N/A
N=45
The WISE Trial - Walking Improvement for SCI With Exoskeleton
Injuries, Spinal Cord
Bottom Line
View on ClinicalTrials.gov: NCT02943915 ↗Enrolled (actual)
45
Serious AEs
4.4%
Results posted
Oct 2023
Primary outcome: Primary: Change in Gait Speed From Baseline to 12 Weeks Using 10 Meter Walk Test (10MWT) — 0.18; 0.07; 0.03 meters/second
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ekso GT Rehabilitation Therapy (Device); Body Weight Supported (BWS) Treadmill Training (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ekso Bionics
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Gait Speed From Baseline to 12 Weeks Using 10 Meter Walk Test (10MWT) |
0.18; 0.07; 0.03 | — |
| SECONDARY 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 |
3; 2; 0 | — |
| SECONDARY Change in Distance Covered Over 6 Minutes From Baseline to 24 Weeks |
538; 346.6; 320 | — |
| SECONDARY Change in Time Required to Complete Timed Up and Go (TUG) Test From Baseline to 24 Week Follow up |
26.4; 30; 46 | — |
| SECONDARY Number of Participants Who Experienced a Fall During Protocol |
0; 0; 0 | — |
| SECONDARY Change in Berg Balance Scale Score From Baseline to 24 Weeks |
18.7; 19.22; 17.3 | — |
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
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02943915). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.