Ekso Bionics Holdings has enrolled first patient in the clinical trial, which will assess the efficacy of its medical robotic exoskeleton.
The randomized, controlled study will assess improvement in independent gait speeds of spinal cord injury (SCI) patients undergoing rehabilitation with the Ekso GT, the company’s medical robotic exoskeleton, and will be compared to both conventional therapy and usual care control groups.
The US-based study results will also be compared with both conventional therapy and usual care control groups.
Ekso will recruit around 160 community dwelling people with chronic incomplete SCI in the study, which will be carried out at around eight centers.
The study’s leader Dylan Edwards said: “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 study includes three randomized clinical arms where participants randomized to group one will receive the Ekso GT for rehabilitation three times a week for 12 weeks, while
The participants randomized to group two will secure standard gait training for rehabilitation three times a week using a combination of body-weight supported treadmill training and overground training for 12 weeks
The participants randomized to group three will be a passive control group in which participants continue with daily activities as normal over 12 weeks with no therapy
In addition, the 40 participants in run in group will receive the Ekso GT for rehabilitation and will be followed for 12 weeks.
According to the company, the primary endpoint of the WISE study seeks to show that a 12-week robotic gait training regimen can lead to a clinically meaningful improvement in independent walking speed.
Ekso Bionics CEO and president Thomas Looby said: “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.”