Clinical Step Recorder

临床步骤记录仪

• 批准号: 6999257
• 负责人: MATTHEW D. TARLER
• 金额: $ 58.18万
• 依托单位: CLEVELAND MEDICAL DEVICES, INC.
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-10-01 至 2007-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6999257
• 关键词: biomechanics; biomedical equipment development; clinical research; computer data analysis; computer system design /evaluation; diabetic neuropathy; gait; human subject; miniature biomedical equipment; monitoring device; orthotics; portable biomedical equipment

DESCRIPTION (provided by applicant): Patients with diabetes mellitus (DM) and peripheral neuropathy (PN) are at high risk for lower extremity skin breakdown and subsequent amputation. Magnitude and repetition of pressures are important indicators of skin breakdown and formation of neuropathic ulcers. Currently, there are no devices that can easily and unobtrusively measure the repetition of pressures and total weight-bearing time over a prolonged period of time (e.g., 2 weeks). The most common method of treatment of these neuropathic ulcers is off loading weight over the ulcer site using a total contact cast (TCC) or an ankle foot orthosis (AFO). The primary purpose of this grant proposal is to develop an unobtrusive, self-contained, inexpensive device that can fit inside a shoe, cast, or AFO, that will record and time stamp steps, average pressures, and weight-bearing time for "at-risk" patients for extended periods of time. The completed Clinical Step Recorder (CSR) system will be validated with patients currently using a TCC, and subjects wearing shoes with orthotic inserts. The CSR device will have many other uses, including that of an activity monitor for patients with obesity, or the elderly, which could help assess weight-bearing activities and encourage regular physical activities

描述（由申请人提供）：糖尿病（DM）和周围神经病变（PN）患者下肢皮肤破裂并随后截肢的风险很高。压力的大小和重复是皮肤破裂和神经性溃疡形成的重要指标。目前，还没有一种设备可以轻松且不显眼地测量长时间（例如，2周）内的重复压力和总负重时间。治疗这些神经性溃疡最常见的方法是使用全接触石膏（TCC）或踝足矫形器（AFO）减轻溃疡部位的负荷。这项拨款提案的主要目的是开发一种不显眼的、独立的、廉价的设备，可以装在鞋子、石膏或AFO中，为“有风险”的患者长时间记录步数、平均压力和负重时间。完成的临床步数记录仪（CSR）系统将在目前使用TCC的患者和穿着带矫形垫的鞋子的受试者中进行验证。CSR设备还有许多其他用途，包括肥胖患者或老年人的活动监测器，它可以帮助评估负重活动并鼓励定期体育锻炼