Ekso Bionics, the California-based maker of the GT exoskeleton, has enrolled the first patient into its first company-sponsored clinical trial. The study, called WISE (Walking Improvement for SCI with Exoskeletons), will compare improvements in independent gait speeds of spinal cord injury (SCI) patients rehabbing with the Ekso GT to patients rehabbing with conventional therapy and to 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. Dylan Edwards, Ph.D., P.T., of The Burke Medical Research Institute, who will lead the study. “We have observed physical and psycho-social 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.”
Ekso said the WISE study will include three randomized clinical arms:
- Group 1 will rehab with the Ekso GT three times a week for 12 weeks.
- Group 2 will rehab using standard gait training three times a week for 12 weeks, using body-weight supported treadmill training and overground training.
- Group 3 will be a passive control group in which participants continue with daily activities as normal over 12 weeks with no therapy.
There will also 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.
Ekso said the clinical study will also examine how many physical therapists (PTs) and staff are 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 Ekso GT exoskeleton, the world’s only FDA-approved exoskeleton for use with spinal and stroke victims, recently started using the network and global Internet of Things (IoT) SIM from telecommunications giant Vodafone to ensure reliable communications for diagnostics and improved access to patient data with the exoskeleton.
The Ekso GT exoskeleton is designed to help physical therapists mobilize patients earlier, more frequently and with a greater number of high-intensity steps. It is strapped over the users clothing, enabling individuals to achieve mobility, strength, or endurance not otherwise possible. The Ekso GT can provide adaptive amounts of power to either side of the patient’s body, helping to improve results for patients.
The Ekso GT exoskeleton is currently available in the United States, Mexico, Canada, South Africa, and in most European countries. The Ekso GT is offered in more than 150 leading rehabilitation institutions around the world and has helped enable its users to take more than 50 million steps not otherwise possible.