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Self-aligning prosthetic device for older patients with vascular-related amputations: protocol for a randomised feasibility study (the STEPFORWARD study)

Mitchell, Natasha; Coleman, Elizabeth; Watson, Judith; Bell, Kerry; McDaid, Catriona; Barnett, Cleveland; Twiste, Martin; Jepson, Fergus; Salawu, Abayomi; Harrison, Dennis; Vanicek, Natalie


Natasha Mitchell

Elizabeth Coleman

Judith Watson

Kerry Bell

Catriona McDaid

Cleveland Barnett

Martin Twiste

Fergus Jepson

Abayomi Salawu

Dennis Harrison


Introduction The majority of older patients with a transtibial amputation are prescribed a standard (more rigid, not self-aligning) prosthesis. These are mostly suitable for level walking, and cannot adjust to different sloped surfaces. This makes walking more difficult and less energy efficient, possibly leading to longer term disuse. A Cochrane Review concluded that there was insufficient evidence to recommend any individual type of prosthetic ankle-foot mechanism. This trial will establish the feasibility of conducting a large-scale trial to assess the effectiveness and cost-effectiveness of a self-aligning prosthesis for older patients with vascular-related amputations and other health issues compared with a standard prosthesis.
Methods and analysis This feasibility trial is a pragmatic, parallel group, randomised controlled trial (RCT) comparing standard treatment with a more rigid prosthesis versus a self-aligning prosthesis. The target sample size is 90 patients, who are aged 50 years and over, and have a transtibial amputation, where amputation aetiology is mostly vascular-related or non-traumatic. Feasibility will be measured by consent and retention rates, a plausible future sample size over a 24-month recruitment period and completeness of outcome measures. Qualitative interviews will be carried out with trial participants to explore issues around study processes and acceptability of the intervention. Focus groups with staff at prosthetics centres will explore barriers to successful delivery of the trial. Findings from the qualitative work will be integrated with the feasibility trial outcomes in order to inform the design of a full-scale RCT.
Ethics and dissemination Ethical approval was granted by Yorkshire and the Humber—Leeds West Research Ethics Committee on 4 May 2018. The findings will be disseminated via peer-reviewed research publications, articles in relevant newsletters, presentations at relevant conferences and the patient advisory group.


Mitchell, N., Coleman, E., Watson, J., Bell, K., McDaid, C., Barnett, C., …Vanicek, N. (2019). Self-aligning prosthetic device for older patients with vascular-related amputations: protocol for a randomised feasibility study (the STEPFORWARD study). BMJ open, 9(9), Article e032924.

Journal Article Type Article
Acceptance Date Jul 18, 2019
Online Publication Date Sep 20, 2019
Publication Date 2019-08
Deposit Date Oct 21, 2019
Publicly Available Date Oct 22, 2019
Journal BMJ Open
Print ISSN 2044-6055
Electronic ISSN 2044-6055
Publisher BMJ Publishing Group
Peer Reviewed Peer Reviewed
Volume 9
Issue 9
Article Number e032924
Keywords General Medicine
Public URL
Publisher URL
Contract Date Oct 22, 2019


Published article (517 Kb)

Copyright Statement
© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY.
Published by BMJ.

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