RxFunction (Eden Prairie, Minn.) recently announced that it plans to conduct its first long-term clinical trial of its wearable sensory prosthetic Walkasins in the Walk2Wellness study.

The Walk2Wellness clinical trial plans to evaluate how well Walkasins work on 100 patients from different locations across the U.S. The patients will all have sensory peripheral neuropathy with gait and balance problems and are at high risk of falling. patients will be tested for gait function, balance confidence and social participation at the start of the study and after 10, 26 and 52 weeks. RxFunction plans to start recruiting participants this summer.

RxFunction’s clinical trial will follow a recent study of the Walkasins at the Veterans Administration Medical Center in Minneapolis that showed short-term immediate improvement of Walkasins on function balance and walking speed. As a result, study participants had a reduced fall-risk.

“Already we have seen remarkable results with individual patients showing significant improvements in gait outcomes, reducing fall risks and walking more confidently using Walkasins,” said Lars Oddsson, co-inventor and developer of the patented technology. “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.”

[Hear Oddsson talk about fundraising in medtech at DeviceTalks Minnesota, June 4–5 in St. Paul.]

RxFunction recently raised $7.5 million in Series A funding to prepare to launch its Walkasins. The Walkasins have a leg unit and foot pad that work together to give immediate gentle and tactile sensory cues so users can control balance and stability. A thin sensor-instrumented foot pad is placed inside the shoe that measures foot pressure. The foot pad is connected to the leg unit that has a micro-processor and algorithm that can activate vibrator motors around the leg to give tactile balance cues to patients. Leaning too far in one direction will set the vibrations off on that side of the leg to let the brain know to correct balance.

A Wingate University department of physical therapy professor recently conducted a long-term case study on a patient who was using Walkasins everyday for a year.

“The patient has shown dramatic and sustained improvement in several clinical outcome measures, demonstrating normal performance on several of these measures,” Diane Wrisley, the professor who conducted the study, said. “He is more active while using Walkasins.”