Participants who reported falls over 6 months prior to the study had a 43% decrease in fall rate during the study; Improvements in gait and balance seen at 10 weeks of use were sustained at 26 weeks
Eden Prairie, MN, October 7, 2022 – Results of the walk2Wellness trial of the Walkasins® Lower Limb Sensory Prosthesis show that the device improves balance and substantially decreases incidence of falls during long-term use among people suffering from Peripheral Neuropathy (PN). The study results are published in Frontiers in Aging Neuroscience.
The walk2Wellness trial assessed falls and self-reported balance outcomes from 44 individuals with PN after 26 weeks of device use. Participants had clinically diagnosed PN with impaired plantar sensation, high fall risk (Functional Gait Assessment, FGA score <23), and ability to sense stimuli above the ankle at the location of the device.
“Individuals with peripheral neuropathy often experience issues with balance when standing and walking due to loss of sensation in the bottom of the feet,” said Lars I.E. Oddsson, PhD, chief technology officer of RxFunction and co-inventor of Walkasins. “This sensory impairment leads to problems with gait and balance function and increases the risk of falling. The walk2Wellness study suggests that long-term use of Walkasins, a wearable lower limb sensory prosthesis, improves clinical outcomes and may substantially reduce falls for people with PN.”
Overall, the walk2Wellness trial showed clinically meaningful improvements in outcomes seen at 10 weeks of use remained sustained at 26 weeks with statistically significant results. Notably, participants who reported falls over 6 months prior to the study had a 43% decrease in fall rate during the study as compared to self-report 6-month pre-study.
“Loss of sensory information from plantar mechanoreceptors alters balance performance, and affects the automaticity of walking, which increases an individual’s need for cognitive attention to gait and mobility activities,” said Oddsson. “When using Walkasins, patients can ‘feel’ their feet in contact with the ground, because the device replaces aspects of their impaired nerve function. The device provides directional tactile mechanical stimuli around the ankle during standing and walking, reflecting changes in foot pressure related to balance. These very exciting results suggest that it is possible to restore an important degree of automaticity of balance and walking, offering individuals the ability to better engage in the daily activities of life.”
Falls are a leading cause of injury and death among older Americans. PN, which leads to nerve damage and numbness in the feet, is recognized as an independent risk factor for falls. The prevalence of PN in the U.S. population for those over age 40 is nearly 15%, and over 28% in persons with diabetes.
For more information about the walk2Wellness Trial, visit (direct to published article on Frontiers). To learn more about the Walkasins Lower Limb Sensory Prosthesis, visit www.walkasins.com.
About Walkasins and RxFunction
Walkasins by RxFunction is an innovative medical device for individuals struggling with balance and mobility due to sensory peripheral neuropathy. RxFunction is a medical device company with a mission to design and market medical technologies that restore balance, increase mobility, and enhance confidence for people at risk of falling. Privately held and headquartered in Eden Prairie, Minnesota, RxFunction created the Walkasins Lower Limb Sensory Prosthesis, building upon patented technology developed by co-founder and scientist Lars Oddsson, PhD. Development of Walkasins was supported by a Small Business Innovation Research grant from the National Institutes of Health (AG040865) and the product is manufactured in Minnesota. For more information about Walkasins and RxFunction, visit www.rxfunction.com.