{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,17]],"date-time":"2026-04-17T08:08:38Z","timestamp":1776413318827,"version":"3.51.2"},"reference-count":44,"publisher":"Public Library of Science (PLoS)","issue":"5","license":[{"start":{"date-parts":[[2024,5,2]],"date-time":"2024-05-02T00:00:00Z","timestamp":1714608000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/publicdomain\/zero\/1.0\/"}],"funder":[{"name":"Office of the Assistant Secretary of Defense for Health Affairs","award":["W81XWH-21-2-0049"],"award-info":[{"award-number":["W81XWH-21-2-0049"]}]},{"name":"Center for Limb Loss and MoBility VA RR&D","award":["I50 RX002357"],"award-info":[{"award-number":["I50 RX002357"]}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:sec id=\"sec001\">\n<jats:title>Background<\/jats:title>\n<jats:p>Ankle-foot orthoses (AFOs) are commonly used to overcome mobility limitations related to lower limb musculoskeletal injury. Despite a multitude of AFOs to choose from, there is scant evidence to guide AFO prescription and limited opportunities for AFO users to provide experiential input during the process. To address these limitations in the current prescription process, this study evaluates a novel, user-centered and personalized \u2018test-drive\u2019 strategy using a robotic exoskeleton (\u2018AFO emulator\u2019) to emulate commercial AFO mechanical properties (i.e., stiffness). The study will determine if brief, in-lab trials (with emulated or actual AFOs) can predict longer term preference, satisfaction, and mobility outcomes after community trials (with the actual AFOs). Secondarily, it will compare the in-lab experience of walking between actual vs. emulated AFOs.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec002\">\n<jats:title>Methods and analysis<\/jats:title>\n<jats:p>In this participant-blinded, randomized crossover study we will recruit up to fifty-eight individuals with lower limb musculoskeletal injuries who currently use an AFO. Participants will walk on a treadmill with three actual AFOs and corresponding emulated AFOs for the \"in-lab\u201d assessments. For the community trial assessment, participants will wear each of the actual AFOs for a two-week period during activities of daily living. Performance-based and user-reported measures of preference and mobility will be compared between short- and long-term trials (i.e., in-lab vs. two-week community trials), and between in-lab trials (emulated vs. actual AFOs).<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec003\">\n<jats:title>Trial registration<\/jats:title>\n<jats:p>The study was prospectively registered at <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.clininicaltrials.gov\" xlink:type=\"simple\">www.clininicaltrials.gov<\/jats:ext-link> (Clinical Trials Study ID: <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT06113159\" xlink:type=\"simple\">NCT06113159<\/jats:ext-link>). Date: November 1<jats:sup>st<\/jats:sup> 2023. <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/classic.clinicaltrials.gov\/ct2\/show\/NCT06113159\" xlink:type=\"simple\">https:\/\/classic.clinicaltrials.gov\/ct2\/show\/NCT06113159<\/jats:ext-link>.<\/jats:p>\n<\/jats:sec>","DOI":"10.1371\/journal.pone.0302389","type":"journal-article","created":{"date-parts":[[2024,5,2]],"date-time":"2024-05-02T17:25:07Z","timestamp":1714670707000},"page":"e0302389","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":2,"title":["A patient-centered \u2018test-drive\u2019 strategy for ankle-foot orthosis prescription: Protocol for a randomized participant-blinded trial"],"prefix":"10.1371","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6976-8021","authenticated-orcid":true,"given":"Benjamin 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C. Holtkamp","year":"2015","journal-title":"Clinical Research on Foot & Ankle"},{"issue":"4","key":"pone.0302389.ref024","doi-asserted-by":"crossref","first-page":"202","DOI":"10.1097\/JPO.0000000000000409","article-title":"Robotic Emulation of Candidate Prosthetic Foot Designs May Enable Efficient, Evidence-Based, and Individualized Prescriptions","volume":"34","author":"JM Caputo","year":"2022","journal-title":"J Prosthet Orthot"},{"key":"pone.0302389.ref025","doi-asserted-by":"crossref","unstructured":"Morgenroth DC, Halsne EG, Turner AT, T.R. R, Hansen AH, Walker NR, et al., editors. A Multi-site randomized, cross-over study of a \"test-drive\" strategy for prosthetic foot prescription. 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