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 中风后有超过一百万的美国人，脚步下降，经常制定补偿策略 避免划伤脚。当前的脚滴处理解决了通过应用非 - 自愿到脚踝的扭矩，以防止脚倾斜。这两个最常见的设备是 脚踝矫形器（AFO）和功能性电刺激（FES），两者都提供了有据可查的文献 矫形效果可帮助用户在设备佩戴时行走。但是，治疗作用有限，用户 很少有进步足以停止需要他们的设备。 据此，我们提出了一种替代策略，即使允许 踝关节的全向控制：廉价的可变摩擦（VF）鞋。它的外底在 挥杆过程中步态和低摩擦的立场阶段；此外，当发生划痕时，它会产生“单击”。证据 表明这种反馈可以增强治疗结果。我们的初步数据表明VF鞋 即使鞋子为 删除（治疗效果）。 我们的中心假设是，允许脚踝的自愿运动，同时减轻绊倒的危险 借助步态，听觉后反馈将导致步态的步态改善。具体来说，我们 假设VF鞋会比AFO显示出更大的治疗作用，但保持 AFO的理想矫形作用。我们将工作安排为两个目标。 特定目标1：表征使用寿命在使用的一生中，VF鞋的划伤降低。对 了解VF鞋的效果是对磨损降低水平的表征。 特定目的2：评估VF鞋对聚集的慢性中风和滴落的影响 脚。在AB-BA临床试验的每个12周阶段，参与者每次行走至少30-45分钟 每周至少在家中至少5天。 我们希望这项工作将验证我们的VF鞋作为中风后改善聚集的工具，并将引入一个 用于降水疗法的新范式：减轻绊倒的同时，完全自愿的脚踝控制。结果将放置 在VF鞋上进行未来关键设备试验的基础，以评估临床效率。重要的是，VF鞋是 简单，低成本且易于使用，使广泛的基于家庭的采用可行。