{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T01:37:05Z","timestamp":1787017025096,"version":"build-2736575974"},"reference-count":33,"publisher":"BMJ","issue":"3","license":[{"start":{"date-parts":[[2021,3,18]],"date-time":"2021-03-18T00:00:00Z","timestamp":1616025600000},"content-version":"unspecified","delay-in-days":17,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2021,2,23]]},"published-print":{"date-parts":[[2021,3]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To determine the feasibility of conducting a full-scale randomised controlled trial (RCT) of the effectiveness and cost-effectiveness of a self-aligning prosthetic ankle-foot compared with a standard prosthetic ankle-foot.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>Multicentre parallel group feasibility RCT.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>Five prosthetics centres in England recruiting from July 2018 to August 2019.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Participants<\/jats:title>\n                    <jats:p>Adults aged \u226550 years with a vascular-related or non-traumatic transtibial amputation for 1\u2009year or longer, categorised as having \u2018limited community mobility\u2019 and using a non-self-aligning ankle-foot.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Intervention<\/jats:title>\n                    <jats:p>Participants were randomised into one of two groups for 12 weeks: self-aligning prosthetic ankle-foot or existing non-self-aligning prosthetic ankle-foot.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Outcomes<\/jats:title>\n                    <jats:p>Feasibility measures: recruitment, consent and retention rates; and completeness of questionnaire and clinical assessment datasets across multiple time points. Feasibility of collecting daily activity data with wearable technology and health resource use data with a bespoke questionnaire.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Fifty-five participants were randomised (61% of the target 90 participants): n=27 self-aligning ankle-foot group, n=28 non-self-aligning ankle-foot group. Fifty-one participants were included in the final analysis (71% of the target number of participants). The consent rate and retention at final follow-up were 86% and 93%, respectively. The average recruitment rate was 1.25 participants\/site\/month (95%\u2009CI 0.39 to 2.1). Completeness of questionnaires ranged from 89%\u201394%, and clinical assessments were 92%\u201395%, including the activity monitor data. The average completion rates for the EQ-5D-5L and bespoke resource use questionnaire were 93% and 63%, respectively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>This feasibility trial recruited and retained participants who were categorised as having \u2018limited community mobility\u2019 following a transtibial amputation. The high retention rate of 93% indicated the trial was acceptable to participants and feasible to deliver as a full-scale RCT. The findings support a future, fully powered evaluation of the effectiveness and cost-effectiveness of a self-aligning prosthetic ankle-foot compared with a standard non-self-aligning version with some adjustments to the trial design and delivery.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"ISRCTN15043643\">ISRCTN15043643<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2020-045195","type":"journal-article","created":{"date-parts":[[2021,3,18]],"date-time":"2021-03-18T13:15:53Z","timestamp":1616073353000},"page":"e045195","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":3,"title":["STEPFORWARD study: a randomised controlled feasibility trial of a self-aligning prosthetic ankle-foot for older patients with vascular-related amputations"],"prefix":"10.1136","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9602-3172","authenticated-orcid":false,"given":"Natalie","family":"Vanicek","sequence":"first","affiliation":[{"name":"Department of Sport, Health and Exercise Science, University of Hull, Hull, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth","family":"Coleman","sequence":"additional","affiliation":[{"name":"York Trials Unit, Department of Health Sciences, University of York, York, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0694-3854","authenticated-orcid":false,"given":"Judith","family":"Watson","sequence":"additional","affiliation":[{"name":"York Trials Unit, Department of Health Sciences, University of York, York, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kerry","family":"Bell","sequence":"additional","affiliation":[{"name":"York Trials Unit, Department of Health Sciences, University of York, York, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3751-7260","authenticated-orcid":false,"given":"Catriona","family":"McDaid","sequence":"additional","affiliation":[{"name":"York Trials Unit, Department of Health Sciences, University of York, York, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cleveland","family":"Barnett","sequence":"additional","affiliation":[{"name":"School of Science and Technology, Nottingham Trent University, Nottingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Twiste","sequence":"additional","affiliation":[{"name":"School of Health and Society, University of Salford, Manchester, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fergus","family":"Jepson","sequence":"additional","affiliation":[{"name":"Specialist Mobility Rehabilitation Centre, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2496-0826","authenticated-orcid":false,"given":"Abayomi","family":"Salawu","sequence":"additional","affiliation":[{"name":"Disability Medicine and Rehabilitation Unit, Hull University Teaching Hospitals NHS Trust, Hull, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dennis","family":"Harrison","sequence":"additional","affiliation":[{"name":"Public Involvement Member, UK, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Natasha","family":"Mitchell","sequence":"additional","affiliation":[{"name":"York Trials Unit, Department of Health Sciences, University of York, York, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2021,3,18]]},"reference":[{"key":"2025121403244280000_11.3.e045195.1","unstructured":"University of Salford . 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