Improving walking in peripheral artery disease using specially designed assistive shoes

使用专门设计的辅助鞋改善外周动脉疾病患者的行走

• 批准号: 10368277
• 负责人: Sara A Myers
• 金额: --
• 依托单位: OMAHA VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-11-01 至 2023-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10368277
• 关键词: Accelerometer; Activities of Daily Living; Acute; Adopted; Ankle; Arteries; Atherosclerosis; Award; Biomechanics; Biopsy; Blood Vessels; Blood flow; Cardiovascular Diseases; Clinical Trials; Conduct Clinical Trials; Data; Diagnosis; Disease; Engineering; Exercise Therapy; Exertion; Fatigue; Functional disorder; Gait; Gastrocnemius Muscle; Goals; Impairment; Individual; Intermittent Claudication; Intervention; Interview; Lead; Leg; Length; Lower Extremity; Measurement; Measures; Medical center; Morbidity - disease rate; Muscle; Myalgia; Myopathy; Near-Infrared Spectroscopy; Orthotic Devices; Outcome; Pain; Pain in lower limb; Patient Care; Patient Preferences; Patients; Performance; Peripheral arterial disease; Physical activity; Pilot Projects; Population; Positioning Attribute; Procedures; Protocols documentation; Quality of life; Questionnaires; Reaction; Recommendation; Rehabilitation therapy; Reporting; Self-Help Devices; Shoes; Specialist; Surgeon; Symptoms; Testing; Time; Treadmill Tests; United States Department of Veterans Affairs; Veterans; Visual; Walkers; Walking; Work; acceptability and feasibility; analog; base; carbon fiber; cardiovascular risk factor; claudication; design; exoskeleton; foot; functional independence; implementation barriers; improved; improved mobility; instrument; limb ischemia; mechanical properties; mortality; mortality risk; novel; novel therapeutic intervention; operation; preference; pressure; recruit; sedentary; sensor; standard care; surgical service; treadmill

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.

该项目的长期目标是提高移动性，功能独立性和生活质量 使用特殊设计的辅助鞋患有外周动脉疾病（PAD）的患者。垫是一个 全身性动脉粥样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。垫子还占操作的三分之一 在弗吉尼亚州在全国范围内表演。行走引起的肌肉疼痛称为间歇性lau不平是最大的 普通垫症状。用垫子步行较慢，降低生活质量并损失的患者 独立于日常生活的活动。我们已经确定了脚踝的一致缺陷 植物的植物可以在步行过程中有效推开。目前，对于患者有关键的治疗差距 疾病表现不保证一种手术方法，而是希望恢复其功能 独立和步行能力。特殊设计的辅助鞋（碳纤维：CF；弹簧加载：SL） 已经证明要吸收和释放能量的特定机械性能促进推断效率 在步行者和跑步者中。这些鞋可能会导致人群的推断，而脚踝推断减少了 能力，但这尚未进行测试。这项工作建议根据使用的评估患者偏好 辅助鞋以及这些鞋子是否可以改善用垫子的患者的行走性能。我们 假设辅助鞋（CF和SL）将导致患有PAD患者的步行性能提高 与标准鞋相比。我们还假设主题报告了辅助鞋的偏爱（CF和 SL）将基于舒适性，疲劳，易于步行和可行性而为积极。这些假设将进行测试 通过以下三个特定目标： AIM 1：确定步行表现的急性改善（Claudication步行距离， 使用标准的患者的垂直地面反作用力和肌肉氧合） 鞋子与辅助鞋。 目标2：确定辅助鞋的主题偏好。 目标3：确定体育锻炼，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。 将为AIM 1和2招募二十名PAD患者。对于AIM 1，每个受试者都会在压力下行走 仪器跑步机在执行渐进式跑步机测试时，并在近红外光谱传感器上进行 每种鞋子条件的小腿：i）标准，ii）CF和iii）sl。步行性能将以术语进行评估 laud缩距离，垂直地面反作用力和肌肉氧合。所有结果将是 在这三种类型的鞋子中进行了比较。 AIM 2主要专注于主题的定性测量 报告的偏爱是确定辅助鞋对于使用PAD的患者是否可行。视觉分析 尺度，感知劳动的速度和访谈将用于评估舒适性，疲劳，强度和可行性 在AIM 1的每个条件之后 对SL感到满意，将招募AIM 3。患者将穿自己选择的辅助鞋来定期 每天使用三个月作为保守的干预。体育锻炼，生活质量和步行距离 将在干预开始之前和三个月干预后进行评估。总体而言，我们的目标将 在患者使用PAD的患者中证明辅助鞋的可行性和可接受性。结果将支持完整的临床 试验，并指导必要的干预长度和潜在的康复建议。