Discipline of Physiotherapy, La Trobe University, Melbourne, Victoria, Australia.
La Trobe Sport and Exercise Medicine Research Centre, La Trobe University, Melbourne, Victoria, Australia.
Physiother Res Int. 2024 Oct;29(4):e2118. doi: 10.1002/pri.2118.
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.
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.
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.
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.
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.
National Institutes of Health Trial Registry (NCT05138380).
髋骨关节炎（OA）是一种普遍存在且负担沉重的疾病，会导致生活质量受损和巨大的经济负担。鼓励身体活动，尤其是行走，对于 OA 的管理至关重要，但许多髋骨 OA 患者未能达到推荐的活动水平。预制的有曲度的足部矫形器已被证明可以在实验室环境中提高行走时髋部肌肉的效率，但它们在现实世界中的可行性和疗效仍不确定。
本研究旨在评估进行充分-powered 随机对照试验（RCT）以评估通过远程医疗处方预制有曲度的足部矫形器对髋骨 OA 患者有效性的可行性。
这项可行性试验将 27 名髋骨 OA 患者随机分为两组：预制有曲度的足部矫形器或平底鞋衬垫。评估了可行性结果，包括招募率、依从性、日志完成情况和辍学率。还收集了患者报告的结果和加速度计测量的身体活动作为次要结果。
虽然招募率较低（0.88 人/周），但干预措施的依从性（59%）、日志完成率（93%）和辍学率（7%）符合或超过了我们预先设定的可行性参数。参与者认为该干预措施可接受，并且仅出现轻微不良事件，表明具有实用性。初步疗效测试表明，预制有曲度的足部矫形器对身体活动有积极影响（调整后的平均差异为 2590 [260 至 4920] 步/天），并且对髋部相关生活质量和疼痛也有类似的效果。
这项试验支持进行充分-powered RCT，以评估远程医疗处方预制有曲度的足部矫形器对髋骨 OA 患者身体活动的影响。
美国国立卫生研究院试验注册处（NCT05138380）。
