{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T05:52:14Z","timestamp":1791265934065,"version":"4.1.0"},"reference-count":47,"publisher":"JMIR Publications Inc.","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JMIR Rehabil Assist Technol"],"abstract":"Abstract<\/jats:title>\n \n Background<\/jats:title>\n Personalized prosthetic socket design depends upon highly skilled prosthetists. They aim to balance functional human-prosthesis coupling with safe, comfortable load transmission from the prosthesis to the skeleton, through vulnerable skin and soft tissues. Both traditional plaster and computer-aided design and manufacturing (CAD\/CAM) methods are iterative, and sharing knowledge is difficult. Evidence-generated (EG) sockets derived from past computer-aided socket design (CASD) records could provide a personalized starting point for limb fitting, potentially reducing time spent on basic design and enabling prosthetists to focus on more highly-skilled customization.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n This study aimed to assess the comfort of EG sockets, generated from past CASD records.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n A crossover trial compared EG sockets, derived from 163 previous transtibial devices, with conventional clinician-led CAD\/CAM sockets. Noninferiority was assessed for the socket comfort score (SCS) outcome measure, and semistructured interviews provided in-depth user analysis. The setting was 3 UK National Health Service clinics, with 17 participants with 19 transtibial amputations.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n EG sockets had no statistically significant difference in comfort compared with clinician-led control sockets (median SCS 8.6 for EG sockets and 8.8 for CAD\/CAM controls;\n P<\/jats:italic>\n =.43, effect size=0.05), but a lower variability in SCS across the group (95% CIs 8.0\u20109.0 for EG and 7.5\u20109.5 for CAD\/CAM devices, respectively). Analysis of interviews revealed themes around fitting session experiences, similarities, and differences between the EG and CAD\/CAM control sockets, and residual limb factors impacting perceptions of socket comfort. These provided insights into the participants\u2019 experience of the study and the value of expert prosthetist input in socket design.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n EG sockets demonstrated noninferiority to conventional clinical CASD practice in terms of socket comfort. Both quantitative and qualitative results indicated how clinician input remains essential and is valued by prosthesis users. Work is underway to incorporate the EG sockets into CASD software such that they can act as a digital starting point for modification by expert clinicians at fitting, potentially reducing time spent on basic design, enabling prosthetists to focus on more highly-skilled customization and co-design with their patients.<\/jats:p>\n <\/jats:sec>","DOI":"10.2196\/69962","type":"journal-article","created":{"date-parts":[[2025,8,21]],"date-time":"2025-08-21T22:11:42Z","timestamp":1755814302000},"page":"e69962-e69962","source":"Crossref","is-referenced-by-count":6,"title":["Evidence-Generated Sockets for Transtibial Prosthetic Limbs Compared With Conventional Computer-Aided Designs: A Multiple-Methods Study From the Patient\u2019s Perspective"],"prefix":"10.2196","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6103-7996","authenticated-orcid":false,"given":"Florence","family":"Mbithi","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3398-845X","authenticated-orcid":false,"given":"Maggie","family":"Donovan-Hall","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0414-3984","authenticated-orcid":false,"given":"Jennifer","family":"Bramley","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6288-1347","authenticated-orcid":false,"given":"Joshua","family":"Steer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7547-0256","authenticated-orcid":false,"given":"Charalambos","family":"Rossides","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0145-5042","authenticated-orcid":false,"given":"Peter","family":"Worsley","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8267-2892","authenticated-orcid":false,"given":"Chantel","family":"Ostler","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7404-6066","authenticated-orcid":false,"given":"Cheryl","family":"Metcalf","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-4352-4598","authenticated-orcid":false,"given":"Dominic","family":"Hannett","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-8378-2506","authenticated-orcid":false,"given":"Caroline","family":"Ward","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-8369-6593","authenticated-orcid":false,"given":"Jack","family":"Kitchen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-1929-2715","authenticated-orcid":false,"given":"Sioned","family":"Steventon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-3457-6111","authenticated-orcid":false,"given":"Katy","family":"McIntosh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3227-5503","authenticated-orcid":false,"given":"Shigong","family":"Guo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-1824-1685","authenticated-orcid":false,"given":"Helen","family":"Harvey","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4650-3888","authenticated-orcid":false,"given":"David","family":"Henderson