walk2Wellness interim study data demonstrate improvement in balance, walking speed and fall reduction
walk2Wellness interim study data demonstrate improvement in balance, walking speed and fall reduction1
Eden Prairie, MN - (November 5, 2019) – RxFunction is presenting an update on walk2Wellness clinical research at the American Congress of Rehabilitation Medicine (ACRM) 2019 Annual Conference on November 5th – 8th in Chicago, Illinois, the largest interdisciplinary rehabilitation conference in the world.
Lars Oddsson, PhD, co-inventor of Walkasins® and Chief Technology Officer of RxFunction will give a platform talk in the “Intensive Cross Cutting Session” titled, “A Wearable Device for Sensory Motor Recovery, Function and Balance” on Wednesday, November 6, 2019 at 2:12 pm. In addition, Dr. Oddsson will present a symposium titled “Sensory Neuromodulation to Improve Physical Function in Persons with Peripheral Neuropathy” on Thursday, November 7, 2019 from 1:30 PM – 2:45 PM together with Dr. Helen Cohen of Baylor College of Medicine and Dr. Diane Wrisley of Wingate University, who are members of the walk2Wellness clinical research team. The searchable conference schedule can be found here.
The research update represents 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. “We are pleased to be able to share this interim study data at ACRM to help those interested in Walkasins technology understand what we’re seeing in our ongoing clinical research,” commented RxFunction CEO, Tom Morizio.
“It is an honor to have two talks accepted at this highly reputable conference and to present together with two key opinion leaders in the area of balance rehabilitation, Drs. Cohen and Wrisley”, says Oddsson. “It reflects the growing interest in the Walkasins technology and provides an important opportunity to share an update of the walk2Wellness trial that has now reached 42 participants and over 6,000 patient-use days, highlighting important current balance, gait and falls data from the trial.”
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.
Walkasins is an external lower limb sensory prosthesis intended to replace the nerve function used for detection and signaling of foot pressure sensation. RxFunction developed Walkasins 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. Walkasins is available in certain markets in the U.S. with a prescription following evaluation by a trained clinician. 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. To learn more about Walkasins, including about risks associated with using Walkasins, please visit www.rxfunction.com.
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.
1Oddsson, LIE., Cohen, H., Wrisley, DM. (2019, Nov.) A Wearable Device for Sensory Motor Recovery, Function and Balance. Presentation presented at the 96th Annual meeting of the American Congress of Rehabilitation Medicine, Chicago, IL.
© 2019 RxFunction, Inc. All Rights Reserved. AP-10077v0 1911. Walkasins® and RxFunction™ are trademarks of RxFunction, Inc.--
