Clinical trial NCT02943915: The WISE Trial - Walking Improvement for SCI With Exoskeleton
Official title: The WISE Trial - Walking Improvement for SCI With Exoskeleton
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injuries, Spinal Cord
Keywords: Spinal Cord
Injury
Exoskeleton
Ekso
Rehabilitation
Lead sponsor: Ekso Bionics
Sponsor class: INDUSTRY
Collaborators: name: Burke Medical Research Institute
First posted: 2016-10-25
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.).

Eligibility criteria: 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

Primary outcomes:
measure: Change in Gait Speed From Baseline to 12 Weeks Using 10 Meter Walk Test (10MWT)
timeFrame: Baseline and 12 Weeks
Secondary outcomes:
measure: 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
timeFrame: Between baseline and 24 weeks
measure: Change in Distance Covered Over 6 Minutes From Baseline to 24 Weeks
timeFrame: Baseline-24 weeks
measure: Change in Time Required to Complete Timed Up and Go (TUG) Test From Baseline to 24 Week Follow up
timeFrame: Baseline and 24 weeks
measure: Number of Participants Who Experienced a Fall During Protocol
timeFrame: Throughout 24 weeks
measure: Change in Berg Balance Scale Score From Baseline to 24 Weeks
timeFrame: Baseline-24 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute at St. Joseph's Hospital and Medical Center
state: Arizona
city: Wallingford
country: United States
facility: Gaylord Hospital
state: Connecticut
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
city: Wheaton
country: United States
facility: Marianjoy Rehabilitation Hospital
state: Illinois
city: Baltimore
country: United States
facility: Kennedy Kruger Institute
state: Maryland
city: Detroit
country: United States
facility: Rehabilitation Institute of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Courage Kenny Research Center
state: Minnesota
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
city: White Plains
country: United States
facility: Burke Medical Research Institute
state: New York
city: Houston
country: United States
facility: TIRR Memorial Hermann Hospital
state: Texas
Study officials:
affiliation: Burke Medical Research Institute
name: Dylan Edwards, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stampacchia G, Rustici A, Bigazzi S, Gerini A, Tombini T, Mazzoleni S. Walking with a powered robotic exoskeleton: Subjective experience, spasticity and pain in spinal cord injured persons. NeuroRehabilitation. 2016 Jun 27;39(2):277-83. doi: 10.3233/NRE-161358.
citation: Gad PN, Gerasimenko YP, Zdunowski S, Sayenko D, Haakana P, Turner A, Lu D, Roy RR, Edgerton VR. Iron 'ElectriRx' man: Overground stepping in an exoskeleton combined with noninvasive spinal cord stimulation after paralysis. Annu Int Conf IEEE Eng Med Biol Soc. 2015 Aug;2015:1124-7. doi: 10.1109/EMBC.2015.7318563.
citation: Kozlowski AJ, Bryce TN, Dijkers MP. Time and Effort Required by Persons with Spinal Cord Injury to Learn to Use a Powered Exoskeleton for Assisted Walking. Top Spinal Cord Inj Rehabil. 2015 Spring;21(2):110-21. doi: 10.1310/sci2102-110. Epub 2015 Apr 12.
citation: Kressler J, Thomas CK, Field-Fote EC, Sanchez J, Widerstrom-Noga E, Cilien DC, Gant K, Ginnety K, Gonzalez H, Martinez A, Anderson KD, Nash MS. Understanding therapeutic benefits of overground bionic ambulation: exploratory case series in persons with chronic, complete spinal cord injury. Arch Phys Med Rehabil. 2014 Oct;95(10):1878-1887.e4. doi: 10.1016/j.apmr.2014.04.026. Epub 2014 May 17.
citation: Sale P, Russo EF, Russo M, Masiero S, Piccione F, Calabro RS, Filoni S. Effects on mobility training and de-adaptations in subjects with Spinal Cord Injury due to a Wearable Robot: a preliminary report. BMC Neurol. 2016 Jan 28;16:12. doi: 10.1186/s12883-016-0536-0.
citation: Kolakowsky-Hayner SA, Crew J, Moran S, Shah A. Safety and feasibility of using the EksoTM bionic exoskeleton to aid ambulation after spinal cord injury. Spine. 2013 doi.org/10.4172/2165-7939.S4-003
citation: Forrest GF, Hutchinson K, Lorenz DJ, Buehner JJ, Vanhiel LR, Sisto SA, Basso DM. Are the 10 meter and 6 minute walk tests redundant in patients with spinal cord injury? PLoS One. 2014 May 1;9(5):e94108. doi: 10.1371/journal.pone.0094108. eCollection 2014.