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Eden Prairie, MN 55344-3636
Walkasins® is a non-invasive lower limb Sensory Neuroprosthesis for individuals with peripheral neuropathy who have gait and balance impairments. RxFunction, Inc. has recently registered and listed Walkasins® with the FDA, but Walkasins is not yet available for sale.
The walk2Wellness Clinical Trial will evaluate Walkasins® use on about 100 patients from multiple sites across the country for up to one year. The randomized cross-over trial will involve patients with sensory peripheral neuropathy who experience gait and balance problems and are at high risk of falling. Plans call for participants to be tested for gait function, balance confidence and social participation measures at baseline and after 2, 6, 10, 26, and 52 weeks, with 10 weeks being the primary end-point of the study.
Recruitment of patients for the walk2Wellness Clinical Trial is beginning this fall and will be handled by the participating sites. For study site locations, enrollment status and requirements, please visit: clinicaltrials.gov