The WISE Trial - Walking Improvement for SCI With Exoskeleton
NCT ID: NCT02943915
Last Updated: 2023-10-31
Study Results
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View full resultsBasic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
2016-09-30
2019-09-10
Brief Summary
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Detailed Description
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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.).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group 1: 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
Ekso GT Rehabilitation Therapy
Walking Improvement for Spinal Cord Injuries with Exoskeleton
Group 2: Active controls - BWSTT Therapy
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
Body Weight Supported (BWS) Treadmill Training
Standard gait training using BWS PT and overground training
Group 3: Passive controls
Participants in this group continue with normal daily activities over 12 weeks.
No interventions assigned to this group
Interventions
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Ekso GT Rehabilitation Therapy
Walking Improvement for Spinal Cord Injuries with Exoskeleton
Body Weight Supported (BWS) Treadmill Training
Standard gait training using BWS PT and overground training
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Burke Medical Research Institute
OTHER
Ekso Bionics
INDUSTRY
Responsible Party
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Principal Investigators
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Dylan Edwards, PhD
Role: PRINCIPAL_INVESTIGATOR
Burke Medical Research Institute
Locations
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Barrow Neurological Institute at St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Gaylord Hospital
Wallingford, Connecticut, United States
Shirley Ryan AbilityLab
Chicago, Illinois, United States
Marianjoy Rehabilitation Hospital
Wheaton, Illinois, United States
Kennedy Kruger Institute
Baltimore, Maryland, United States
Rehabilitation Institute of Michigan
Detroit, Michigan, United States
Courage Kenny Research Center
Minneapolis, Minnesota, United States
Kessler Foundation
West Orange, New Jersey, United States
Burke Medical Research Institute
White Plains, New York, United States
TIRR Memorial Hermann Hospital
Houston, Texas, United States
Countries
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References
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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.
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.
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.
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.
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.
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
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.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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105333
Identifier Type: -
Identifier Source: org_study_id
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