Study of Walkasins Device Use to Improve Balance and Walking in Adults 55 and Older with Peripheral Neuropathy

What this Trial Is About

Researchers are evaluating the effects of Walkasins, a wearable sensory device, on balance and gait in people aged 55 and older with peripheral neuropathy and balance problems. The study aims to determine if daily use of Walkasins over six months improves participants awareness of foot placement and reduces fall risk. This randomized controlled trial compares participants using Walkasins to a control group not using the device initially, with a focus on a Medicare-representative population. Participants in the user group will receive Walkasins, which consists of two parts for each leg a Haptic Module that provides tactile cues and a Receptor Sole that senses foot pressure. They will use the device for one year, while the control group receives fall prevention education during the first six months and then Walkasins for the final six months. Both groups will receive fall prevention information. During the study, participants will attend visits and phone calls to complete functional gait and balance tests, answer medical and balance history questions, and keep track of any falls. Researchers will monitor outcomes such as Functional Gait Assessment, patient-reported functional scales, timed walking tests, balance tests, and quality of life measures at multiple time points up to one year. The study also evaluates safety and device experience throughout participation.

Balance4Mobility: Effects of Walkasins Use in Individuals With Peripheral Neuropathy and Balance Problems