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.

项目概要 超过一百万美国人在中风后出现足下垂，并经常制定补偿策略 为了避免擦伤足部，目前的足下垂治疗方法是通过使用非足部护理剂来解决绊倒的危险。 两种最常见的此类装置是对脚踝施加意志扭矩以防止脚跖屈。 踝足矫形器 (AFO) 和功能性电刺激 (FES)，两者都提供了详细记录 矫形效果可以帮助用户在佩戴该设备时行走，但是治疗效果有限，并且用户无法使用。 很少有足够的改进来不再需要他们的设备。 ly，在这里我们提出了一种替代策略，即使在允许的情况下也可以解决绊倒的危险 脚踝的完全意志控制：一种廉价的可变摩擦（VF）鞋，其外底在运动过程中具有高摩擦力。 步态的站立阶段和摆动过程中的低摩擦；此外，当发生磨损时，它会产生“咔哒”声。 表明这种反馈可以增强治疗效果。我们的初步数据表明 VF 鞋。 即使鞋子在长期使用后，也能立即有效提高步态速度（矫形效果） 去除（治疗效果）。 我们的中心假设是允许脚踝的意志运动，同时减轻绊倒的危险 步态阶段听觉生物反馈将改善足下垂受试者的步态。 坚持认为 VF 鞋将比 AFO 显着显示出更好的治疗效果，但仍保持 AFO 的理想矫形效果我们将我们的工作安排在两个目标上。 具体目标 1：表征 VF 鞋在使用寿命内的磨损力减少情况，这对于使用至关重要。 了解 VF 鞋的效果是磨损力降低程度的表征。 具体目标 2：评估 VF 鞋对慢性中风和跌倒患者步态的影响 在 AB-BA 临床试验的每个 12 周阶段，参与者每次至少步行 30-45 分钟。 每周至少 5 天在家。 我们期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，并将引入一种 足下垂治疗的新范例：完全自主控制脚踝，同时减少绊倒。 为未来评估 VF 鞋临床疗效的关键设备试验奠定了基础。 简单、低成本且易于使用，使得广泛的家庭采用成为可能。