ORCID Profile
0000-0001-5124-138X
Current Organisation
University of York
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Publisher: BMJ
Date: 09-2019
DOI: 10.1136/BMJOPEN-2019-032924
Abstract: The majority of older patients with a transtibial utation are prescribed a standard (more rigid, not self-aligning) prosthesis. These are mostly suitable for level walking, and cannot adjust to different sloped surfaces. This makes walking more difficult and less energy efficient, possibly leading to longer term disuse. A Cochrane Review concluded that there was insufficient evidence to recommend any in idual type of prosthetic ankle-foot mechanism. This trial will establish the feasibility of conducting a large-scale trial to assess the effectiveness and cost-effectiveness of a self-aligning prosthesis for older patients with vascular-related utations and other health issues compared with a standard prosthesis. This feasibility trial is a pragmatic, parallel group, randomised controlled trial (RCT) comparing standard treatment with a more rigid prosthesis versus a self-aligning prosthesis. The target s le size is 90 patients, who are aged 50 years and over, and have a transtibial utation, where utation aetiology is mostly vascular-related or non-traumatic. Feasibility will be measured by consent and retention rates, a plausible future s le size over a 24-month recruitment period and completeness of outcome measures. Qualitative interviews will be carried out with trial participants to explore issues around study processes and acceptability of the intervention. Focus groups with staff at prosthetics centres will explore barriers to successful delivery of the trial. Findings from the qualitative work will be integrated with the feasibility trial outcomes in order to inform the design of a full-scale RCT. Ethical approval was granted by Yorkshire and the Humber—Leeds West Research Ethics Committee on 4 May 2018. The findings will be disseminated via peer-reviewed research publications, articles in relevant newsletters, presentations at relevant conferences and the patient advisory group. ISRCTN15043643 .
Publisher: Wiley
Date: 06-08-2019
DOI: 10.1002/EHF2.12498
Publisher: BMJ
Date: 03-2021
DOI: 10.1136/BMJOPEN-2020-045195
Abstract: 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. Multicentre parallel group feasibility RCT. Five prosthetics centres in England recruiting from July 2018 to August 2019. Adults aged ≥50 years with a vascular-related or non-traumatic transtibial utation for 1 year or longer, categorised as having ‘limited community mobility’ and using a non-self-aligning ankle-foot. Participants were randomised into one of two groups for 12 weeks: self-aligning prosthetic ankle-foot or existing non-self-aligning prosthetic ankle-foot. 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. 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. This feasibility trial recruited and retained participants who were categorised as having ‘limited community mobility’ following a transtibial utation. 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. ISRCTN15043643 .
Location: United Kingdom of Great Britain and Northern Ireland
No related grants have been discovered for Kerry Jane Bell.