RxFunction Inc announces its plans to conduct the walk2Wellness study, a long-term clinical trial to assess the long-term mobility and quality of life benefits among walkasins users living with peripheral neuropathy.
The trial announcement was made in conjunction with Peripheral Neuropathy Awareness Week (May 6-12), sponsored by The Foundation for Peripheral Neuropathy.
Peripheral neuropathy, a common consequence of diabetes or chemotherapy, is a disorder in which the nerves of the feet are damaged. It can cause numbness and pain, and can lead to loss of balance function and increase the risk of falls, according to a media release from Eden Prairie, Minn-based RxFunction Inc, creator of walkasins, a wearable sensory prosthesis.
Walkasins consists of a thin sensor-instrumented foot pad placed in the shoe that measures changes in foot pressure reflecting the patient’s state of balance. The Foot Pad connects to a leg unit that contains a micro-processor and a proprietary algorithm that activates vibrator motors placed around the leg to provide new tactile balance cues to the patient.
Leaning too far in any one direction triggers a vibration on that side of the leg signaling to the brain to correct balance. Patients can then better sense where their feet are on the ground, helping them to improve balance and mobility, the release explains.
The walk2Wellness clinical trial will evaluate walkasins use on 100 patients from multiple sites across the country for up to 1 year. The randomized, cross-over trial will involve patients with sensory peripheral neuropathy experiencing gait and balance problems who are at high risk of falling.
Plans call for participants to be tested for gait function, balance confidence, and social participation measures immediately and after 10, 26 and 52 weeks, with 10 weeks being the primary end-point of the study. Recruitment of patients for the walk2Wellness study is expected to begin this summer and will be handled by the participating sites.
The walk2Wellness trial will build upon a recent study of walkasins at the Veterans Administration Medical Center in Minneapolis that demonstrated short-term immediate improvement of walkasins on functional balance and walking speed resulting in reduced fall-risk in a majority of patients, the release continues.
“Already we have seen remarkable results with individual patients showing significant improvements in gait outcomes, reducing fall risks and walking more confidently using walkasins,” says Dr Lars Oddsson, who co-invented and developed the patented technology while a research professor at Boston University’s Neuromuscular Research Center, in the release.
“We now hope to determine that walkasins can provide sustained longer-term improvement in clinical and patient reported outcomes. In addition, we expect to identify which patients receive the most significant benefits from our technology. The data we collect in the walk2Wellness study will help us address insurance and Medicare reimbursement for walkasins,” he adds.
[Source: RxFunction Inc]