NCT01004926已完成1 期
Evaluation of the Efficiency of the Echelon Foot in Traumatic Trans Tibial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- While using the Echelon foot the amputees will present lower internal mechanical strain in the soft tissue of the stump while standing on a 10 degrees platform.
研究概览
简要总结
The aim of this work was to test the Echelon foot efficiency to offer enhanced safety, comfort and function over a wide range of walking surfaces, inclines and stairs, thereby improving the quality of life for amputees.
Ten individuals with a unilateral trans- tibial amputation will participate in two test sessions- one while using their own prosthetic foot, the other while using the Echelon foot.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Ten individuals with a unilateral trans tibial amputation due to trauma.
- •Walking at list one year from the end of their gait training. Mobility status is 3 or 4.
排除标准
- •Bilateral amputation.
- •Injury of the sound limb that compromises the gait of the amputee.
结局指标
主要结局
While using the Echelon foot the amputees will present lower internal mechanical strain in the soft tissue of the stump while standing on a 10 degrees platform.
时间窗: Beginning of the trial and one month after
次要结局
- Using the Echelon foot the Kinematic of level ground walking and climbing up and down stairs will be closer to normal curves.(At the beginning of the trial and one month later)
研究者
Dr. Itzhak Siev-Ner
Dr. Itzhak Siev-Ner
Sheba Medical Center
研究点 (1)
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