NCT02501408已完成4 期
Comparaison du Pied Bionique Proprio-Foot® Versus le Pied Habituel Chez Les amputés Tibiaux
University Hospital, Angers2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年3月9日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- oxygen consumption
研究概览
简要总结
Evaluate a new porosthetic device in lower limb amputees.
详细描述
Randomisation between usual and new prosthesis Cross over study of walking performance and VO2 on treadmill with the two devices after 1 month adaptation to each system.
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
- 否
入选标准
- •Tibial amputation
- •Ability top walk on treadmill
- •Stable prosthesis for at least 3 months
排除标准
- •Bilateral amputation
- •Absence of consent
研究组 & 干预措施
Propriofoot prosthesis
Experimental
New propriofoot prosthesis is worn instead of usual prosthesis foer 1 month
干预措施: propriofoot prosthesis (Device)
Control
No Intervention
Usual prosthesis is worn for 1 month
结局指标
主要结局
oxygen consumption
时间窗: 1 mois after adpatation of the selected device
Measurement on treadmill
次要结局
未报告次要终点
研究者
研究点 (2)
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