RxFunction, announced positive interim results from its walk2Wellness study on Walkasins, a product designed to help peripheral neuropathy patients with balance issues. The results were presented by Lars Oddsson, PhD, Chief Technology Officer of RxFunction, at the American Congress of Rehabilitation Medicine in November 2019.
The research update represented interim data from the first 30 subjects with sensory peripheral neuropathy who have reached the 10-week primary study endpoint. The data shows clinically meaningful improvements with the use of Walkasins in mean Functional Gait Assessment (FGA) scores (from 14.6 to 18.6), a measure of balance and gait used to indicate fall risk, and that is typically low in those with peripheral neuropathy, and mean normal walking speed (from .86 to .93 meters per second).
Interim results across all 42 subjects enrolled at 150 average use days also shows a substantial reduction in patient reported fall rate with the use of Walkasins, from 8.1 to 4.2 falls per 1000 patient days.
The walk2Wellness long-term study is designed to determine the effectiveness of Walkasins, a lower limb sensory neuroprosthesis, in peripheral neuropathy patients with a high risk of falling. The study began in late 2018 and is currently underway at four U.S. medical centers. The study is evaluating Walkasins impact in over 100 patients for one year. More information about study site locations, enrollment status, and requirements can be found here.