No Power Bionic Lower Extremity Prosthesis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Peak Propulsive Ground Reaction Force on the Prosthetic Side During Walking
研究概览
简要总结
Typically people need separate prosthetic feet for running and walking. To bridge the gap, this study will test the Compliant Adaptive Energy Storage and Return (CAESAR) foot. This foot can change from a walk mode to a run mode with the push of a button. The investigators will test and improve this foot design mechanically, and then test this design on individuals with lower limb amputation in a lab setting. The goal of this project is to develop a passive prosthetic foot that can serve two purposes in someone's daily life: walking and running, to allow them to be more active.
详细描述
Typically people need separate prosthetic feet for running and walking. To bridge the gap, this study will test the Compliant Adaptive Energy Storage and Return (CAESAR) foot. This foot can change from a walk mode to a run mode with the push of a button. The investigators will test and improve this foot design mechanically, and then test this design on individuals with lower limb amputation in a lab setting. The goal of this project is to develop a passive prosthetic foot that can serve two purposes in someone's daily life: walking and running, to allow them to be more active. Here we will test this device to determine how it affects the user's mechanics during running and walking. Participants will come to a research laboratory for three test sessions where they will run and walk in their current foot, a commercial high-activity foot, and the prototype CAESAR foot.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years old
- •Transtibial amputation of one or both legs
- •Classified as K3 or K4 on the Medicare Functional Classification Level
- •Use of a well-fitting prosthetic socket and prosthetic foot for at least 6 months
- •Able to walk and run without assistance
排除标准
- •Significant injury to intact limb
- •History of balance impairments or neurologic disorders
- •Significant cardiovascular or respiratory disease
结局指标
主要结局
Peak Propulsive Ground Reaction Force on the Prosthetic Side During Walking
时间窗: All conditions were complete during 3 lab visits, approximately four hours long
Participants will walk over sensors that measure the force under their foot. Peak ground reaction force in the anterior direction is measured in Newtons and then divided by the individual's body weight (BW). The resultant force is measured in Body-weights.
Participants Perceived Comfort When Using Different Prosthetic Feet During Running
时间窗: All conditions were complete during 3 lab visits, approximately four hours long
Participants were asked their perceived comfort on a visual analog scale from 0 (most uncomfortable) to 100 (most comfortable)
Peak Propulsive Ground Reaction Force on the Prosthetic Side During Running
时间窗: All conditions were complete during 3 lab visits, approximately four hours long
Participants will run on a treadmill with force sensors below the treadmill belt. Data will be measured in Newtons and then normalized by dividing by body weight.
Participants Perceived Comfort When Using Different Prosthetic Feet During Walking
时间窗: All conditions were complete during 3 lab visits, approximately four hours long
Participants were asked their perceived comfort on a visual analog scale from 0 (most uncomfortable) to 100 (most comfortable)
次要结局
- Net V02 (Metabolic Cost) During Running(All conditions were complete during 3 lab visits, approximately four hours long)
研究者
Deanna H Gates
Associate Professor
University of Michigan