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

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

SUBMITTER: Vanicek N 

PROVIDER: S-EPMC7978257 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature