Measurement and classification of vertical and shear forces and distributions in

垂直力和剪切力及其分布的测量和分类

• 批准号: 7980189
• 负责人: Scott Barnes
• 金额: $ 34.35万
• 依托单位: BERTEC CORPORATION
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-15 至 2013-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7980189
• 关键词: Academia; Accounting; Address; Affect; Age; Amputation; Area; Biomechanics; Blindness; Centers for Disease Control and Prevention (U.S.); Classification; Clinic; Clinical; Clinical Trials; Communities; Complication; Complications of Diabetes Mellitus; Computer software; Data; Devices; Diabetes Mellitus; Diabetic Foot; Diabetic Foot Ulcer; Diagnosis; Engineering; Etiology; Evaluation; Event; Film; Finite Element Analysis; Foot Ulcer; Foundations; Goals; Health; Heart Diseases; Individual; Kidney Failure; Lead; Limb structure; Location; Lower Extremity; Maps; Marketing; Measurement; Measures; Metric; Modeling; Patients; Phase; Physicians; Plantar Ulcers; Play; Population; Positioning Attribute; Preventive Medicine; Questionnaires; Reaction; Reporting; Research; Research Personnel; Resolution; Role; Science; Solutions; Stress; Surface; System; Technology; Testing; Time; Ulcer; United States; Universities; Walking; base; cost; cost effective; data acquisition; diabetic; diabetic patient; digital; foot; foot sole; human subject; improved; innovation; insight; instrument; interest; lifetime risk; meetings; member; pressure; prototype; research facility; shear stress; tool; tool development

DESCRIPTION (provided by applicant): Foot ulcers are a prevalent complication in the diabetic population, and despite that, the exact causation of plantar ulcers is still unknown. Research suggests that vertical pressure and horizontal shear play an integral role, but the pressure and shear distributions must be precisely measured on the entire plantar surface. Unfortunately, only pressure distribution measurement systems are commercially available. Several shear stress distribution measurement systems have been developed in universities in the past, but the systems are limited in their resolution, accuracy, and size. To address this need, Bertec Corporation is proposing to collaborate with Innovative Scientific Solutions Inc. and the Cleveland Clinic Foundation to develop a measurement tool where the continuous distributions of pressure and shear over the entire plantar foot can be quantified for approximately the cost of existing commercially available tools that are capable of only measuring pressure. This tool will be a force plate developed by Bertec with an elastic surface stress sensitive film (S3F) coating the top developed by ISSI. The device will be tested with diabetics and age-matched controls at the Cleveland Clinic in order to better refine the system and its software. It will be capable of measuring the ground reaction forces and the continuous pressure and shear distributions as a subject walks across the plate. The final product will be of great interest to biomechanists, podiatrists, physical therapists, and doctors specializing in the treatment of diabetes and diabetic foot complications. But in order to reach that goal, the following specific aims must be accomplished: Aim 1, Phase I) Integrate an elastic polymeric film sensitive to pressure and shear with a 6-component force plate in order to obtain a prototype instrument that will yield ground reaction forces plus a true pressure and shear deformation distribution in the polymeric film, due to plantar loading; Aim 2, Phase II) Capture precise foot landmark positions on the prototype product of Aim 1, so that the measured quantities can be accurately mapped to the physical location on the foot; Aim 3, Phase II) Utilizing the finite element analysis model, as independently established by Innovative Science Solutions Inc., for the surface stress sensitive film, and the synchronously measured shear forces from the force plate, convert the shear deformation distribution of the prototype product to shear stress distribution. Then integrate this analysis module into Bertec's digital data acquisition software allowing auto-calculation of shear stresses; Aim 4, Phase II) Incorporate the pressure deformation distribution and foot marker position data from Phase I and Aim 2 into the data acquisition software. Using the finite element analysis model and the synchronously measured vertical force by the force plate, calibrate the pressure deformation model to auto-calculate true pressure distribution; and Aim 5, Phase II) Evaluate the clinical utility of the prototype system, including the acquisition software measuring shear stress and pressure distribution acting upon the plantar foot, from a functional as well as a research point of view through clinical trials of patients with and without diabetes. PUBLIC HEALTH RELEVANCE: Nearly 10% of the US population has diabetes, and foot ulcers are one of the most common complications - often resulting in amputation. Pressure and shear stress acting on the sole of the foot may be responsible for ulcer formation, but no tool is commercially available that can measure pressure and shear distributions. Bertec's S3F-force plate system is capable of measuring and displaying the distributions and forces acting upon sole of the diabetic's foot.

描述（由申请人提供）：足部溃疡是糖尿病人群中的一种常见并发症，尽管如此，足底溃疡的确切原因仍然未知。研究表明，垂直压力和水平剪切力起着不可或缺的作用，但压力和剪切力分布必须在整个足底表面上精确测量。不幸的是，只有压力分布测量系统是商业上可获得的。在过去的大学里，已经开发了几种剪切应力分布测量系统，但是这些系统在分辨率、精度和尺寸方面受到限制。为了满足这一需求，Bertec公司提议与创新科学解决方案公司合作。和Cleveland Clinic Foundation开发了一种测量工具，其中压力和剪切力在整个足底上的连续分布可以被量化，其成本大约是现有的仅能够测量压力的市售工具的成本。该工具将是由Bertec开发的测力板，其顶部涂覆有由ISSI开发的弹性表面应力敏感膜（S3 F）。该设备将在克利夫兰诊所与糖尿病患者和年龄匹配的对照组进行测试，以更好地完善系统及其软件。它将能够测量地面反作用力和连续的压力和剪切分布作为一个主题走过板。最终产品将引起生物力学家，足科医生，物理治疗师和专门治疗糖尿病和糖尿病足并发症的医生的极大兴趣。目标1，阶段I）将对压力和剪切敏感的弹性聚合物膜与6分量测力板结合，以获得原型仪器，该原型仪器将产生地面反作用力加上由于足底负荷而在聚合物膜中的真实压力和剪切变形分布; Aim 2，Phase II）在Aim 1的原型产品上捕获精确的足部标志位置，以便测量的量可以准确地映射到足部的物理位置; Aim 3，Phase II）利用由Innovative Science Solutions Inc.独立建立的有限元分析模型，对于表面应力敏感膜，与测力板同步测得的剪切力，将原型产品的剪切变形分布转换为剪切应力分布。然后将该分析模块集成到Bertec的数字数据采集软件中，允许自动计算剪切应力;目标4，第二阶段）将来自第一阶段和目标2的压力变形分布和足部标记位置数据集成到数据采集软件中。利用有限元分析模型和测力板同步测得的竖向力，标定压力变形模型，自动计算真实压力分布;和目标5，阶段II）评估原型系统的临床效用，包括测量作用在足底脚上的剪切应力和压力分布的采集软件，从功能和研究的角度来看，通过对糖尿病患者和非糖尿病患者的临床试验。公共卫生关系：近10%的美国人口患有糖尿病，足部溃疡是最常见的并发症之一-通常导致截肢。作用于足底的压力和剪切应力可能是溃疡形成的原因，但是没有商业上可获得的工具可以测量压力和剪切分布。Bertec的S3 F测力板系统能够测量和显示作用在糖尿病患者脚底的分布和力。