Biomechanical Evaluation of a Novel, Compliant Low Profile Prosthetic Foot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Total Energy Stored (TES)
研究概览
简要总结
The investigators have developed a novel layered low-profile prosthetic foot that is able to provide enhanced compliance without sacrificing strength for individuals with transtibial amputation who have long residual limbs. It is hypothesized that the proposed prosthesis will offer similar benefits to these individuals as comparable higher profile prostheses offer users with shorter residual limbs. The primary goal of this Phase I proposal is to assess the degree to which the proposed prosthesis can provide benefits to prosthesis users in this population, along with characterizing the degree to which the novel prosthesis emulates its taller counterparts.
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
- Single (Participant)
盲法说明
The control prosthesis and the experimental prosthesis are covered by a sock to prevent the participant from knowing which has been fit.
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-89 years old
- •unilateral transtibial amputation
- •daily use of a low profile foot
- •cognitive ability to understand and willingness to provide informed consent and follow the study protocol
排除标准
- •unable to perform walking for 2 minutes without an assistive device
- •other health conditions which may prevent them from participating in the study
结局指标
主要结局
Total Energy Stored (TES)
时间窗: through study completion, an average of 1 day
TES is the amount of energy absorbed by the ankle joint during early and middle stance. It is the integral of the product of joint torque and angular velocity, as determined through inverse dynamics.
Total Energy Stored (TES)
时间窗: through study completion, an average of 1 day
TES is the amount of energy absorbed by the ankle joint during early and middle stance. It is the integral of the product of joint torque and angular velocity, as determined through inverse dynamics.
次要结局
- Ankle Quasi-Stiffness (AQS)(through study completion, an average of 1 day)
- Walking Speed(through study completion, an average of 1 day)
- Ankle Quasi-Stiffness (AQS)(through study completion, an average of 1 day)
- Walking Speed(through study completion, an average of 1 day)
- Likert Scale Rating of Device Satisfaction(through study completion, an average of 1 day)