Clinical Step Recorder

描述（由申请方提供）：糖尿病（DM）和周围神经病变（PN）患者下肢皮肤破裂和随后截肢的风险较高。压力的大小和重复性是皮肤破裂和神经性溃疡形成的重要指标。目前，还没有能够容易且不引人注目地测量压力的重复和在延长的时间段内的总承重时间的装置（例如，2周）。治疗这些神经性溃疡的最常见方法是使用全接触石膏（TCC）或踝足矫形器（AFO）减轻溃疡部位的重量。这项拨款提案的主要目的是开发一种不引人注目的，独立的，廉价的设备，可以装在鞋子，石膏或AFO中，它将记录和时间戳的步骤，平均压力和“高危”患者的负重时间。完成的临床步记录器（CSR）系统将在目前使用TCC的患者和穿着带矫正插入物的鞋的受试者中进行确认。CSR设备将有许多其他用途，包括肥胖患者或老年人的活动监测器，这可以帮助评估负重活动并鼓励定期体育活动

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