The WISE Trial - Walking Improvement for SCI With Exoskeleton (WISE)
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|ClinicalTrials.gov Identifier: NCT02943915|
Recruitment Status : Completed
First Posted : October 25, 2016
Last Update Posted : September 11, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Injuries, Spinal Cord||Device: Ekso GT Rehabilitation Therapy Device: Body Weight Supported (BWS) Treadmill Training||Not Applicable|
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:
- To examine the economic factors such as number of physical therapists/staff required during training.
- To analyze the physical burden on therapists assisting and supervising during training.
- 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)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- 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.
- 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.
- 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.
- 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
- 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).
- Numeric Pain Rating Scale [ Time Frame: Weeks 1-12 ]Numeric Pain Rating Scale for self-reported neuropathic pain upon resting and during gait training.
- 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.
- 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
- 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.
- 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.
- Spinal Cord Injury Functional Ambulatory Index (SCI-FAI) [ Time Frame: Baseline, Evaluations week 6, 12, and 24 ]Quality assessment of gait pattern
- 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.
- Body Mass Index (BMI) [ Time Frame: Baseline, Evaluations week 6, 12, and 24 ]General health measure.
- Upper and Lower Extremity Muscle Strength [ Time Frame: Baseline, Evaluations week 6 and 24 ]As measured by physical therapist for muscle strength.
- Spinal Cord Assessment Tool for Spastic Reflexes (SCATS) Modified Ashworth Scale [ Time Frame: Baseline, Evaluations week 6, 12, and 24 ]Spasticity measurement.
- Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET) [ Time Frame: Baseline, Evaluations week 6, 12, 24 ]Participant reported spasticity measurement.
- Numeric Rating of Spasticity [ Time Frame: Baseline and weekly assessments for 12 weeks ]Participant reported spasticity measurement.
- Heart Rate [ Time Frame: Baseline, Weekly training sessions 1 - 12, Evaluations week 6, 12 and 24 ]Physiological outcomes: heart rate
- 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.
- Modified International SCI Bowel Function Basic Data Set [ Time Frame: Baseline, Evaluations week 6, 12 and 24 ]Participant assessment of bowel function
- 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.
- Incidence of Pressure Ulcers [ Time Frame: Baseline, each training session 1 through 36. ]Skin integrity check.
- Incidence of Falls [ Time Frame: Each training session 1 through 36, Evaluations week 6, 12 and 24 ]Assessed at each visit via participant report.
- 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.
- Therapist Borg Rating of Perceived Exertion Scale (Borg) [ Time Frame: Weeks 1 through 12 ]Self-reported perceived exertion.
- Therapist National Aeronautics and Space Administration (NASA) Task Load Index [ Time Frame: Weeks 1 through 12 ]Self-reported work load assessment.
- Participant National Aeronautics and Space Administration (NASA) Task Load Index [ Time Frame: Weeks 1 through 12 ]Self-reported work load assessment.
- Video Assessment of Physical Therapist Posture [ Time Frame: Week 1 and Week 12 ]Independent assessment of shoulder, neck, and trunk posture.
- Therapist Report of Pain and/or Injury [ Time Frame: Up to Week 12 ]Therapist self-reported questionnaire.
- Blood Pressure [ Time Frame: Baseline, Evaluations week 6, 12 and 24 ]Physiological outcomes: blood pressure
- Gait Quality [ Time Frame: Baseline, Evaluations week 6, 12 and 24 ]GAITRite for temporospatial gait parameters and symmetry
- Berg Balance Scale [ Time Frame: Baseline, Evaluations week 6, 12 and 24 ]Measurement of static and dynamic sitting and standing balance
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|
- Motor incomplete paraplegia or tetraplegia
- 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)
- Sufficient diaphragmatic strength such that respiration is not compromised with exercise.
- 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)
- AIS-C SCI & AIS-D SCI, as determined by the International Standards for Neurological Classification of SCI (ISNCSCI)
- Ambulates at <0.44 meters/second with or without physical assistance and assistance device
- WISCI ≥ 1
- 18 - 75 yrs, inclusive
- No current or history of other neurological conditions
- Screened and cleared by a physician
- Involved in standing program or must be able to tolerate at least 15 min upright
- Weigh 220 pounds (100kg) or less
- Be able to fit into the Ekso device
- Approximately between 5'0" and 6'4" tall
- Standing hip width of approximately 18" or less
- Have near normal range of motion in hips, knees and ankles
- AIS-A SCI or AIS-B SCI
- Lower motor neuron injuries, as shown by absent reflexes during bilateral quadriceps and Achilles tendon taps
- < 3 months since previous intensive gait training regimen
- Already walking at self-selected ambulation speeds of at least 0.44 meter/second with or without assistance
- Currently involved in another intervention study
- Concurrent neurological disease
- Hip flexion contracture greater than ~17°
- Knee flexion contracture greater than 12°
- Unable to achieve neutral ankle dorsiflexion with passive stretch (neutral with max 12° knee flexion)
Leg length discrepancy
- Greater than 0.5" for upper leg
- Greater than 0.75" for lower leg
- Spinal instability
- Unresolved deep vein thrombosis
- Uncontrolled autonomic dysreflexia
- Severe muscular or skeletal pain
- 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.
- Open skin ulcerations on buttocks or other body surfaces in contact with exoskeleton or harness
- Cognitive impairments - unable to follow 2 steps commands and communicate for pain or to stop session
- Shoulder extension Range of Motion (ROM) < 50° excludes crutches during sit to stand or vice versa. (Walking with crutches permitted.)
- Participant requires the assistance of more than one therapist to transfer safely.
- 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
- Active heterotrophic ossification (HO), hip dysplasia or hip/knee axis abnormalities
- History of long bone fractures since the SCI, secondary to osteoporosis
- Unable to sustain current medication regimen
- Any reason the physician may deem as harmful to the participant to enroll or continue in the study
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
|United States, Arizona|
|Barrow Neurological Institute at St. Joseph's Hospital and Medical Center|
|Phoenix, Arizona, United States, 85013|
|United States, Connecticut|
|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|
|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|
|Principal Investigator:||Dylan Edwards, PhD||Burke Medical Research Institute|
|Responsible Party:||Ekso Bionics|
|Other Study ID Numbers:||
|First Posted:||October 25, 2016 Key Record Dates|
|Last Update Posted:||September 11, 2019|
|Last Verified:||August 2018|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries