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: 10543432
• 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 2024-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10543432
• 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; Flexor; Functional disorder; Gait; Gastrocnemius Muscle; Goals; Impairment; Individual; Intermittent Claudication; Intervention; Interview; Ischemia; 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; Treadmill Tests; United States Department of Veterans Affairs; Vascularization; Veterans; Visual; Walking; Work; absorption; acceptability and feasibility; analog; 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; walker

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流动性、功能独立性和生活质量 患有外周动脉疾病（PAD）的患者可以使用专门设计的辅助鞋。焊盘是一个 全身动脉粥样硬化的表现，导致腿部动脉阻塞，导致血液不足 流向下肢。 PAD 引起的肢体缺血是血管内最常见的治疗疾病 奥马哈退伍军人事务医疗中心的外科服务。 PAD 也占运营量的三分之一 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 常见的 PAD 症状。患有 PAD 的跛行患者行走速度较慢，生活质量下降并丧失能力 独立进行日常生活活动。我们已经发现了脚踝的持续缺陷 跖屈肌在行走过程中有效地推出。目前，对于患有以下疾病的患者来说，存在着严重的治疗缺口： 疾病表现并不需要手术治疗，但希望恢复功能的人 独立性和行走能力。专门设计的辅助鞋（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出力减少的人群的推出力 容量，但这尚未经过测试。这项工作建议评估患者在使用方面的偏好 辅助鞋以及这些鞋是否可以改善跛行 PAD 患者的行走能力。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、行走的轻松性和可行性而获得积极的结果。这些假设将被检验 通过以下三个具体目标： 目标 1：确定步行表现的急剧改善（跛行步行距离、 PAD 患者在使用其标准时的垂直地面反作用力和肌肉氧合） 鞋子与辅助鞋。 目标 2：确定受试者报告的对辅助鞋的偏好。 目标 3：确定身体活动、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后。 目标 1 和 2 将招募 20 名 PAD 患者。对于目标 1，每位受试者将在压力下行走 仪器化跑步机，同时使用近红外光谱传感器进行渐进式跑步机测试 每种鞋的小腿状况：i) 标准、ii) CF 和 iii) SL。步行表现将通过以下方面进行评估 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 对这三种鞋进行比较。目标 2 将主要关注主题的定性测量 据报告倾向于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。目标 1 和目标 2 中的 5 名患者对 CL 感到满意，另外 5 名患者对目标 1 和 2 感到满意 对 SL 感到满意，将被招募用于目标 3。患者将穿着他们选择的辅助鞋进行常规训练 每日使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，我们的目标是 证明 PAD 患者使用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。