A randomized cross-over study of peripheral neuropathy patients, led by Sara Koehler-McNicholas, PhD at the Minneapolis VA Adaptive Design and Engineering Program, has found that short-term use of Walkasins®, a product created by medical device company RxFunction
Eden Prairie, MN – (May 3, 2019) – A randomized cross-over study of peripheral neuropathy patients, led by Sara Koehler-McNicholas, PhD at the Minneapolis VA Adaptive Design and Engineering Program, has found that short-term use of Walkasins®, a product created by medical device company RxFunction™, improved balance and gait speed and lowered fall-risk among participating patients who lack sensation in their feet and are at high risk of falls.
Results of the study, which involved 31 male Veterans, aged 56 – 84, who were patients of the Minneapolis VA Medical Center, were published April 30, 2019 in PLOS ONE. All participants in the study were at high fall-risk, with a majority having fallen in the last six months.
“This clinical research study demonstrates significant immediate improvements in balance and gait speed with short-term use of Walkasins®, and more than half of the patients were moved from high fall-risk to normal fall-risk classification in the clinic,” said Lars Oddsson, PhD, scientist and RxFunction co-founder, who developed the patented technology for Walkasins®. The study was conducted in collaboration with the Center for Veterans Research and Education under a grant from the National Institutes of Health (NIH).
Findings of the study included that: “…sensory balance information provided by the Walkasins® device more than doubled the likelihood of improving clinical outcomes of gait and balance function…”
Benefits of long-term use of Walkasins® are now being studied in the walk2Wellness trial, underway at several medical clinics across the country. More information about the walk2Wellness trial can be found here.
Tom Morizio, CEO of RxFunction, noted the significance of this week’s published clinical research. “Clinical evidence to demonstrate the value of Walkasins® is one of the most significant drivers for adoption of our new technology and is critical for commercial success. This published study, our current walk2Wellness trial, and further planned human trials are essential to demonstrating how Walkasins® benefits patients, lowers fall risk, and improves quality of life when used by patients who can benefit from the technology.”
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Walkasins® was created to help improve balance in patients who experience gait and mobility problems due to sensory peripheral neuropathy, a disorder where the nerves in the feet are damaged causing numbness. This can lead to loss of balance and increase the risk of falls. 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.
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 a Small Business Innovation Research grant from the National Institutes of Health (AG040865) and the product is manufactured in Minnesota. RxFunction, Inc. has registered with the U.S. Food & Drug Administration (FDA); Walkasins® is listed with the FDA and is not yet available for sale. (http://www.rxfunction.com)
About PLOS ONE
The world’s first multidisciplinary Open Access journal, PLOS ONE accepts scientifically rigorous research, regardless of novelty. PLOS ONE’s broad scope provides a platform to publish primary research including interdisciplinary and replication studies as well as negative results. The journal’s publication criteria are based on high ethical standards and the rigor of the methodology and conclusions reported.
