Measurement of Vertical and Shear Forces and Distributions in the Diabetic Foot

糖尿病足垂直力和剪切力及其分布的测量

• 批准号: 8217446
• 负责人: Scott Barnes
• 金额: $ 10万
• 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/8217446
• 关键词: Academia; Accounting; Address; Affect; Age; Amputation; Area; Biomechanics; Blindness; Centers for Disease Control and Prevention (U.S.); 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.

描述(申请人提供)：足部溃疡是糖尿病人群中常见的并发症，尽管如此，足底溃疡的确切原因仍不清楚。研究表明，垂直压力和水平剪切起着不可或缺的作用，但必须精确测量整个足底表面的压力和剪切分布。不幸的是，只有压力分布测量系统在商业上是可用的。在过去的大学里，已经开发了几种剪应力分布测量系统，但这些系统在分辨率、精度和尺寸方面都有局限性。为了满足这一需求，Bertec Corporation提议与Innovative Science Solutions Inc.和克利夫兰临床基金会合作开发一种测量工具，该工具可以量化整个足底上的连续压力和剪切分布，其成本大约相当于现有商业上只能测量压力的工具的成本。该工具将是由Bertec开发的测力板，顶部涂有弹性表面应力敏感膜(S3F)，由ISSI开发。该设备将在克利夫兰诊所接受糖尿病患者和年龄匹配的对照组的测试，以更好地完善系统及其软件。它将能够测量地面反作用力以及当受试者走过板块时的连续压力和剪切分布。最终产品将引起生物机械师、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。但为了实现这一目标，必须实现以下具体目标：目标1，阶段I)将对压力和剪切敏感的弹性聚合物薄膜与6分量力板集成，以获得由于足底负载而产生地面反作用力加上聚合物薄膜中真实压力和剪切变形分布的原型仪器；目标2，阶段II)在目标1的原型产品上捕获精确的脚标位置，以便测量量可以准确地映射到脚上的物理位置；目标3，第二阶段)利用Innovative Science Solutions Inc.为表面应力敏感薄膜建立的有限元分析模型，以及来自力板的同步测量剪切力，将原型产品的剪切变形分布转换为剪应力分布。然后将此分析模块集成到Bertec的数字数据采集软件中，允许自动计算剪应力；AIM 4，第二阶段)将第一阶段和第二阶段的压力变形分布和足标位置数据合并到数据采集软件中。利用有限元分析模型和测力板同步测量的垂直力，校准压力变形模型，自动计算真实压力分布；以及目标5，二期)通过糖尿病患者和非糖尿病患者的临床试验，从功能和研究的角度评估原型系统的临床实用性，包括测量足底剪应力和压力分布的采集软件。