Study of the Wearable Walkasins Device to Improve Walking, Balance, and Physical Activity in Adults with Peripheral Neuropathy

What this Trial Is About

Researchers are evaluating whether sensory stimulations from a wearable neuroprosthesis device called Walkasins can increase physical activity and improve walking quality in adults aged 60 and older with peripheral neuropathy PN. The study focuses on whether Walkasins enhances daily activity patterns and balance in this population, who experience sensory loss in their feet leading to balance impairments. This is a prospective within-participant study conducted over one year, where participants serve as their own control. Participants will undergo baseline assessments including balance, walking tests, questionnaires, and a 10-day monitoring period of habitual physical activity without using Walkasins. After these baseline measures, participants receive the Walkasins device, which includes an insole and an ankle strap that delivers gentle vibrations to provide sensory feedback. They will wear the device daily for 10 weeks while repeating activity monitoring and assessments to track changes in physical activity and gait quality. Throughout the study, participants will perform balance and walking tasks, including a six-minute walk test without assistive devices, and complete questionnaires about medical history, balance confidence, and sleep. They will wear an activity monitor activPAL for 10 days at baseline, at the start of Walkasins use, and after 10 weeks of use. Researchers will measure outcomes such as metabolic equivalent activity scores, step counts, sedentary time, and various physical function tests to understand the devices impact on mobility and balance over approximately 12 weeks.

Wearable Sensory Prosthesis to Improve Coordination, Walking, and Physical Activity