The WISE Trial - Walking Improvement for SCI With Exoskeleton (WISE)

• ClinicalTrials.gov Identifier: NCT02943915
• Recruitment Status: Completed
• First Posted: October 25, 2016
• Last Update Posted: September 11, 2019
• Sponsor: Ekso Bionics
• Collaborator: Burke Medical Research Institute
• Information provided by (Responsible Party): Ekso Bionics

Study Description

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

Condition or disease	Intervention/treatment	Phase
Injuries, Spinal Cord	Device: Ekso GT Rehabilitation Therapy; Device: Body Weight Supported (BWS) Treadmill Training	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The WISE Trial - Walking Improvement for SCI With Exoskeleton
• Study Start Date: September 2016
• Actual Primary Completion Date: September 10, 2019
• Actual Study Completion Date: September 10, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	Device: Ekso GT Rehabilitation Therapy; Walking Improvement for Spinal Cord Injuries with Exoskeleton; Other Name: Exoskeleton
Active Comparator: 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	Device: Body Weight Supported (BWS) Treadmill Training; Standard gait training using BWS PT and overground training; Other Name: Conventional Therapy
No Intervention: Group 3: Passive controls; Participants in this group continue with normal daily activities over 12 weeks.

Outcome Measures

Primary Outcome Measures :

1. 10 Meter Walk Test (10MWT) [ Time Frame: Baseline and 12 Weeks ]
   The mean increase in gait speed demonstrated during the 10MWT after 12 weeks of training and compared between groups.

Secondary Outcome Measures :

1. 10 Meter Walk Test (10MWT) [ Time Frame: Baseline and evaluations week 6,12, 24 ]
   10MWT: Number of participants who achieve the Minimal Clinically Important Difference (MCID) of 0.15 m/s 21 during the 10MWT. Number of participants who transition from exercise or household ambulation (defined as a walking speed of < 0.44 meters/second) to limited community or full community ambulation (> 0.44 meter/second) during the 10MWT. Time point of recovery at which participants reach the MCID and/or community ambulation speeds of > 0.44 meters/second.
2. International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Exam - Full Exam for Classification [ Time Frame: Baseline and week 12 ]
   Number of participants who convert from American Spinal Cord Injury Association (AIS) C to AIS D.
3. International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Exam - Full Exam for Scoring [ Time Frame: Baseline and week 12 ]
   Motor and sensory scores
4. Participant Quality of Life [ Time Frame: Baseline and evaluations week 6, 12, 24 ]
   International SCI Quality of Life Basic Data Set. Depression scores using the Epidemiological Studies Depression Scale (CES-D 10).
5. Numeric Pain Rating Scale [ Time Frame: Weeks 1-12 ]
   Numeric Pain Rating Scale for self-reported neuropathic pain upon resting and during gait training.
6. Therapist Outcomes [ Time Frame: Weeks 1-12 ]
   Number of therapists/staff required for each active group as well as set-up/donning time for cost effectiveness of the two active therapies.
7. 6 Minute Walk Test (6MWT) [ Time Frame: Baseline, Evaluations week 6, 12, and 24 ]
   Measurement of endurance, level of assistance and assistive devices needed and distance walked
8. Timed Up and Go (TUG) [ Time Frame: Baseline, Evaluations week 6, 12, and 24 ]
   Test of basic mobility skills. Balance during sit-to-stand, walking, turning, and stand-to-sit.
9. Walking Index for Spinal Cord Injury II (WISCI-II) [ Time Frame: Baseline, Evaluations week 6, 12, and 24 ]
   Measurement of the ability of an individual to complete a locomotor task in a standardized environment. Score for need of assistive devices.
10. Spinal Cord Injury Functional Ambulatory Index (SCI-FAI) [ Time Frame: Baseline, Evaluations week 6, 12, and 24 ]
    Quality assessment of gait pattern
11. Spinal Cord Independence Measure (SCIM-III, Mobility subscale) [ Time Frame: Baseline, Evaluations week 6, 12, and 24 ]
    Mobility subscale for ability to perform transfers and walking different distances.
12. Body Mass Index (BMI) [ Time Frame: Baseline, Evaluations week 6, 12, and 24 ]
    General health measure.
13. Upper and Lower Extremity Muscle Strength [ Time Frame: Baseline, Evaluations week 6 and 24 ]
    As measured by physical therapist for muscle strength.
14. Spinal Cord Assessment Tool for Spastic Reflexes (SCATS) Modified Ashworth Scale [ Time Frame: Baseline, Evaluations week 6, 12, and 24 ]
    Spasticity measurement.
15. Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET) [ Time Frame: Baseline, Evaluations week 6, 12, 24 ]
    Participant reported spasticity measurement.
16. Numeric Rating of Spasticity [ Time Frame: Baseline and weekly assessments for 12 weeks ]
    Participant reported spasticity measurement.
17. Heart Rate [ Time Frame: Baseline, Weekly training sessions 1 - 12, Evaluations week 6, 12 and 24 ]
    Physiological outcomes: heart rate
18. Participant Borg Rating of Perceived Exertion Scale (Borg) [ Time Frame: Baseline and weekly assessments for 12 weeks, Evaluations week 6, 12 and 24 ]
    Self-reported perceived exertion.
19. Modified International SCI Bowel Function Basic Data Set [ Time Frame: Baseline, Evaluations week 6, 12 and 24 ]
    Participant assessment of bowel function
20. Modified International SCI Lower Urinary Tract Basic Data Set [ Time Frame: Baseline, Evaluations week 6, 12 and 24 ]
    Participant lower urinary tract assessment and incidence of urinary track infections.
21. Incidence of Pressure Ulcers [ Time Frame: Baseline, each training session 1 through 36. ]
    Skin integrity check.
22. Incidence of Falls [ Time Frame: Each training session 1 through 36, Evaluations week 6, 12 and 24 ]
    Assessed at each visit via participant report.
23. Incidence of Hospitalization and/or Unexpected Physician Visits [ Time Frame: Each training session 1 through 36, Evaluations week 6, 12 and 24 ]
    Assessed at each visit via participant report.
24. Therapist Borg Rating of Perceived Exertion Scale (Borg) [ Time Frame: Weeks 1 through 12 ]
    Self-reported perceived exertion.
25. Therapist National Aeronautics and Space Administration (NASA) Task Load Index [ Time Frame: Weeks 1 through 12 ]
    Self-reported work load assessment.
26. Participant National Aeronautics and Space Administration (NASA) Task Load Index [ Time Frame: Weeks 1 through 12 ]
    Self-reported work load assessment.
27. Video Assessment of Physical Therapist Posture [ Time Frame: Week 1 and Week 12 ]
    Independent assessment of shoulder, neck, and trunk posture.
28. Therapist Report of Pain and/or Injury [ Time Frame: Up to Week 12 ]
    Therapist self-reported questionnaire.
29. Blood Pressure [ Time Frame: Baseline, Evaluations week 6, 12 and 24 ]
    Physiological outcomes: blood pressure
30. Gait Quality [ Time Frame: Baseline, Evaluations week 6, 12 and 24 ]
    GAITRite for temporospatial gait parameters and symmetry
31. Berg Balance Scale [ Time Frame: Baseline, Evaluations week 6, 12 and 24 ]
    Measurement of static and dynamic sitting and standing balance

