Posted: 2023-10-31
• Last Update Posted: 2023-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: Active controls - BWSTT Therapy	Body Weight Supported (BWS) Treadmill Training	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
Group 1: Ekso GT Rehabilitation Therapy	Ekso GT Rehabilitation Therapy	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

Primary Outcome Measures

Name	Time	Method
Change in Gait Speed From Baseline to 12 Weeks Using 10 Meter Walk Test (10MWT)	Baseline and 12 Weeks	The mean change in gait speed demonstrated during the 10MWT after 12 weeks of training and compared between groups. Positive values indicate improvement in gait speed (faster) from baseline to 12 weeks. Negative values indicate a reduction in gait speed (slower) from baseline to 12 weeks.

Secondary Outcome Measures

Name	Time	Method
Change in Time Required to Complete Timed Up and Go (TUG) Test From Baseline to 24 Week Follow up	Baseline and 24 weeks	Examined balance and walking in participants at baseline and follow up at 24 weeks. Positive values indicate an improvement of time (less time) required to complete task at 24 week follow up versus at baseline. Negative values indicate a decline, more time required to complete task at follow up versus baseline.
Number of Participants Who Experienced a Fall During Protocol	Throughout 24 weeks	At each training session, assessed if participant had experienced any falls. Count is number of participants who reported that yes, they did experience a fall.
Number of Participants Who Met the Minimal Clinically Important Difference of 0.15m/s in Gait Speed Per 10 Meter Walk Test (10MWT) From Baseline to 24 Weeks	Between baseline and 24 weeks	Number of participants who achieve the Minimal Clinically Important Difference (MCID) of 0.15 m/s during the 10MWT when comparing between baseline gait speed and gait speed at 24 weeks.
Change in Distance Covered Over 6 Minutes From Baseline to 24 Weeks	Baseline-24 weeks	6 minute walk test (6MWT) completed at baseline and 24 weeks. Change assessed. Positive values indicate an increase in distance was able to be walked at 24 weeks versus at baseline. Negative values indicate a decrease in distance was walked at 24 weeks versus at baseline.
Change in Berg Balance Scale Score From Baseline to 24 Weeks	Baseline-24 weeks	Measurement of static and dynamic sitting and standing balance completed at baseline and at 24 weeks. Berg balance scale is a 14 item test with each item scored from 0-4. Possible scores range from 0-56. Higher scores indicate a lower risk of falls and better balance. Positive numbers indicate an improvement in Berg balance scale (scored out of 56), meaning that the participant scored higher at 24 weeks than at baseline. Negative values indicate a decline in performance of the Berg balance scale (scored out of 56), meaning that the participant scored lower at 24 weeks than at baseline.

Trial Locations

Locations (10)

Shirley Ryan AbilityLab; 🇺🇸 Chicago, Illinois, United States

Kennedy Kruger Institute; 🇺🇸 Baltimore, Maryland, United States

Barrow Neurological Institute at St. Joseph's Hospital and Medical Center; 🇺🇸 Phoenix, Arizona, United States

Rehabilitation Institute of Michigan; 🇺🇸 Detroit, Michigan, United States

Courage Kenny Research Center; 🇺🇸 Minneapolis, Minnesota, United States

Gaylord Hospital; 🇺🇸 Wallingford, Connecticut, United States

Kessler Foundation; 🇺🇸 West Orange, New Jersey, United States

Marianjoy Rehabilitation Hospital; 🇺🇸 Wheaton, Illinois, United States

Burke Medical Research Institute; 🇺🇸 White Plains, New York, United States

TIRR Memorial Hermann Hospital; 🇺🇸 Houston, Texas, United States