Characterization and clinical trial of a Variable Friction Shoe, a new paradigm of reduced-constraint locomotor therapy for people exhibiting foot drop due to stroke

可变摩擦鞋的表征和临床试验，这是一种针对因中风而出现足下垂的患者的减少约束运动疗法的新范例

• 批准号: 10720578
• 负责人: Elliot Wright Hawkes
• 金额: $ 56.27万
• 依托单位: UNIVERSITY OF CALIFORNIA SANTA BARBARA
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10720578
• 关键词: Address; Adoption; Affect; Age; American; Ankle; Auditory; Biofeedback; Characteristics; Chronic; Clinical Trials; Coupled; Custom; Data; Devices; Effectiveness; Equilibrium; Exhibits; Feedback; Floor; Foot-drop; Foundations; Friction; Future; Gait; Gait speed; Hip region structure; Home; Home Ranges; Impairment; Individual; Joints; Manuals; Measurement; Measures; Mechanics; Medical Care Costs; Medical Device; Minor; Modeling; Monitor; Motion; Movement; Muscle; Musculoskeletal; Nature; Orthotic Devices; Participant; Patients; Performance; Persons; Phase; Positioning Attribute; Recovery; Rehabilitation therapy; Risk; Risk Factors; Series; Shoes; Stress; Stroke; Structure; Surface; Testing; Therapeutic; Therapeutic Effect; Toes; Torque; Training; United States; Volition; Walking; Weight; Work; actigraphy; aging population; ankle joint; arm; chronic stroke; clinical efficacy; cost; fear of falling; foot; functional electrical stimulation; hazard; improved; kinematics; neglect; neuromuscular system; peroneal nerve; post stroke; prevent; primary outcome; responders and non-responders; sound; stem; stroke incidence; stroke survivor; therapy outcome; tool; walking speed

Project Summary More than one million Americans present with foot drop after stroke and often develop compensatory strategies to avoid scuffing the foot. Current treatment for foot drop addresses the hazard of tripping by applying non- volitional torques to the ankle to prevent the foot from plantarflexing. The two most common such devices are the Ankle Foot Orthosis (AFO) and Functional Electrical Stimulation (FES), which both provide well-documented orthotic effects to help users walk while the device is worn. However, therapeutic effects are limited, and users rarely improve enough to cease needing their device. Accordingly, here we propose an alternative strategy that addresses the hazard of tripping even while allowing full volitional control of the ankle: an inexpensive Variable Friction (VF) shoe. Its outsole is high-friction during the stance phase of gait and low friction during swing; further, it produces a “click” when a scuff occurs. Evidence suggests that such feedback can enhance therapeutic outcomes. Our preliminary data suggests that the VF shoe is effective at increasing gait speed immediately (orthotic effect) and after long term use, even when the shoe is removed (therapeutic effect). Our central hypothesis is that allowing volitional motion of the ankle while mitigating the hazard of tripping coupled with gait-phased auditory biofeedback will result in improved gait for subjects with drop foot. Specifically, we hypothesize that the VF shoe will show significantly greater therapeutic effects than an AFO, yet maintain the desirable orthotic effect of the AFO. We arrange our work in two Aims. Specific Aim 1: Characterize the scuff-force reduction of the VF shoe over the lifetime of use. Critical to understanding the effects of the VF shoe is a characterization of the level of scuff-force reduction. Specific Aim 2: Evaluate the effects of the VF shoe on gait in individuals with chronic stroke and drop foot. During each 12-week phase of an AB-BA clinical trial, participants will walk for at least 30-45 minutes per day for at least 5 days per week at home. We expect that this work will validate our VF shoe as a tool for improving gait after stroke and will introduce a new paradigm for drop foot therapy: fully volitional ankle control while mitigating tripping. The results will lay the foundation for a future pivotal device trial on the VF shoe to assess clinical efficacy. Importantly, the VF shoe is simple, low-cost and easy-to-use, making wide-ranging home-based adoption feasible.

项目摘要 超过一百万的美国人在中风后出现足下垂，并经常制定补偿策略 以避免刮伤脚部。目前治疗足下垂的方法是通过应用非 对踝关节施加意志扭矩以防止足部跖屈。两种最常见的此类设备是 踝足矫形器（AFO）和功能性电刺激（FES），两者都提供了良好的记录 矫正效果，以帮助用户在佩戴设备时行走。然而，治疗效果是有限的，使用者 很少能改善到不再需要他们的设备。 因此，在这里，我们提出了一种替代策略，即使允许 完全自主控制脚踝：一种廉价的可变摩擦力（VF）鞋。其外底具有高摩擦力， 步态的站立阶段和挥杆过程中的低摩擦;此外，当发生磨损时，它会产生“咔嗒”声。证据 表明这种反馈可以提高治疗效果。我们的初步数据表明VF鞋 在立即增加步态速度（矫正效果）和长期使用后，即使当鞋 治疗效果（therapeutic effect） 我们的中心假设是，允许踝关节的自主运动，同时减轻绊倒的危险， 与步态相控的听觉生物反馈将导致改善的步态与垂足的主体。我们特别 假设VF鞋将显示出比AFO显著更大的治疗效果，但仍保持 AFO的矫形效果理想。我们的工作有两个目标。 具体目标1：表征VF鞋在使用寿命内的磨损力降低。的关键 理解VF鞋的效果是磨损力减少水平的表征。 具体目标2：评价VF鞋对慢性卒中和跌倒患者步态的影响 脚在AB-BA临床试验的每个12周阶段，参与者将步行至少30-45分钟， 每周至少5天在家。 我们希望这项工作将验证我们的VF鞋作为改善中风后步态的工具，并将介绍一种 垂足治疗的新范例：完全自主的踝关节控制，同时减轻绊倒。结果将奠定 为VF鞋未来关键器械试验评估临床疗效奠定了基础。重要的是，VF鞋款 简单、低成本和易于使用，使广泛的家庭采用成为可能。