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.
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.
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.
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.
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.
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Department of Health Sciences, University of York, York
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.