Improving walking in peripheral artery disease using specially designed assistive shoes

该项目的长期目标是提高移动性、功能独立性和生活质量 外周动脉疾病(PAD)患者使用专门设计的辅助鞋。PAD是一种 系统性动脉粥样硬化的表现，导致腿部动脉阻塞，导致血液不足 流向四肢。PAD所致的肢体缺血是血管内治疗最常见的疾病。 奥马哈退伍军人事务医疗中心的外科服务。PAD也占到了三分之一的业务 在退伍军人管理局全国范围内演出。被称为间歇性跛行的步行引起的肌肉疼痛是最严重的 常见的垫子症状。患有PAD的患者行走速度变慢，生活质量下降，失去 在日常生活活动中的独立性。我们已经确定了脚踝的持续性缺陷 在行走过程中，足底屈肌可以有效地向外推。目前，患有以下疾病的患者存在严重的治疗缺口 疾病表现不需要手术治疗，但希望恢复功能的患者 独立和行走能力。特殊设计的辅助鞋(碳纤维：CF；弹力：SL) 特定的机械性能可以吸收和释放能量，已被证明可以提高推出效率 在步行者和跑步者中。这些鞋可能会改善脚踝推离减少的人群的推送 容量，但这还没有经过测试。这项工作建议从以下方面评估患者的偏好 辅助鞋，以及这些鞋是否改善了患有PAD的跛行患者的行走能力。我们 假设辅助鞋(CF和SL)将改善PAD AS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性鞋子的偏好(CF和 SL)将基于舒适性、疲劳性、步行便捷性和可行性进行积极评价。这些假说将得到检验。 通过以下三个具体目标： 目标1：确定行走能力的显著改善(跛行行走距离， PAD患者使用标准时的垂直地面反作用力和肌肉氧合 鞋和辅助鞋。 目的2：确定受试者对辅助鞋的偏好。 目标3：确定体力活动、生活质量和步行距离的逐步改善 在进行了三个月的辅助性鞋子干预后。 20名PAD患者将被招募参加目标1和目标2。对于目标1，每个受试者将在压力下行走 仪表式跑步机，同时在近红外光谱传感器打开的情况下执行渐进跑步机测试 每种鞋况的小腿：i)标准、ii)CF和iii)SL。行走能力将在以下方面进行评估 跛行行走距离、垂直地面反作用力和肌肉氧合。所有结果都将是 对比了这三种类型的鞋子。目标2将主要集中于对受试者的定性测量 报告偏好，以确定辅助鞋是否可行，以供PAD患者使用。视觉模拟 将使用量表、感觉到的劳累程度和访谈来评估舒适度、疲劳感、强度和可行性。 在AIM 1的每种情况下，来自AIM 1和AIM 2的5名患者对CL满意，另外5名患者 对SL满意的，将被招募到AIM 3。患者将穿他们选择的辅助鞋进行常规 每日服用三个月，作为保守干预。体力活动、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。总体而言，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。结果将支持一个完整的临床 试验，并指导必要的干预时间和潜在的康复建议。

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.