Hybrid Electrical-Mechanical Pump for Vacuum Suspension of Prosthetic Sockets
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Socket-reaction moments
研究概览
简要总结
Prostheses can be suspended from the amputated limb using a variety of techniques, such as straps and suction. Suspending the prosthesis by creating a vacuum between the prosthetic socket and limb using a pump has benefits over other techniques including improved limb health and mobility. A new pump design will be tested by prosthesis users in the laboratory to verify its functionality during walking.
详细描述
Human subject testing will involve a cross-sectional, repeated measures study consisting of a single 3 hour visit wherein participants will initially stand and then continuously walk at their self-selected speed for ten minutes on a level treadmill with the prototype under two randomly presented conditions of the mechanical system: 1) fully functional, and 2) locked to restrict axial displacement. After written informed consent is obtained, information on socket comfort and mobility capability will be collected. A load-cell will be installed proximal to the prototype and in-line with the prosthesis to measure instantaneous socket-reaction moments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to stand quietly and walk for 10 minutes continuously without an assistive device (e.g. cane or walker) and without undue fatigue or health risks
- •Pre-classified clinically to be at least a limited community ambulator of Medicare Functional Classification Level (K)2
- •Residual limb in good health
- •At least six months experience with a definitive prosthesis that utilizes vacuum assisted suspension
排除标准
- •Pathologies aside from amputation or taking medicine that would influence walking or balance
- •Poor prosthetic fit or poor residual limb sensation
研究组 & 干预措施
Locked
The prototype mechanical system is locked from compressing
干预措施: Pump prototype (Other)
Unlocked
The prototype mechanical system is free to compress normally
干预措施: Pump prototype (Other)
结局指标
主要结局
Socket-reaction moments
时间窗: Immediate
Maximum moment (torques) generated at the prosthetic socket end during walking
次要结局
- Perceived mobility capability(Immediate)
- Socket Comfort(Immediate)