Slater","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-8302-3559","authenticated-orcid":false,"given":"Vijay","family":"Kolli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9647-1944","authenticated-orcid":false,"given":"Alex","family":"Dickinson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1010","published-online":{"date-parts":[[2025,8,21]]},"reference":[{"issue":"1","key":"R1","doi-asserted-by":"publisher","first-page":"17","DOI":"10.3109\/03093648509164819","article-title":"Computer aided design of prosthetic sockets for below-knee amputees","volume":"9","author":"Saunders","journal-title":"Prosthetics & Orthotics International"},{"issue":"1","key":"R2","doi-asserted-by":"publisher","first-page":"19","DOI":"10.3109\/03093648909079405","article-title":"Comparison of CAD-CAM and hand made sockets for PTB prostheses","volume":"13","author":"K\u00f6hler","journal-title":"Prosthet Orthot Int"},{"issue":"3","key":"R3","doi-asserted-by":"publisher","first-page":"136","DOI":"10.3109\/03093649009080339","article-title":"An evaluation of computer aided design of below-knee prosthetic sockets","volume":"14","author":"Topper","journal-title":"Prosthet Orthot Int"},{"issue":"3","key":"R4","doi-asserted-by":"publisher","first-page":"189","DOI":"10.3109\/03093649209164339","article-title":"CAD CAM trans-tibial temporary prosthesis: analysis and comparison with an established technique","volume":"16","author":"Ruder","journal-title":"Prosthet Orthot Int"},{"issue":"3","key":"R5","doi-asserted-by":"publisher","first-page":"164","DOI":"10.3109\/03093649309164377","article-title":"Clinical evaluation of trans-tibial prosthesis sockets: a comparison between CAD CAM and conventionally produced sockets","volume":"17","author":"Oberg","journal-title":"Prosthet Orthot Int"},{"issue":"1","key":"R6","doi-asserted-by":"publisher","first-page":"93","DOI":"10.1080\/17461550500066782","article-title":"A work study of the CAD\/CAM method and conventional manual method in the fabrication of spinal orthoses for patients with adolescent idiopathic scoliosis","volume":"29","author":"Wong","journal-title":"Prosthet Orthot Int"},{"issue":"8","key":"R7","doi-asserted-by":"publisher","first-page":"578","DOI":"10.1097\/PHM.0000000000000689","article-title":"Sockets manufactured by CAD\/CAM method have positive effects on the quality of life of patients with transtibial amputation","volume":"96","author":"Karako\u00e7","journal-title":"Am J Phys Med Rehabil"},{"issue":"2","key":"R8","doi-asserted-by":"publisher","first-page":"239","DOI":"10.1016\/j.apmr.2024.08.026","article-title":"Evaluating the effectiveness of transtibial prosthetic socket shape design using artificial intelligence: a clinical comparison with traditional plaster cast socket designs","volume":"106","author":"van der Stelt","journal-title":"Arch Phys Med Rehabil"},{"issue":"4","key":"R9","doi-asserted-by":"publisher","first-page":"78","DOI":"10.1682\/jrrd.1992.10.0078","article-title":"Automated fabrication of mobility aids (AFMA): below-knee CASD\/CAM testing and evaluation program results","volume":"29","author":"Houston","journal-title":"J Rehabil Res Dev"},{"issue":"3","key":"R10","first-page":"327","volume":"38","author":"Smith","journal-title":"J Rehabil Res Dev"},{"issue":"4","key":"R11","doi-asserted-by":"publisher","first-page":"257","DOI":"10.1109\/TBME.1985.325445","article-title":"A software package for design and manufacture of prosthetic sockets for transtibial amputees","volume":"32","author":"Dean","journal-title":"IEEE Trans Biomed Eng"},{"issue":"1","key":"R12","first-page":"42","volume":"31","author":"Boone","journal-title":"J Rehabil Res Dev"},{"issue":"4","key":"R13","doi-asserted-by":"publisher","first-page":"303","DOI":"10.1109\/86.547931","article-title":"A quantitative method for comparing and evaluating manual prosthetic socket modifications","volume":"4","author":"Lemaire","journal-title":"IEEE Trans Rehabil Eng"},{"issue":"5","key":"R14","doi-asserted-by":"publisher","first-page":"1149","DOI":"10.3390\/prosthesis6050083","article-title":"Prosthetist-specific rectification templates based on artificial intelligence for the digital fabrication of custom transtibial sockets","volume":"6","author":"Cutti","journal-title":"Prosthesis"},{"issue":"3","key":"R15","doi-asserted-by":"publisher","first-page":"130","DOI":"10.3109\/03093648909079421","article-title":"A reference shape library for computer aided socket design in above-knee prostheses","volume":"13","author":"Torres-Moreno","journal-title":"Prosthet Orthot Int"},{"issue":"3","key":"R16","doi-asserted-by":"publisher","first-page":"251","DOI":"10.1177\/0309364616684165","article-title":"Quantification of rectifications for the Northwestern University Flexible Sub-Ischial Vacuum Socket","volume":"41","author":"Fatone","journal-title":"Prosthet Orthot Int"},{"key":"R17","doi-asserted-by":"publisher","DOI":"10.1186\/1748-7161-5-19","article-title":"\"Brace Technology\" thematic series - the ScoliOlogiC\u00ae Ch\u00eaneau light\u2122 brace in the treatment of scoliosis","volume":"5","author":"Weiss","journal-title":"Scoliosis"},{"issue":"1","key":"R18","doi-asserted-by":"publisher","first-page":"68","DOI":"10.3109\/09593980903498352","article-title":"The L.A. Brace-description and discussion","volume":"27","author":"Bowman","journal-title":"Physiother Theory Pract"},{"issue":"10","key":"R19","doi-asserted-by":"publisher","DOI":"10.1063\/1.5092743","article-title":"Quantitative compensation design for prosthetic socket based on eigenvector algorithm method","volume":"90","author":"Li","journal-title":"Rev Sci Instrum"},{"issue":"11","key":"R20","doi-asserted-by":"publisher","DOI":"10.3390\/s21113743","article-title":"A sensor-based decision support system for transfemoral socket rectification","volume":"21","author":"Karamousadakis","journal-title":"Sensors (Basel)"},{"key":"R21","doi-asserted-by":"publisher","DOI":"10.1109\/TNSRE.2024.3430070","article-title":"A data-driven design framework for structural optimization to enhance wearing adaptability of prosthetic hands","volume":"32","author":"Gu","journal-title":"IEEE Trans Neural Syst Rehabil Eng"},{"key":"R22","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-024-74504-3","article-title":"A clinical comparison of a digital versus conventional design methodology for transtibial prosthetic interfaces","volume":"14","author":"Lee","journal-title":"Sci Rep"},{"issue":"5","key":"R23","doi-asserted-by":"publisher","first-page":"574","DOI":"10.1097\/PXR.0000000000000351","article-title":"A scoping review of digital fabrication techniques applied to prosthetics and orthotics: Part 1 of 2\u2014Prosthetics","volume":"48","author":"Oldfrey","journal-title":"Prosthetics & Orthotics International"},{"issue":"4","key":"R24","doi-asserted-by":"publisher","first-page":"280","DOI":"10.3390\/prosthesis3040027","article-title":"Characterising residual limb morphology and prosthetic socket design based on expert clinician practice","volume":"3","author":"Dickinson","journal-title":"Prosthesis"},{"issue":"1","key":"R25","doi-asserted-by":"publisher","first-page":"157","DOI":"10.3390\/prosthesis6010013","article-title":"Shape analysis of prosthetic socket rectification procedure for transtibial amputees","volume":"6","author":"Nagarajan","journal-title":"Prosthesis"},{"issue":"1","key":"R26","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-024-56333-6","article-title":"Preliminary characterization of rectification for transradial prosthetic sockets","volume":"14","author":"Ngan","journal-title":"Sci Rep"},{"key":"R27","doi-asserted-by":"publisher","DOI":"10.3389\/fresc.2024.1354069","article-title":"Insights into the spectrum of transtibial prosthetic socket design from expert clinicians and their digital records","volume":"5","author":"Dickinson","journal-title":"Front Rehabil Sci"},{"issue":"11","key":"R28","doi-asserted-by":"publisher","first-page":"867","DOI":"10.2471\/blt.07.045120","article-title":"The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies","volume":"85","author":"von Elm","journal-title":"Bull World Health Organ"},{"key":"R29","unstructured":"The Voices project. People Powered Prosthetics. 2024. URL: https:\/\/www.peoplepoweredprosthetics.com\/projects\/voices\/ [Accessed 18-07-2025]"},{"issue":"1","key":"R30","doi-asserted-by":"publisher","first-page":"11168","DOI":"10.1038\/s41598-024-61234-9","article-title":"An adaptive prosthetic socket for people with transtibial amputation","volume":"14","author":"Sanders","journal-title":"Sci Rep"},{"issue":"3","key":"R31","doi-asserted-by":"publisher","DOI":"10.1016\/j.arrct.2020.100059","article-title":"Perceived effect of socket fit on major lower limb prosthetic rehabilitation: a clinician and amputee perspective","volume":"2","author":"Turner","journal-title":"Arch Rehabil Res Clin Transl"},{"issue":"4","key":"R32","doi-asserted-by":"publisher","first-page":"723","DOI":"10.1080\/09638288.2022.2037745","article-title":"Understanding decision-making in prosthetic rehabilitation by prosthetists and people with lower limb amputation: a qualitative study","volume":"45","author":"Anderson","journal-title":"Disabil Rehabil"},{"key":"R33","doi-asserted-by":"publisher","DOI":"10.3389\/fresc.2023.1335966","article-title":"Advances