Department of Sport, Health and Exercise Science, University of Hull, Hull, UK
York Trials Unit, Department of Health Sciences, University of York, York, UK.
BMJ Open. 2021 Mar 18;11(3):e045195. doi: 10.1136/bmjopen-2020-045195.
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 amputation 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 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.
ISRCTN15043643.
确定对自调整假肢踝关节与标准假肢踝关节的有效性和成本效益进行全面随机对照试验（RCT）的可行性。
多中心平行组可行性 RCT。
2018 年 7 月至 2019 年 8 月，英格兰的 5 个假肢中心参与研究，招募参与者。
年龄≥50 岁，因血管相关或非创伤性胫骨截肢 1 年或以上，被归类为“社区活动能力有限”，并使用非自调整踝关节-足假肢的成年人。
参与者随机分为两组，每组接受 12 周的治疗：自调整假肢踝关节或现有的非自调整假肢踝关节。
可行性指标：招募率、同意率和保留率；以及在多个时间点完整的问卷和临床评估数据集。使用可穿戴技术收集日常活动数据和使用定制问卷收集健康资源使用数据的可行性。
共招募了 55 名参与者（目标人数 90 人的 61%）：n=27 名自调整踝关节组，n=28 名非自调整踝关节组。51 名参与者纳入最终分析（目标人数的 71%）。最终随访时的同意率和保留率分别为 86%和 93%。平均招募率为每个站点每月 1.25 名参与者（95%CI 0.39 至 2.1）。问卷完整率范围为 89%-94%，临床评估为 92%-95%，包括活动监测数据。EQ-5D-5L 和定制资源使用问卷的平均完成率分别为 93%和 63%。
本可行性试验招募并保留了被归类为“社区活动能力有限”的胫骨截肢后患者。93%的高保留率表明试验对参与者是可接受的，且作为一项全面的 RCT 是可行的。研究结果支持对自调整假肢踝关节与标准非自调整版本的有效性和成本效益进行进一步、充分的评估，并对试验设计和实施进行一些调整。
ISRCTN85225264。
