Biomechanical Superiority of Brimless Versus Ischial Ramus Containment (IRC) Sub Atmospheric Transfemoral Interfaces
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Balance and Stability
研究概览
简要总结
The investigators are comparing a new type of prosthetic socket for above knee amputees to the standard of care. The hypothesis is that the new type of socket will show equivalence to the standard of care using our designated outcome measures.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Unilateral transfemoral or knee-disarticulation amputee
- •18 to 85 years of age
- •K3 (variable cadence and community) ambulators;
- •Be able to independently provide informed consent
- •Be willing to comply with study procedures.
排除标准
- •History of chronic skin breakdown on the residual limb
- •Conditions that would prevent participation and pose increased risk (e.g. unstable cardiovascular conditions that preclude physical activity such as walking)
- •Use of any assistive devices/walking aids, beyond a prosthesis, to ambulate
- •Unwillingness/inability to follow instructions
研究组 & 干预措施
Active Comparator: Prosthetic socket standard of care
干预措施: Standard of care socket (Device)
Active Comparator: Prosthetic brimless socket
干预措施: Prosthetic brimless socket (Device)
结局指标
主要结局
Balance and Stability
时间窗: Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.
Balance and stability will be assessed for limits of stability and postural stability.
Quality of Life
时间窗: Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.
Validated surveys will be used to solicit participants' subjective experience and feedback.
Gait
时间窗: Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.
Gait will be assessed in terms of biomechanics and spatiotemporal parameters.
Socket Pressure
时间窗: 10 minutes after fitting with both sockets
Pressure sensors are placed on the skin and measured.
次要结局
未报告次要终点