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人们的机动性、功能独立性和生活质量