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The overall goal of this project is to continue development and commercialization of a Wearable Sensory Prosthesis termed Walkasins. The device measures foot pressure through a thin sole insert, developed under National Institute on Aging (NIA) Small Business Innovation Research (SBIR) Phase I funding, and displays pressure information through a vibrotactile feedback array, placed around the lower leg, to help improve balance function. The device can replace lost foot pressure sensation in individuals with peripheral neuropathy who have balance problems.
Our specific aims are to: 1. Revise and finalize design of Walkasins® based on accomplishments, user input, as well as reviewer criticism from our Phase 1 grant and manufacture 200 units of the device for clinical testing. Milestone 1: 200 units manufactured and ready for clinical testing under Aim 2. This goal is accomplished. 2. Investigate effects of using Walkasins on clinical outcomes related to gait, balance function and associated fall risk in a population of patients with sensory peripheral neuropathy and balance problems. Hypotheses 1A-B: Patients who are trained to use Walkasins programmed to display relevant balance cues will attain higher gait speed and Functional Gait Assessment when compared to a matched cohort not using Walkasins. Milestone 2: Data collection to assess clinical utility and safety of the Walkasins on patients briefly trained to use the device has been completed.
Age
All ages
Sex
ALL
Healthy Volunteers
No
Start Date
May 1, 2016
Primary Completion Date
July 28, 2017
Completion Date
July 28, 2017
Last Updated
October 30, 2018
31
ACTUAL participants
Walkasins ON
DEVICE
Walkasins OFF
DEVICE
Lead Sponsor
RxFunction Inc.
Collaborators
NCT07423390
NCT07352514
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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