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临床试验/NCT01559909
NCT01559909已完成1 期

Effect of Brim Height Using Vacuum Assisted Technology With Transfemoral Amputees

Stony Brook University4 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2012年6月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
10
试验地点
4
主要终点
Gait changes

研究概览

简要总结

Individuals with transfemoral (TF) amputation (above the knee amputation) may benefit from a socket that uses vacuum assisted suspension (VAS) to hold the socket onto the amputated limb. VAS may improve stability, weight bearing, comfort, proprioception, limb health, and function. To date, there is no evidence to support whether VAS alters balance, kinematics, and kinetics when walking for TF amputees as compared to conventional socket suspension technology. Further, there is question regarding what the optimal height of the socket should be to maintain stability and function. So long as stability is not sacrificed, it may be advantageous to lower the height of the socket to allow full hip motion and improve sitting comfort. The purpose of this investigation is to assess if the socket height alters the motion of the leg and changes the way one walks when using VAS compared to conventional socket suspension technology. In this study, TF amputees will be fitted with a VAS socket that will be attached to their current prosthesis using similar alignment. Individuals will be assessed while walking on a level floor and during stair negotiation while wearing the prosthesis with the VAS socket at various socket heights as well as their current socket. Additionally, balance and socket standing and sitting comfort will be investigated.

研究设计

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

入排标准

年龄范围
21 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female between the ages of 21 and 75 with a transfemoral amputation.
  • Limited household ambulators (K1) to those considered unlimited community ambulators (K4).
  • People who are comfortably fitted with a prosthesis for at least 6 months.

排除标准

  • People with severe cardiac or pulmonary disease that limits ability to walk.
  • People with too much discomfort and/or pain.
  • People with active wounds on their residual limb or other foot.

结局指标

主要结局

Gait changes

时间窗: 1 day

Step length, stride length, stance time, swing time, velocity

次要结局

  • Comfort(1 day)
  • Balance(1 day)

研究者

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

Eric Lamberg

Clinical Associate Professor

Stony Brook University

研究点 (4)

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