Multi-site clinical trial confirms improved gait, balance function, and decreased fall risk in patients with Peripheral Neuropathy.
Eden Prairie, MN – The medical device company, RxFunction announced today that peer-reviewed data from long-term, home-based daily use of Walkasins®, a wearable sensory prosthesis, has been published in Frontiers in Aging Neuroscience under the special Research Topic “Novel Technologies to Measure and Modulate the Supraspinal Control of Standing and Walking in Older Adults” (read article).
RxFunction developed Walkasins Lower Limb Sensory Prosthesis to improve balance and reduce fall risk in patients with sensory peripheral neuropathy who experience gait and mobility problems due to lost sensation in the plantar surface of the feet. This loss of sensory information results in poor balance and increased falls. Walkasins replaces this lost nerve function by providing tactile stimuli related to changes in foot pressure during standing and walking. According to the National Institutes of Health, an estimated 20 million Americans have some form of peripheral neuropathy, commonly a consequence of diabetes and chemotherapy, and widely present in the elderly population.
The walk2Wellness clinical trial (www.clinicaltrials.gov NCT03538756), involved five leading U.S. medical centers, including the Hinda and Arthur Marcus Institute for Aging Research/Harvard Medical School, Johns Hopkins School of Medicine, Baylor College of Medicine, the Minneapolis Department of Veterans Affairs Health Care System and M Health Fairview/University of Minnesota.
The study assessed clinical outcomes of gait function, balance, quality of life, and fall rates in patients wearing Walkasins over 10 weeks of daily home-based use. The study met the primary endpoint and confirmed the hypothesis that daily use of the Walkasins device would lead to meaningful improvement in clinical outcomes and decrease fall risk in high fall-risk patients. The walk2Wellness trial builds upon the company’s previously published clinical trial conducted together with Minneapolis Department of Veterans Affairs Health Care System on a cohort of Veterans (PLOS ONE).
“The walk2Wellness data provides strong support for the use of Walkasins as a clinical treatment for gait and balance function in patients with balance problems related to peripheral neuropathy,” states Lars Oddsson, PhD., Principal Investigator, CTO of RxFunction, and co-inventor of the Walkasins technology. “By simply wearing the device we can improve gait and balance function, reduce fall risk and improve patient confidence.”
“There are few options to treat balance problems associated with peripheral neuropathy,” said Mary Anderson, Chief Executive Officer at RxFunction. “We are excited to share these findings and provide clinicians a proven solution to treat their patients suffering with gait and balance challenges.”
About RxFunction, Inc.
RxFunction™ is a medical device company with a mission to design and market medical technologies that restore balance, increase mobility, and enhance confidence for patients 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 Small Business Innovation Research grants from the National Institutes of Health (AG040865) and the product is manufactured in Minnesota. To learn more about RxFunction and Walkasins, including about product safety information, visit www.rxfunction.com.