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Arizona

Barrow Neurological Institute at St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States, 85013

United States, Connecticut

Gaylord Hospital

Wallingford, Connecticut, United States, 06492

United States, Illinois

Shirley Ryan AbilityLab

Chicago, Illinois, United States, 60611

Marianjoy Rehabilitation Hospital

Wheaton, Illinois, United States, 60187

United States, Maryland

Kennedy Kruger Institute

Baltimore, Maryland, United States, 21211

United States, Michigan

Rehabilitation Institute of Michigan

Detroit, Michigan, United States, 48201

United States, Minnesota

Courage Kenny Research Center

Minneapolis, Minnesota, United States, 55407

United States, New Jersey

Kessler Foundation

West Orange, New Jersey, United States, 07052

United States, New York

Burke Medical Research Institute

White Plains, New York, United States, 10605

United States, Texas

TIRR Memorial Hermann Hospital

Houston, Texas, United States, 77030

Sponsors and Collaborators

Ekso Bionics

Burke Medical Research Institute

Investigators

• Principal Investigator: Dylan Edwards, PhD; Burke Medical Research Institute

More Information

Publications:

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.

• Responsible Party: Ekso Bionics
• ClinicalTrials.gov Identifier: NCT02943915
• Other Study ID Numbers: 105333
• First Posted: October 25, 2016
• Last Update Posted: September 11, 2019
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: Undecided

Keywords provided by Ekso Bionics:

Spinal Cord; Injury; Exoskeleton; Ekso; Rehabilitation

Additional relevant MeSH terms:

Spinal Cord Injuries; Spinal Injuries; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Back Injuries