Health Sciences
STEPFORWARD - Patient acceptability of a novel prosthetic device: A randomised feasibility study in older patients with vascular-related amputations and multi-morbidities
To address the absence of robust evidence, we set out to see if a full-scale randomised controlled trial (RCT) comparing self-aligning and non-self aligning ankle-foot prostheses would be feasible. We were able to recruit and the high retention rate of 93% indicated the trial was acceptable to participants and feasible to deliver as a full-scale RCT.
Why did we do this research?
Lower limb amputees tend to have other health problems and limited mobility even prior to amputation. There is little robust evidence to say which type of prosthetic ankle-foot mechanism is best and no standardised criteria for prescribing ankle-foot prostheses. This study set out to see if a full-scale randomised controlled trial (RCT) comparing two types of prostheses would be feasible.
What did we do?
We undertook a multicentre parallel group feasibility RCT in which participants were randomised into one of two groups for 12 weeks: self-aligning prosthetic ankle-foot or existing non-self-aligning prosthetic ankle-foot. Our outcome measures were: recruitment, consent and retention rates; and completeness of questionnaire and clinical assessment datasets across multiple time points. Also the feasibility of collecting daily activity data with wearable technology and health resource use data with a bespoke questionnaire.
Who was involved?
Adults aged 50 years or above with a transtibial amputation for one year or longer, categorised as having ‘limited community mobility’ and using a non-self-aligning ankle-foot prosthesis were eligible. We recruited from five prosthetics centres in England.
What did we find?
The high retention rate of 93% indicated the trial was acceptable to participants and feasible to deliver as a full-scale RCT. With some adjustments to the trial design and delivery, our 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.
Publications
Protocol: Mitchell N, Coleman E, Watson J, et al. Self-aligning prosthetic device for older patients with vascular-related amputations: protocol for a randomised feasibility study (the STEPFORWARD study) BMJ Open 2019;9:e032924. https://doi.org/10.1136/bmjopen-2019-032924
Results: Vanicek N, Coleman E, Watson J, et al. STEPFORWARD study: a randomised controlled feasibility trial of a self-aligning prosthetic ankle-foot for older patients with vascular-related amputations. BMJ Open. 2021 Mar 18;11(3):e045195. https://doi.org/10.1136/bmjopen-2020-045195
Qualitative: Mitchell, N., Leggett, H., Watson, J., McDaid, C. T., Barnett, C., Twiste, M., & Vanicek, N. (2024). ‘A whole different ball game’: the qualitative experience of older adults with a transtibial amputation and the use of a self-aligning prosthetic ankle-foot on the STEPFORWARD trial. Disability and Rehabilitation, 46(7), 1422–1431. https://doi.org/10.1080/09638288.2023.2199222
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Team
Department of Health Sciences, University of York, York
- Dr Natalie Vanicek (Chief Investigator), University of Hull
- Dr Fergus Jepson, Lancashire Teaching Hospitals NHS Foundation Trust
- Dr Abayomi Salawu, Hull & East Yorkshire NHS Trust
- Dr Cleveland Barnett, Nottingham Trent University
- Dr Martin Twiste, University of Salford
- Mr Dennis Harrison, Public Involvement Member
Funding
The research was funded by NIHR Research for Patient Benefit (Award ID: PB-PG-0816-20029) and a grant of £248,894.00 awarded. The project was started in April 2018 and completed in April 2020.
Study Registration
