Effect of Brim Height Using Vacuum Assisted Technology With Transfemoral Amputees
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
- 否
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
Eric Lamberg
Clinical Associate Professor
Stony Brook University
