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

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

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. Trial registration number: ISRCTN15043643.

• Journal Article Type: Article
• Acceptance Date: Feb 23, 2021
• Online Publication Date: Mar 18, 2021
• Publication Date: Mar 18, 2021
• Deposit Date: Mar 22, 2021
• Publicly Available Date: Mar 22, 2021
• Journal: BMJ Open
• Electronic ISSN: 2044-6055
• Publisher: BMJ Publishing Group
• Volume: 11
• Issue: 3
• Pages: e045195
• DOI: https://doi.org/10.1136/bmjopen-2020-045195
• Publisher URL: http://dx.doi.org/10.1136/bmjopen-2020-045195
• Related Public URLs: https://bmjopen.bmj.com/
• Additional Information: Additional Information : ** Embargo end date: 18-03-2021 ** From BMJ via Jisc Publications Router ** Licence for this article starting on 18-03-2021: https://creativecommons.org/licenses/by/4.0/ **Journal IDs: eissn 2044-6055 **Article IDs: publisher-id: bmjopen-2020-045195 **History: published_online 18-03-2021; published 03-2021; accepted 23-02-2021; rev-recd 18-02-2021; submitted 26-09-2020; Funders : National Institute for Health Research (NIHR);Hull University Teaching Hospitals NHS Trust; Projects : Research for Patient Benefit (RfPB) Programme; Grant Number: PB-PG-0816-20029