Subject Recruitment

Human subject testing was approved according to the Declaration of Helsinki by Advarra IRB (formerly Quorum Review IRB), serving as the Institutional Review Board (IRB) of record for three of the participating sites under the study protocol for walk2Wellness: Long-term Use Effects of Walkasins^® Wearable Sensory Prosthesis on Gait Function, Balance-Confidence, and Social Participation. The three sites include Baylor College of Medicine, Houston, TX; Hebrew SeniorLife, a Harvard Medical School Affiliate, Boston, MA; and M Health Fairview, Minneapolis, MN. Advarra IRB determined that Walkasins are a non-significant risk device because they do not meet the criteria of a significant risk device according to U.S. Food and Drug Administration regulations. The IRB Subcommittee, the Subcommittee on Research Safety, and the Research and Development Committee of the Minneapolis VA Health Care System (MVAHCS) also approved the trial. The study is registered on ClinicalTrials.gov (#{"type":"clinical-trial","attrs":{"text":"NCT03538756","term_id":"NCT03538756"}}NCT03538756). At the time this study began, Walkasins were available only for research purposes. All data from the trial was collected and stored using REDCap Cloud, a 21 CFR Part 11 compliant Electronic Data Capture system (Encinitas, CA, United States).