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

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), Article e045195. 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