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Abstract

Grant Number: 5R44HL083996-03
Project Title: Clinical Step Recorder
PI Information:NameEmailTitle
TARLER, MATTHEW D. mtarler@clevemed.com

Abstract: 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

Thesaurus Terms:
biomechanics, biomedical equipment development, gait, miniature biomedical equipment, monitoring device, portable biomedical equipment
computer data analysis, computer system design /evaluation, diabetic neuropathy, orthotics
clinical research, human subject

Institution: CLEVELAND MEDICAL DEVICES, INC.
CLEVELAND, OH 44103
Fiscal Year: 2006
Department:
Project Start: 01-OCT-2002
Project End: 30-JUN-2008
ICD: NATIONAL HEART, LUNG, AND BLOOD INSTITUTE
IRG: MRS


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