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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

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JournalBMJ Open
DateAccepted/In press - 23 Feb 2021
DateE-pub ahead of print (current) - 18 Mar 2021
Early online date18/03/21
Original languageEnglish

Abstract

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 vascularrelated 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 anklefoot 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-5D5L 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.

Bibliographical note

© Author(s) (or their employer(s)) 2021.

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