Ekso Bionics® to Expand Clinical Trial Sites for Comparative Multicenter WISE Study
RICHMOND, Calif., Feb. 12, 2018 (GLOBE NEWSWIRE) -- Ekso Bionics Holdings, Inc. (NASDAQ:EKSO), an industry leader in exoskeleton technology for medical and industrial use, today announced that it will be expanding the first company-sponsored randomized, controlled clinical trial, the WISE (Walking Improvement for SCI with Exoskeletons) study, to TIRR Memorial Herman and Barrow Neurological Institute. Led by Dylan Edwards, Ph.D., P.T., of the Burke Medical Research Institute, the U.S. based-study, which will now be conducted at ten centers, will evaluate improvement in independent gait speeds of patients with spinal cord injuries (SCI) who are receiving rehabilitation with the EksoGT™, the Company's wearable exoskeleton, compared to standard of care.
In addition to the two new participating WISE study sites, the following centers have been initiated:
- Burke Medical Research Institute
- Courage Kenny Rehabilitation Institute
- DMC Rehabilitation Institute of Michigan
- Gaylord Hospital
- Kennedy Krieger Institute
- Kessler Foundation
- Marianjoy Rehabilitation Hospital, part of Northwestern Medicine
- Shirley Ryan AbilityLab
"We have witnessed a significant level of interest in this trial evaluating the EksoGT™, which enables individuals with stroke or spinal cord injuries to stand up and walk with a full weight bearing, reciprocal gait," remarked Dr. Edwards. "We look forward to reporting data from this trial in Q2 2019."
The multicenter WISE study incorporates three randomized clinical arms. Participants in Group 1 will undergo rehabilitation with a combination of the EksoGT™ and overground walking three times a week for 12 weeks. Group 2 will undergo rehabilitation consisting of standard gait training three times a week utilizing a combination of body-weight supported treadmill training and overground training for 12 weeks. Group 3 will be a passive control group; participants will continue with normal daily activities for 12 weeks with no therapy.
Separately, a "run in" group of up to 40 participants will help with protocol refinement. Participants in the "run in" group will receive the EksoGT™ for rehabilitation and will be tracked 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 and staff required during training, the physical burden on physical therapists assisting and supervising during training, and the influence of factors that may modify the gait recovery.
"We are pleased to extend our research into the role of exoskeleton-assisted walking in the rehabilitation of individuals with spinal cord injury," said Gail Forrest, PT, Ph.D., associate director of Human Performance & Engineering Research at Kessler Foundation. "The multi-center WISE study is an important step toward determining the impact of the EksoGT™ on recovery of mobility," Dr. Forrest noted. "Since our initial partnership with Ekso Bionics in 2011, our capabilities for conducting mobility research have grown exponentially. Combined with our expertise in spinal cord injury, gait analysis, locomotor training, robotic technology, and therapy training requirements, we are well positioned to contribute to outcomes of the WISE study."
Building upon the success of the WISE study and the EksoGT™, Ekso Bionics will be showcasing the EksoGT™ at the following conferences:
- Association of Academic Physiatrists (AAP) 2018 Meeting
February 13-17, 2018 in Atlanta, GA
- American Physical Therapy Association Combined Sections Meeting (CSM) 2018
February 21-24, 2018 in New Orleans, LA
For more information about Ekso Bionics or the EksoGT™, visit: www.eksobionics.com.
EksoGT™ is the first exoskeleton cleared by the FDA for use with stroke and spinal cord injuries from L5 to C7. The EksoGT with SmartAssist™ software is the only exoskeleton available for rehabilitation institutions that can provide adaptive amounts of power to either side of a 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 80 million steps in over 185 rehabilitation institutions around the world.
About Ekso Bionics®
Ekso Bionics® is a leading developer of exoskeleton solutions that amplify human potential by supporting or enhancing strength, endurance and mobility across medical and industrial applications. Founded in 2005, the company continues to build upon its unparalleled expertise to design some of the most cutting-edge, innovative wearable robots available on the market. Ekso Bionics is the only exoskeleton company to offer technologies that range from helping those with paralysis to stand up and walk, to enhancing human capabilities on job sites across the globe. The company is headquartered in the Bay Area and is listed on the Nasdaq Capital Market under the symbol EKSO. For more information, visit: www.eksobionics.com.
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