RxFunction, the medical device company that created Walkasins®, is announcing expansion of its walk2Wellness study to include researchers at Hebrew SeniorLife, with enrollment of its first participant completed earlier this month. For more information on this topic, see the IDTechEx report on Wearable Technology Forecasts 2019-2029.
The Hinda and Arthur Marcus Institute at Hebrew SeniorLife, a Harvard Medical School affiliate, is the fourth study site of RxFunction's walk2Wellness long-term clinical trial (www.clinicaltrials.gov NCT03538756), designed to assess the effectiveness of using Walkasins Lower Limb Sensory Neuroprosthesis on peripheral neuropathy patients at high fall-risk. This study will build upon the company's previous research trial with veterans that found short-term use of Walkasins immediately improved balance function and gait speed associated with lowered fall-risk among a majority of patients, as recently published in the PLOS ONE journal. Walkasins is intended to replace the nerve function used for detection and signaling of foot pressure sensation. The other three study sites are Minneapolis VA Health Care System, Minneapolis, MN; M Health Fairview, Saint Paul, MN; and Baylor College of Medicine, Houston, TX.
Lewis A. Lipsitz, M.D., Director, Marcus Institute, Chief Academic Officer, Hebrew SeniorLife, and Professor of Medicine, Harvard Medical School, and Brad Manor, Ph.D., Associate Scientist, Marcus Institute, and Assistant Professor of Medicine, Harvard Medical School, are leading the study at the Marcus Institute.
"I am delighted that Drs. Lew Lipsitz and Brad Manor at the Marcus Institute will head up the fourth site in our walk2Wellness study," says Lars Oddsson, Ph.D., CTO-Co-Founder of RxFunction. "I have known Dr. Lipsitz and followed his work since my tenure at Boston University. He is a world-renowned key opinion leader who has led a number of ground-breaking studies in this field, including the NIH-funded MOBILIZE Boston Study (Maintenance of Balance, Independent Living, Intellect and Zest in the Elderly of Boston), one of the most comprehensive studies on the elderly ever." Oddsson continues, "The area of experience and expertise this team brings is directly aligned with the goals of the walk2Wellness trial."
Oddsson shares, "In addition to the long-term effects of Walkasins use on clinical outcomes that we study in the walk2Wellness trial, Marcus Institute will also conduct a pilot study on a subset of participants using structural and functional magnetic resonance imaging of the brain before and after a six-month period of daily Walkasins use." Oddsson adds, "This may help us better understand mechanisms of action and is very exciting."
Walkasins is an external lower limb sensory prosthesis intended to replace the nerve function used for detection and signaling of foot pressure sensation. The company 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 are available by 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, visit www.rxfunction.com .
About RxFunction Inc
RxFunctionTM 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.
Source: RxFunction Inc