Matthew G King, Ryan Hon, Eliza Roughead, Joanne L Kemp, Tania Pizzari, Justin Wong, Hylton B Menz, Nicholas F Taylor, Anton Harms, Jodie A McClelland, Adam I Semciw
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Prefabricated contoured foot orthoses have shown promise in improving hip muscle efficiency during walking in laboratory settings, but their real-world feasibility and efficacy remain uncertain.</p><p><strong>Objective: </strong>The aim of this study was to assess the feasibility of conducting a fully powered randomised controlled trial (RCT) to evaluate the effectiveness of prefabricated contoured foot orthoses, prescribed via telehealth, in people with hip OA.</p><p><strong>Methods: </strong>This feasibility trial randomised 27 participants with hip OA into two groups: prefabricated contoured foot orthoses or flat shoe inserts. Feasibility outcomes were assessed, including recruitment rate, adherence, logbook completion, and dropout rate. 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引用次数: 0
摘要
背景：髋关节骨性关节炎（OA）是一种普遍存在且负担沉重的疾病，会导致生活质量下降并带来巨大的经济负担。鼓励体育锻炼，尤其是步行，对于治疗 OA 至关重要，但许多髋关节 OA 患者无法达到建议的活动量。在实验室环境中，预制的轮廓足部矫形器在改善行走过程中髋部肌肉的效率方面显示出了前景，但其在现实世界中的可行性和有效性仍不确定：本研究旨在评估开展一项完全有效的随机对照试验（RCT）的可行性，以评估通过远程医疗开具处方的预制轮廓足部矫形器对髋关节 OA 患者的有效性：这项可行性试验将 27 名髋关节 OA 患者随机分为两组：预制轮廓足部矫形器或平底鞋垫。对可行性结果进行了评估，包括招募率、依从性、日志完成情况和退出率。作为次要结果，还收集了患者报告的结果和加速度计测量的体力活动：虽然招募率较低（0.88 人/周），但干预的坚持率（59%）、日志完成率（93%）和辍学率（7%）均达到或超过了我们预先设定的可行性参数。参与者认为干预是可以接受的，并证明了干预的实用性和轻微的不良反应。初步疗效测试表明，预制足部轮廓矫形器对体力活动有积极影响（调整后的平均差异=2590 [260 至 4920] 步/天），对髋关节相关生活质量和疼痛的影响相当：本试验支持继续进行一项完全有效的 RCT，以评估远程治疗预制轮廓足部矫形器对髋关节 OA 患者体力活动的影响：研究注册号：美国国立卫生研究院试验注册表（NCT05138380）。
Prefabricated contoured foot orthoses to reduce pain and increase physical activity in people with hip osteoarthritis: A randomised feasibility trial.
Background: Hip osteoarthritis (OA) is a prevalent and burdensome condition that leads to impaired quality of life and a substantial economic burden. Encouraging physical activity, particularly walking, is crucial for OA management, but many individuals with hip OA fail to meet recommended activity levels. Prefabricated contoured foot orthoses have shown promise in improving hip muscle efficiency during walking in laboratory settings, but their real-world feasibility and efficacy remain uncertain.
Objective: The aim of this study was to assess the feasibility of conducting a fully powered randomised controlled trial (RCT) to evaluate the effectiveness of prefabricated contoured foot orthoses, prescribed via telehealth, in people with hip OA.
Methods: This feasibility trial randomised 27 participants with hip OA into two groups: prefabricated contoured foot orthoses or flat shoe inserts. Feasibility outcomes were assessed, including recruitment rate, adherence, logbook completion, and dropout rate. Patient-reported outcomes and accelerometer-measured physical activity were collected as secondary outcomes.
Results: While the recruitment rate was low (0.88 people/week), adherence to the intervention (59%), logbook completion (93%), and dropout rates (7%) met or exceeded our predefined feasibility parameters. Participants found the intervention acceptable, and practicality was demonstrated with minor adverse events. Preliminary efficacy testing indicated that prefabricated contoured foot orthoses positively affected physical activity (adjusted mean difference = 2590 [260 to 4920] steps/day), with comparable outcomes for hip-related quality of life and pain.
Conclusion: This trial supports proceeding to a fully powered RCT to assess the effect of teleheath prescribed prefabricated contoured foot orthoses on physical activity in people with hip OA.
Study registration number: National Institutes of Health Trial Registry (NCT05138380).
期刊介绍：
Physiotherapy Research International is an international peer reviewed journal dedicated to the exchange of knowledge that is directly relevant to specialist areas of physiotherapy theory, practice, and research. Our aim is to promote a high level of scholarship and build on the current evidence base to inform the advancement of the physiotherapy profession. We publish original research on a wide range of topics e.g. Primary research testing new physiotherapy treatments; methodological research; measurement and outcome research and qualitative research of interest to researchers, clinicians and educators. Further, we aim to publish high quality papers that represent the range of cultures and settings where physiotherapy services are delivered. We attract a wide readership from physiotherapists and others working in diverse clinical and academic settings. We aim to promote an international debate amongst the profession about current best evidence based practice. Papers are directed primarily towards the physiotherapy profession, but can be relevant to a wide range of professional groups. The growth of interdisciplinary research is also key to our aims and scope, and we encourage relevant submissions from other professional groups. The journal actively encourages submissions which utilise a breadth of different methodologies and research designs to facilitate addressing key questions related to the physiotherapy practice. PRI seeks to encourage good quality topical debates on a range of relevant issues and promote critical reflection on decision making and implementation of physiotherapy interventions.
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