Led by Dylan Edwards, Ph.D., P.T., (multi-site PI) and Mar Cortes M.D. (site Principal investigator) the randomized, controlled study, entitled WISE (Walking Improvement for SCI with Exoskeletons), will evaluate improvement in independent gait speeds of spinal cord injury (SCI) patients undergoing rehabilitation with the Ekso GT™, the Ekso Bionics’ medical robotic exoskeleton, and will be compared to both conventional therapy and usual care control groups. The US-based study, which will be conducted in up to 8 centers, seeks to enroll approximately 160 community dwelling people with chronic incomplete SCI.
“We are thrilled to partner with Ekso Bionics to further study the Ekso GT, a cutting-edge technology that can offer life-changing benefits to patients,” said Dr. Edwards. “We have observed physical and psychosocial benefits of gait training with the Ekso GT, and we are excited to expand upon our early findings and to help support the pathway for exoskeletons as part of standard care for these patients.”
The multicenter WISE study incorporates three randomized clinical arms as follows:
In addition there will be a “run in” group of up to 40 participants who will serve to help with protocol refinement. Participants in the “run in” group will receive the Ekso GT for rehabilitation and will be followed for 12 weeks.
All groups will be evaluated at baseline, 6 weeks, and 12 weeks. The primary endpoint of the WISE study seeks to demonstrate that a 12-week robotic gait training regimen can lead to a clinically meaningful improvement in independent walking speed. Secondary endpoints from the trial will examine economic factors such as number of physical therapists (PTs) and staff required during training, the physical burden on PTs assisting and supervising during training and the influence of factors that may modify the gait recovery.
“The initiation of the WISE study – our first ever company-sponsored clinical trial - is an important and exciting milestone for our company as we execute our strategy and commercialize our products. We believe this study will continue to demonstrate the clinical and economic benefits of our medical robotic exoskeletons,” said Thomas Looby, CEO and President of Ekso Bionics.
Ekso™ GT is the first FDA cleared exoskeleton cleared for use with stroke and spinal cord injuries from L5 to C7. The Ekso GT with smart Variable Assist™ (marketed as SmartAssist outside the U.S.) software is the only exoskeleton available for rehabilitation institutions that can provide adaptive amounts of power to either side of the patient’s body, challenging the patient as they progress through their continuum of care. The suit’s patented technology provides the ability to mobilize patients earlier, more frequently and with a greater number of high intensity steps. To date, this device has helped patients take more than 55 million steps in over 120 rehabilitation institutions around the world.