in prosthetic technology: a perspective on ethical considerations for development and clinical translation","volume":"4","author":"Gavette","journal-title":"Front Rehabil Sci"},{"issue":"6","key":"R34","doi-asserted-by":"publisher","first-page":"797","DOI":"10.1682\/JRRD.2015.12.0228","article-title":"Psychometric evaluation of self-report outcome measures for prosthetic applications","volume":"53","author":"Hafner","journal-title":"J Rehabil Res Dev"},{"issue":"374","key":"R35","doi-asserted-by":"publisher","first-page":"312","DOI":"10.2307\/2287832","article-title":"Censored data and the bootstrap","volume":"76","author":"Efron","journal-title":"J Am Stat Assoc"},{"issue":"2","key":"R36","doi-asserted-by":"publisher","first-page":"77","DOI":"10.1191\/1478088706qp063oa","article-title":"Using thematic analysis in psychology","volume":"3","author":"Braun","journal-title":"Qual Res Psychol"},{"issue":"2","key":"R37","doi-asserted-by":"publisher","first-page":"61","DOI":"10.3109\/03093648609164502","article-title":"Innovation in prosthetics and orthotics","volume":"10","author":"Foort","journal-title":"Prosthet Orthot Int"},{"issue":"4","key":"R38","doi-asserted-by":"publisher","first-page":"366","DOI":"10.1177\/0309364619863922","article-title":"Prosthetics and Orthotics International welcomes qualitative research submissions","volume":"43","author":"Dillon","journal-title":"Prosthet Orthot Int"},{"key":"R39","doi-asserted-by":"publisher","DOI":"10.2147\/RMHP.S7500","article-title":"Improving health outcomes with better patient understanding and education","volume":"3","author":"Adams","journal-title":"Risk Manag Healthc Policy"},{"issue":"1","key":"R40","doi-asserted-by":"publisher","first-page":"26","DOI":"10.1097\/PXR.0000000000000142","article-title":"Improving shared decision-making for prosthetic care: a qualitative needs assessment of prosthetists and new lower-limb prosthesis users","volume":"47","author":"Anderson","journal-title":"Prosthet Orthot Int"},{"issue":"3","key":"R41","doi-asserted-by":"publisher","first-page":"282","DOI":"10.1097\/PXR.0000000000000107","article-title":"Understanding the adoption of digital workflows in orthotic & prosthetic practice from practitioner perspectives: a qualitative descriptive study","volume":"46","author":"Ngan","journal-title":"Prosthetics & Orthotics International"},{"key":"R42","unstructured":"Twiste M . Limbless statistics annual report: 2011\/2012. University of Salford Manchester; 2015. URL: https:\/\/shop.salford.ac.uk\/product-catalogue\/university-goods-and-services\/limbless-statistics\/limbless-statistics-annual-report-201112"},{"issue":"1","key":"R43","doi-asserted-by":"publisher","first-page":"19","DOI":"10.1177\/0309364616628341","article-title":"The impact of gender, level of amputation and diabetes on prosthetic fit rates following major lower extremity amputation","volume":"41","author":"Davie-Smith","journal-title":"Prosthet Orthot Int"},{"issue":"s1","key":"R44","doi-asserted-by":"publisher","first-page":"75","DOI":"10.1017\/cts.2024.229","article-title":"250 gender disparities in the acquisition of lower extremity prosthetics following major limb amputation","volume":"8","author":"Levy","journal-title":"J Clin Trans Sci"},{"issue":"1","key":"R45","doi-asserted-by":"publisher","first-page":"e18","DOI":"10.1097\/JPO.0000000000000470","article-title":"Identifying and acknowledging a sex gap in lower-limb prosthetics research: a review","volume":"36","author":"Ljung","journal-title":"J Prosthet Orthot"},{"issue":"6","key":"R46","doi-asserted-by":"publisher","first-page":"1201","DOI":"10.1016\/j.apmr.2021.10.008","article-title":"Measurements of best, worst, and average socket comfort are more reliable than current socket comfort in established lower limb prosthesis users","volume":"103","author":"Morgan","journal-title":"Arch Phys Med Rehabil"},{"key":"R47","unstructured":"Mbithi F Donovan-Hall M Bramley JL et al. Evidence-generated sockets for transtibial prosthetic limbs: a multiple-methods study from the patient\u2019s perspective, compared to conventional computer-aided designs. University of Southampton Institutional Repository. URL: https:\/\/eprints.soton.ac.uk\/493705\/ [Accessed 25-07-2025]"}],"container-title":["JMIR Rehabilitation and Assistive Technologies"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/rehab.jmir.org\/2025\/1\/e69962","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T17:58:16Z","timestamp":1782842296000},"score":1,"resource":{"primary":{"URL":"https:\/\/rehab.jmir.org\/2025\/1\/e69962"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,8,21]]},"references-count":47,"URL":"https:\/\/doi.org\/10.2196\/69962","relation":{},"ISSN":["2369-2529"],"issn-type":[{"value":"2369-2529","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,8,21]]},"article-number":"v12i1e69962"}}