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临床试验/NCT01309347
NCT01309347已完成不适用

Evaluation of the Development of an Advanced, Conformable Prosthetic Socket, Study I

Infoscitex Corporation1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2011年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
6
试验地点
1

研究概览

简要总结

The purpose of this study is obtain prosthetist's feedback on the novel conformable socket material developed by Infoscitex, and determine if it is a viable alternative to current prosthetic socket liners. During this task, the research team will travel to the prosthetists locations to have them evaluate the socket system by examining the material and providing their professional opinions and feedback with regard to comfort and fit for the amputee, its ease of use, and breathability.

详细描述

Modern prosthetics have improved significantly with regards to control and functionality, but the fit of the residual limb within a prosthetic socket is a primary concern for many amputees. A poor fit can lead to skin irritation, tissue breakdown, and pain. The volume of the residual limb of an amputee changes throughout the course of a day and throughout the year. Volume fluctuation within the socket can lead to issues for the amputee, including decreased comfort, increased shear forces, increased pressure on bony prominences, as well as a poor gait pattern. An uncomfortable or non-performing socket/residual limb interface decreases user compliance with the prosthetic and therefore decreases the activity level of amputees who want to remain active in their civilian and military lives.

The investigators are developing a multilayered socket that takes advantage of a novel braided material for strength and passive conformability with thin layers dedicated to wearer comfort. This new socket provides ultimate fit for improvement in the performance of the prosthesis. The socket adapts itself to the changing physical shape of the residual limb as the prosthesis is worn. The adaptation is a natural result of the material properties, so is done passively and in real time. The materials are lightweight, breathable, and ultrasound transparent, allowing the prosthetic to function in a variety of environments.

This study will be undertaken to have six prosthetists evaluate the material, where they will be asked to complete a questionnaire and give their opinions regarding the material. This will inform design changes for the material.

研究设计

研究类型
Observational
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •prosthetists who are active professionals and have clients (or have had clients in the past 6 months)

排除标准

  • •prosthetists who are not American Board for Certification of Orthotics and Prosthetics certified

研究者

申办方类型
Industry
责任方
Principal Investigator
主要研究者

Kristen Leroy

Group Leader, Biomedical Devices

Infoscitex Corporation

研究点 (1)

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