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STEPFORWARD study: a randomised controlled feasibility trial of a self-aligning prosthetic ankle-foot for older patients with vascular-related amputations

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

Authors

Elizabeth Coleman

Judith Watson

Kerry Bell

Cleveland Barnett

Catriona McDaid

Martin Twiste

Fergus Jepson

Abayomi Salawu

Dennis Harrison

Natasha Mitchell



Abstract

Objectives 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.

Design Multicentre parallel group feasibility RCT.

Setting Five prosthetics centres in England recruiting from July 2018 to August 2019.

Participants Adults aged ≥50 years with a vascular-related or non-traumatic transtibial amputation for 1 year or longer, categorised as having ‘limited community mobility’ and using a non-self-aligning ankle-foot.

Intervention Participants were randomised into one of two groups for 12 weeks: self-aligning prosthetic ankle-foot or existing non-self-aligning prosthetic ankle-foot.

Outcomes 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.

Results 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% CI 0.39 to 2.1). Completeness of questionnaires ranged from 89%–94%, and clinical assessments were 92%–95%, including the activity monitor data. The average completion rates for the EQ-5D-5L and bespoke resource use questionnaire were 93% and 63%, respectively.

Conclusions This feasibility trial recruited and retained participants who were categorised as having ‘limited community mobility’ 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.

Citation

Vanicek, N., Coleman, E., Watson, J., Bell, K., Barnett, C., McDaid, C., …Mitchell, N. (2021). STEPFORWARD study: a randomised controlled feasibility trial of a self-aligning prosthetic ankle-foot for older patients with vascular-related amputations. BMJ open, 11(3), https://doi.org/10.1136/bmjopen-2020-045195

Journal Article Type Article
Acceptance Date Feb 23, 2021
Online Publication Date Mar 18, 2021
Publication Date 2021-03
Deposit Date Mar 19, 2021
Publicly Available Date Mar 22, 2021
Journal BMJ Open
Print ISSN 2044-6055
Electronic ISSN 2044-6055
Publisher BMJ Publishing Group
Peer Reviewed Peer Reviewed
Volume 11
Issue 3
Article Number e045195
DOI https://doi.org/10.1136/bmjopen-2020-045195
Keywords General Medicine
Public URL https://hull-repository.worktribe.com/output/3742426

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Publisher Licence URL
https://creativecommons.org/licenses/by/4.0/

Copyright Statement
© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/
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/.





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