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临床试验/NCT04141748
NCT04141748已完成不适用

Comparative Effectiveness of Socket Casting Methods: Improving Form and Fit

Northwestern University3 个研究点 分布在 2 个国家目标入组 80 人开始时间: 2020年9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
80
试验地点
3
主要终点
Socket Comfort Score

研究概览

简要总结

The overall objective is to compare hand casting to standing hydrostatic pressure casting using a water cylinder in persons with lower limb amputation. Our overall hypothesis is that standing hydrostatic pressure casting with a water cylinder will lead to more consistent and efficient residual limb shape capture and improved initial socket fit and comfort compared to hand casting.

详细描述

One of the most important components of restoring function in persons with lower limb amputation is the precise fitting of the prosthetic socket to the residual limb. However, this is challenging because the residual limb is dynamic in shape and volume. Additionally, prosthetic socket fabrication processes influence socket fit. These processes typically consist of residual limb shape capture, positive mold rectification, initial diagnostic socket fitting, and definitive prosthesis delivery. The most prevalent residual limb shape capture method involves a negative wrap cast in a non-weight bearing position and manual manipulation of the cast to conform to the residual limb shape. With this technique it is challenging to accurately capture the bony contours and distribute pressure evenly around the residual limb. To improve shape capture, techniques that rely less on manual manipulation by the prosthetist, such as standing hydrostatic pressure casting with a water cylinder have been developed. Given the use of physics to shape the residual limb, it has been proposed that pressure casting results in better fitting and more comfortable sockets, however this has not yet been demonstrated. The overall objective is to compare hand casting to standing hydrostatic pressure casting using a water cylinder in persons with lower limb amputation. Our overall hypothesis is that standing hydrostatic pressure casting with a water cylinder will lead to more consistent and efficient residual limb shape capture and improved initial socket fit and comfort compared to hand casting.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • •unilateral lower limb amputation (transtibial and transfemoral)
  • •current prosthesis users

排除标准

  • •poor residual limb sensation
  • •a superficial neuroma that is painful to pressure
  • •an open sore on the residual limb
  • •a residual limb circumference or body weight that exceeds the size or weight limits of the Symphonie Aqua SystemTM (i.e., >58cm and 170kg for persons with transtibial amputation and >78cm and 170kg for persons with transfemoral amputation
  • •persons who are unable to stand for the 4-6 minutes required for casting (e.g. persons with bilateral amputations).
  • •persons with new amputations (i.e., have been an amputee for less than 1 year)
  • •persons with transfemoral amputation who have a known silicone allergy or a femur length less than 5 inches

研究组 & 干预措施

Hand Casting

Active Comparator

hand cast will be taken using a circumferential plaster of Paris or fiber glass wrap of the residual limb with the subject in a seated position

干预措施: Hand Casting (Procedure)

standing hydrostatic pressure casting with a water cylinder

Active Comparator

hand cast will be taken using a circumferential plaster of Paris wrap of the residual limb with the subject in a seated position. The residual limb is then placed into the Symphonie Aqua System while in a weight bearing standing position.

干预措施: Symphonie Aqua SystemTM (Device)

结局指标

主要结局

Socket Comfort Score

时间窗: at study completion, 1 month

Score from 0-10, with 0 being the least comfortable socket and 10 being the most comfortable socket

次要结局

  • Procedure time(at every study visit, 1 month)
  • Cast/Socket volume(at every study visit, up to 1 month)
  • Socket Fit(at study completion, 1 month)
  • Socket preference(at study completion, 1 month)

研究者

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

Steven Gard

Associate Professor

Northwestern University

研究点 (3)

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