A wearable sensory neuroprosthesis to improve gait and balance function in persons with sensory peripheral neuropathy-the walk2wellness trial

Objective: Determine effects of long-term home-based use of a wearable lower limb sensory neuroprosthesis in patients with sensory peripheral neuropathy (PN) on balance and gait function, quality of life, physical activity/participation, pain and fall rates. This is an update from the ongoing multi-site clinical trial, walk2Wellness (NCT #03538756, www.clinicaltrials.gov), Background: PN patients commonly present with gait and balance problems which increase their fall risk, limit their mobility and social participation. The Walkasins® (RxFunction Inc., MN, USA) is designed to replace lost nerve function related to foot pressure sensation by providing tactile cues around the ankle reflecting foot pressure measured with an instrumented in-shoe foot pad. We have hypothesized that previously shown short-term improvements in gait and balance will be sustained long-term. Design/Methods: Participants have PN, loss of plantar sensation with gait and balance problems and Functional Gait Assessment (FGA) score <23 (high fall risk cut-off in community dwelling elderly individuals), but intact vibration sense around the ankle. Clinical outcomes include FGA, Gait Speed, Timed Up & Go and Four-Stage Balance Test. Patient-reported outcomes include Activities-Specific Balance Confidence scale, Vestibular Activities of Daily Living, Pain rating, and falls. Evaluations occur at initial visit, 2, 6, 10, 26 and 52 weeks. Subjects are blinded to changes in outcomes. Up to 120 patients will be enrolled at five sites, four currently active. Results: Currently, 43 participants are enrolled, mean age 74.1 yrs (range 44-89), FGA score 14.8 (7-22), gait speed 0.87m/s (0.35-1.30), 157 device use-days, 60% fell in the past 6 months. At 10 weeks of use 30 participants show improved FGA score from 14.6 to 18.6. Six-month pre-study fall-rate has decreased from 8.1 to 4.2 falls/1,000 patient days (across all participants, 157 average use-days). Conclusions: A wearable sensory neuroprosthesis may provide a new way to treat gait and balance problems in high fall risk patients with PN.