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

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ClinicalTrials.gov Identifier: NCT02943915
Recruitment Status : Recruiting
First Posted : October 25, 2016
Last Update Posted : August 9, 2018
Sponsor:
Collaborator:
Burke Medical Research Institute
Information provided by (Responsible Party):
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

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 164 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
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

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.



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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02943915


Locations
United States, Arizona
Barrow Neurological Institute at St. Joseph's Hospital and Medical Center Active, not recruiting
Phoenix, Arizona, United States, 85013
United States, Connecticut
Gaylord Hospital Active, not recruiting
Wallingford, Connecticut, United States, 06492
United States, Illinois
Shirley Ryan AbilityLab Recruiting
Chicago, Illinois, United States, 60611
Contact: Sara Prokup, PT, DPT    312-238-1355    sprokup@ricres.org   
Principal Investigator: Arun Jayaraman, PT, PhD         
Marianjoy Rehabilitation Hospital Active, not recruiting
Wheaton, Illinois, United States, 60187
United States, Maryland
Kennedy Kruger Institute Recruiting
Baltimore, Maryland, United States, 21211
Contact: Shannon M. Inches    443-923-9235    Inches@kennedykrieger.org   
Contact: Rebecca Martin, OTR/L,OTD    443-923-7972    Martinre@kennedykrieger.org   
Sub-Investigator: Rebecca Martin, OTR/L,OTD         
Principal Investigator: Cristina Sadowsky, MD         
United States, Michigan
Rehabilitation Institute of Michigan Active, not recruiting
Detroit, Michigan, United States, 48201
United States, Minnesota
Courage Kenny Research Center Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Margaret Weightman, PT, PhD    612-863-6525    margaret.weightman@allina.com   
Contact: Stacey Rabusch, CCRC    612-863-0882    Stacey.Rabusch@allina.com   
Principal Investigator: Margaret Weightman, PT, PhD         
United States, New Jersey
Kessler Foundation Not yet recruiting
West Orange, New Jersey, United States, 07052
Contact: Leighann Martinez       LMartinez@kesslerfoundation.org   
Contact: Gail Forrest, Ph.D    973-324-3518    gforrest@kesslerfoundation.org   
Principal Investigator: Gail Forrest, Ph.D         
United States, New York
Burke Medical Research Institute Active, not recruiting
White Plains, New York, United States, 10605
United States, Texas
TIRR Memorial Hermann Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Ruta Paranjape, MS, CCRP    713-799-6976    Ruta.Paranjape@uth.tmc.edu   
Contact: Marcie Kern, PT, MS    713-799-6995    Marcie.Kern@memorialhermann.org   
Principal Investigator: Shuo-Hsiu Chang, PT, PhD         
Sponsors and Collaborators
Ekso Bionics
Burke Medical Research Institute
Investigators
Principal Investigator: Dylan Edwards, PhD Burke Medical Research Institute

Publications:
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

Responsible Party: Ekso Bionics
ClinicalTrials.gov Identifier: NCT02943915     History of Changes
Other Study ID Numbers: 105333
First Posted: October 25, 2016    Key Record Dates
Last Update Posted: August 9, 2018
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 Injuries
Spinal Cord Injuries
Back Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System