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

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Mitchell, N., Coleman, E., Watson, J., Bell, K., McDaid, C., Barnett, C. ORCID: 0000-0001-6898-9095, Twiste, M., Jepson, F., Salawu, A., Harrison, D. and 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): e032924. ISSN 2044-6055

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Official URL: http://doi.org/10.1136/bmjopen-2019-032924

Abstract

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.

Item Type:

Journal article

Publication Title:

BMJ Open

Creators:

Mitchell, N., Coleman, E., Watson, J., Bell, K., McDaid, C., Barnett, C., Twiste, M., Jepson, F., Salawu, A., Harrison, D. and Vanicek, N.

Publisher:

BMJ Publishing Group

Date:

August 2019

Volume:

Number:

ISSN:

2044-6055

Identifiers:

Number	Type
10.1136/bmjopen-2019-032924	DOI

Rights:

© author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

Divisions:

Schools > School of Science and Technology

Record created by:

Linda Sullivan

Date Added:

08 Aug 2019 10:00

Last Modified:

30 Sep 2019 14:43

URI:

https://irep.ntu.ac.uk/id/eprint/37192