Disclosures: Lars Oddsson, PhD: RxFunction Inc.: Employment, Officer or Board Member, Ownership Interest, Royalties, Stockholder/Ownership Interest (excluding diversified mutual funds)

Objective: Patients who lose plantar sensation from sensory peripheral neuropathy (PN) commonly experience problems with gait and balance that can increase risk of falls. The walk2Wellness clinical trial (clinicaltrials.gov, NCT #03538756) is testing a new wearable device indicated for these patients, a lower limb sensory neuroprosthesis to substitute for lost plantar sensation, to help improve gait and balance function.

Design: The trial investigates long-term use effects (52 weeks) on clinical and patient-reported outcomes of balance and gait function, quality of life, physical activity/participation and pain. The study will enroll up to 150 patients across six sites in five states 2018-2020.

Setting: Home-based daily use.

Participants: Community dwelling elderly individuals with PN and Functional Gait Assessment (FGA) score <23, cut-off for high fall-risk. Able to perform FGA without an assistive device to indicate sufficient motor function to act on new sensory information.

Interventions: The device, Walkasins® (RxFunction Inc., MN, USA), provides gentle directional tactile cues around the lower leg during standing and walking reflecting changes in foot pressure distribution measured with an instrumented foot pad in the shoe. Patients react to new sensory cues to improve gait and balance.

Main Outcome Measures: FGA, Gait Speed, Timed Up & Go (TUG), 4-Stage Balance Test (4STB), Vestibular Activities of Daily Living and Activities-Specific Balance Confidence (ABC) and PROMIS scores on social participation and satisfaction with participation. Fall-rates are monitored and compared to pre-study data.

Results: To date (February 2019), 20 subjects (15 Male, 5 Female) across three sites have been enrolled with baseline outcomes; FGA 14.4, Gait Speed 0.80m/s, TUG 14.9s, 4STB 26.3s and ABC 61%. Six-month pre-study fall-rate, 8.3 falls/1000 patient days (11 of 20 were fallers). Five falls occurred to date, 2 on snow and ice, 2 in bathroom, 1 trip on fence line, two while wearing the device.

Conclusions: Pending clinical data, subjects have expressed satisfaction with device and show improving outcomes.

Level of Evidence: Level II

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PM&R Meeting Abstracts - https://pmrjabstracts.org/abstract/slips-and-falls-and-record-snow-in-minnesota-walk2wellness-clinical-trial-update/