Effectiveness of supervised versus self-directed rehabilitation for adults aged 50 years and over with ankle fractures: protocol for the AFTER trial.

IF 2.8 Q1 ORTHOPEDICS Bone & Joint Open Pub Date : 2024-06-20 DOI:10.1302/2633-1462.56.BJO-2023-0183
David J Keene, Juul Achten, Colin Forde, May E Png, Richard Grant, Kylea Draper, Duncan Appelbe, Elizabeth Tutton, Nicholas Peckham, Susan J Dutton, Sarah E Lamb, Matthew L Costa
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Abstract

Aims: Ankle fractures are common, mainly affecting adults aged 50 years and over. To aid recovery, some patients are referred to physiotherapy, but referral patterns vary, likely due to uncertainty about the effectiveness of this supervised rehabilitation approach. To inform clinical practice, this study will evaluate the effectiveness of supervised versus self-directed rehabilitation in improving ankle function for older adults with ankle fractures.

Methods: This will be a multicentre, parallel-group, individually randomized controlled superiority trial. We aim to recruit 344 participants aged 50 years and older with an ankle fracture treated surgically or non-surgically from at least 20 NHS hospitals. Participants will be randomized 1:1 using a web-based service to supervised rehabilitation (four to six one-to-one physiotherapy sessions of tailored advice and prescribed home exercise over three months), or self-directed rehabilitation (provision of advice and exercise materials that participants will use to manage their recovery independently). The primary outcome is participant-reported ankle-related symptoms and function six months after randomization, measured by the Olerud and Molander Ankle Score. Secondary outcomes at two, four, and six months measure health-related quality of life, pain, physical function, self-efficacy, exercise adherence, complications, and resource use. Due to the nature of the interventions, participants and intervention providers will be unblinded to treatment allocation.

Conclusion: This study will assess whether supervised rehabilitation is more effective than self-directed rehabilitation for adults aged 50 years and older after ankle fracture. The results will provide evidence to guide clinical practice. At the time of submission, the trial is currently completing recruitment, and follow-up will be completed in 2024.

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针对 50 岁及以上踝关节骨折成人的监督康复与自主康复的有效性:AFTER 试验方案。
目的:踝关节骨折很常见,主要影响 50 岁及以上的成年人。为了帮助患者康复,一些患者会被转介到物理治疗机构,但转介模式各不相同,这可能是由于这种有监督的康复方法的效果不确定。为了给临床实践提供参考,本研究将评估监督康复与自主康复在改善踝关节骨折老年人踝关节功能方面的效果:这将是一项多中心、平行分组、单独随机对照的优越性试验。我们的目标是从至少 20 家英国国家医疗服务体系医院中招募 344 名年龄在 50 岁及以上、接受过手术或非手术治疗的踝关节骨折患者。参与者将通过网络服务以 1:1 的比例随机接受监督康复(在三个月内接受四到六次一对一的物理治疗,提供量身定制的建议和规定的家庭锻炼)或自主康复(提供建议和锻炼材料,参与者将利用这些材料独立管理自己的康复)。主要研究结果是随机分组 6 个月后参与者报告的踝关节相关症状和功能,以 Olerud 和 Molander 踝关节评分来衡量。第二、第四和第六个月的次要结果是测量与健康相关的生活质量、疼痛、身体功能、自我效能、坚持锻炼、并发症和资源使用。由于干预的性质,参与者和干预提供者对治疗分配不设盲区:本研究将评估对于 50 岁及以上踝关节骨折后的成年人来说,指导康复是否比自我指导康复更有效。研究结果将为指导临床实践提供证据。在提交报告时,该试验正在完成招募工作,将于2024年完成随访。
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来源期刊
Bone & Joint Open
Bone & Joint Open ORTHOPEDICS-
CiteScore
5.10
自引率
0.00%
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0
审稿时长
8 weeks
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