The WISE Trial - Walking Improvement for SCI With Exoskeleton

Study Overview
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Brief Summary
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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
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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.).

Official Title
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The WISE Trial - Walking Improvement for SCI With Exoskeleton

Conditions
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Injuries, Spinal Cord

Intervention / Treatment
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* Device: Ekso GT Rehabilitation Therapy
* Device: Body Weight Supported (BWS) Treadmill Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 Pregnancy 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 Colostomy 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Ekso GT Rehabilitation Therapy<br>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<br>* Walking Improvement for Spinal Cord Injuries with Exoskeleton<br>* Other names: Exoskeleton;|
| Active Comparator: Group 2: Active controls - BWSTT Therapy<br>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<br>* Standard gait training using BWS PT and overground training<br>* Other names: Conventional Therapy;|
| No Intervention: Group 3: Passive controls<br>Participants in this group continue with normal daily activities over 12 weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Gait Speed From Baseline to 12 Weeks Using 10 Meter Walk Test (10MWT) | The mean change in gait speed demonstrated during the 10MWT after 12 weeks of training and compared between groups. Positive values indicate improvement in gait speed (faster) from baseline to 12 weeks. Negative values indicate a reduction in gait speed (slower) from baseline to 12 weeks. | Baseline and 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Number of participants who achieve the Minimal Clinically Important Difference (MCID) of 0.15 m/s during the 10MWT when comparing between baseline gait speed and gait speed at 24 weeks. | Between baseline and 24 weeks | 
| Change in Distance Covered Over 6 Minutes From Baseline to 24 Weeks | 6 minute walk test (6MWT) completed at baseline and 24 weeks. Change assessed. Positive values indicate an increase in distance was able to be walked at 24 weeks versus at baseline. Negative values indicate a decrease in distance was walked at 24 weeks versus at baseline. | Baseline-24 weeks | 
| Change in Time Required to Complete Timed Up and Go (TUG) Test From Baseline to 24 Week Follow up | Examined balance and walking in participants at baseline and follow up at 24 weeks. Positive values indicate an improvement of time (less time) required to complete task at 24 week follow up versus at baseline. Negative values indicate a decline, more time required to complete task at follow up versus baseline. | Baseline and 24 weeks | 
| Number of Participants Who Experienced a Fall During Protocol | At each training session, assessed if participant had experienced any falls. Count is number of participants who reported that yes, they did experience a fall. | Throughout 24 weeks | 
| Change in Berg Balance Scale Score From Baseline to 24 Weeks | Measurement of static and dynamic sitting and standing balance completed at baseline and at 24 weeks. Berg balance scale is a 14 item test with each item scored from 0-4. Possible scores range from 0-56. Higher scores indicate a lower risk of falls and better balance. Positive numbers indicate an improvement in Berg balance scale (scored out of 56), meaning that the participant scored higher at 24 weeks than at baseline. Negative values indicate a decline in performance of the Berg balance scale (scored out of 56), meaning that the participant scored lower at 24 weeks than at baseline. | Baseline-24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal Cord, Injury, Exoskeleton, Ekso, Rehabilitation