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临床试验/NCT00584103
NCT00584103已完成不适用

Evaluation of an Inexpensive Upper Extremity Prosthesis

University of Oklahoma1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2007年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1
试验地点
1
主要终点
correct application and maintenance of position of device

研究概览

简要总结

The purpose of this study is to evaluate a design of prosthesis that is inexpensive and able to fit a multitude of individuals. This may offer an off the shelf item for those that cannot afford a customized prosthesis, or wish to have an inexpensive spare.

详细描述

A prospective study will be done on an inexpensive below elbow upper extremity prosthesis. Prestige Healthcare Technologies Ltd. has developed a prosthesis that is easily and inexpensively fabricated. The prosthesis is similar to a fitting frame used by some prosthetists in trial fits to ensure proper length and angulation of the terminal device. The prosthesis consists of two pieces of aluminum bar stock running midline the length of the residual limb. One bar is located anteriorly, the other posteriorly. A terminal device will be placed in the receiver on the distal end of the prosthesis. An aluminum band will connect the anterior and posterior bar stock for structural stability. A finished figure of eight harness will be utilized for control and suspension of the prosthesis. The research performed will be noninvasive. The check out will be based on the New York University (NYU) trans-radial prosthesis checkout form. Prestige Healthcare Technologies has donated an adult size trans-radial prosthesis to be utilized for this study.

Each patient will serve as their own control group. The control group will be considered using the same guidelines for testing function of the patient's current prosthesis, which we will refer to as alpha P. The patient will then be fitted with the inexpensive model, which we will refer to as beta P. The results will be compared to the NYU standard as well as comparing between the results of alpha P and beta P. Beta P will be the same prosthesis personalized for subjects with the harness adjusted to properly fit each individual.

The benefit of this study may provide an inexpensive versatile alternative to the current below elbow prosthesis. This version may be utilized as a spare prosthesis while the patient is unable to use his primary prosthesis.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients with unilateral transradial amputation
  • Neurologically intact
  • At least 6 months post amputation surgery
  • Skin integrity intact without ulceration

排除标准

  • Bilateral upper extremity amputees
  • Patients that are insensate
  • Patients with poor skin integrity
  • Patients whose residual limb lengths preclude them from using the transradial prosthesis that is being evaluated

研究组 & 干预措施

Beta P Experimental

Experimental

Subjects will be fitted with the inexpensive prosthesis model from Prestige Healthcare Technologies. Then the terminal device will be fitted and evaluated using the NYU trans-radial prosthesis checkout form.

干预措施: Beta P Experimental (Device)

Alpha P Control

Other

Subjects will be fitted with a terminal device with their current prosthesis and evaluated using the NYU trans-radial prosthesis checkout form.

干预措施: Alpha P Control (Device)

结局指标

主要结局

correct application and maintenance of position of device

时间窗: 1 day -- time it takes to take measurements and make observations

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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