Validation of an Ankle Foot Orthosis With Anterior Support for Foot Drop
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Easy to put on orthosis
研究概览
简要总结
The objective of this research is to compare the new ankle foot orthosis (AFO) with prior support developed by Turbomed, with the AFO with posterior support from Turbomed as well as two competing AFOs currently on the market.
With this research, we seek to answer the following questions:
- Is the new AFO as biomechanically efficient as the AFOs currently on the market?
- Is the new AFO more comfortable than the AFO currently on the market?
- Is the new AFO easier to put on and attach than the AFOs currently on the market?
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Foot drop following surgery or an accident (functional calf, without contracture and not spastic)
- •Foot drop following a Cerebral Vascular Accident (with or without spasticity, mild to moderate)
- •Ability to stand and walk alone without technical assistance
- •Ability to communicate comfort/discomfort
排除标准
- •Sore to one of the feet
结局指标
主要结局
Easy to put on orthosis
时间窗: At delivery
Easy to put on is measured with a Likert scale from 1 (very difficult) to 5 (very easy).
Knee flexion angle during gait
时间窗: At delivery
Maximum, minimum and range of motion of the knee flexion angle during gait.
Minimum foot clearance
时间窗: At delivery
Minimum foot clearance is defined as the minimum distance between the foot and the ground during swing.
Hip flexion angle during gait
时间窗: At delivery
Maximum, minimum and range of motion of the hip flexion angle during gait.
Comfort of participants with orthosis
时间窗: At delivery
Comfort is measured with a Likert scale from 1 (not comfortable) to 5 (very comfortable).
次要结局
未报告次要终点