Improving walking in peripheral artery disease using specially designed assistive shoes

该项目的长期目标是改善活动能力、功能独立性和生活质量， 使用专门设计的辅助鞋，帮助患有外周动脉疾病（PAD）的患者。垫是一个 全身动脉硬化的表现，在腿部动脉中产生阻塞，导致血液不足 流向下肢。PAD引起的肢体缺血是血管内治疗的最常见疾病， 奥马哈退伍军人事务医疗中心的外科服务。PAD也占了三分之一的业务 在弗吉尼亚州全国范围内演出步行引起的肌肉疼痛称为间歇性跛行是最 常见的PAD症状PAD患者跛行行走缓慢，生活质量下降， 独立进行日常生活活动。我们已经确定了脚踝的持续缺陷 足底屈肌在行走过程中有效地推离。目前，对于以下患者存在严重的治疗差距： 疾病表现不需要手术方法，但希望恢复功能的患者 独立性和行走能力。特别设计的辅助鞋（碳纤维：CF;弹簧加载：SL）， 吸收和释放能量的特定机械性能已被证明可提高推离效率 在步行者和跑步者中。这些鞋可能会改善踝关节蹬离减少的人群的蹬离 能力，但这还没有得到测试。这项工作提出，以评估病人的喜好，在使用 辅助鞋，以及这些鞋是否能改善PAD患者的跛行能力。我们 假设辅助鞋（CF和SL）将改善PAD患者的行走能力， 与标准鞋相比。我们还假设受试者报告了对辅助鞋的偏好（CF和 SL）将根据舒适度、疲劳度、行走方便度和可行性进行积极评价。这些假设将得到检验 通过以下三个具体目标： 目的1：确定步行能力（跛行步行距离， 垂直地面反作用力和肌肉氧合），同时使用他们的标准 鞋和辅助鞋的区别 目的2：确定受试者报告的辅助鞋的偏好。 目标3：确定体力活动、生活质量和步行距离的逐步改善 经过三个月的辅助鞋干预。 目标1和目标2将招募20名PAD患者。对于目标1，每个受试者将在压力下行走 在使用近红外光谱传感器进行渐进式跑步机测试的同时， 每个鞋条件的小腿：i）标准，ii）CF，和iii）SL。步行能力将根据以下方面进行评估： 跛行步行距离、垂直地面反作用力和肌肉氧合。所有的结果都将是 这三种鞋的对比目标2将主要侧重于受试者的定性测量 报告的偏好，以确定辅助鞋是否适合PAD患者使用。视觉模拟 量表、感知用力率和访谈将用于评估舒适度、疲劳度、强度和可行性 在目标1的每个条件之后。来自目标1和2的5名患者对CL满意，另外5名患者 对SL感到满意，将为目标3招募。患者将穿着他们选择的辅助鞋进行定期检查。 每天使用三个月作为保守干预。身体活动、生活质量和步行距离 将在干预开始前和干预三个月后进行评估。总的来说，我们的目标将 证明辅助鞋在PAD患者中的可行性和可接受性。结果将支持全面的临床 试验，并指导必要的干预长度和潜在的康复建议。

The long-term goal of this project is to improve mobility, functional independence, and quality of life in patients with peripheral artery disease (PAD) by using specially designed assistive shoes. PAD is a manifestation of systemic atherosclerosis producing blockages in the leg arteries, resulting in insufficient blood flow to the lower extremities. Limb ischemia from PAD is the most common disorder treated within the vascular surgical service of the Omaha Veterans Affairs Medical Center. PAD also accounts for one-third of the operations performed nationwide in the VA. Walking induced muscle pain known as intermittent claudication is the most common PAD symptom. Claudicating patients with PAD walk slower, have reduced quality of life and lose independence in performing activities of daily living. We have identified consistent deficits of the ankle plantarflexors to effectively push-off during walking. Currently, there is a critical treatment gap for patients whose disease presentation does not warrant an operative approach, but who desire to restore their functional independence and walking ability. Specially designed assistive shoes (carbon fiber: CF; spring-loaded: SL) with specific mechanical properties to absorb and release energy, have been shown to promote push-off efficiency in walkers and runners. These shoes may lead to improved push-off in populations with reduced ankle push-off capacity, but this has not been tested yet. This work proposes to evaluate patient preferences in terms of using assistive shoes and whether these shoes improve walking performance in claudicating patients with PAD. We hypothesize that assistive shoes (CF and SL) will lead to improved walking performance in patients with PAD as compared to standard shoes. We also hypothesize that subject reported preference of assistive shoes (CF and SL) will be positive based on comfort, fatigue, ease of walking, and feasibility. These hypotheses will be tested by the following three specific aims: Aim 1: Determine the acute improvement in walking performance (claudication walking distances, vertical ground reaction force, and muscle oxygenation) in patients with PAD while using their standard shoes versus the assistive shoes. Aim 2: Determine the subject-reported preference of assistive shoes. Aim 3: Determine the progressive improvements in physical activity, quality of life, and walking distance after a three-month assistive shoe intervention. Twenty patients with PAD will be recruited for Aims 1 and 2. For Aim 1, each subject will walk on a pressure instrumented treadmill while performing a progressive treadmill test with a near infrared spectroscopy sensor on the calf for each shoe condition: i) standard, ii) CF, and iii) SL. Walking performance will be evaluated in terms of claudication walking distances, vertical ground reaction force, and muscle oxygenation. All outcomes will be compared across these three types of shoes. Aim 2 will primarily focus on qualitative measurements of subject reported preference to identify whether assistive shoes are feasible for patients with PAD to use. Visual-analog scales, rate of perceived exertion, and interviews will be used to assess comfort, fatigue, intensity, and feasibility after each condition of Aim 1. Five patients from Aims 1 and 2 who are satisfied with CL and another five who are satisfied with SL, will be recruited for Aim 3. Patients will wear the assistive shoes of their choice for regular daily use for three months as a conservative intervention. Physical activity, quality of life, and walking distances will be assessed prior to the start of the intervention and after three months of intervention. Overall, our aims will demonstrate feasibility and acceptability of assistive shoes in patients with PAD. Results will support a full clinical trial, and guide necessary intervention length and potential rehabilitation recommendations.