Dimensional Validation of the Hallux Valgus Orthosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Change in pain at 1 month
研究概览
简要总结
The goal of this project is to optimize the design of the orthosis by establishing the key volumetric characteristics of the custom iterations in order to subsequently transpose them to a standard model and establish the increment proportions of the different sizes. The final product should reduce the pain by repositioning the phalanges of the first toe with the first metatarsal in its axis.
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
- •Painful hallux valgus
- •three people maximum per shoe size
排除标准
- •People with diabetes ;
- •People with severe obesity ;
- •People with hallux rigidus;
- •People wearing full-time foot orthosis;
- •People wearing high heel shoes regularly ;
- •People with degenerative disease ;
- •People with neuromuscular pathology ;
- •People with a circulatory disorder ;
- •People who have had major lower body surgery;
- •People with epilepsy or with a history of epilepsy.
研究组 & 干预措施
Painful Hallux Valgus
干预措施: Hallux Valgus orthosis (Device)
结局指标
主要结局
Change in pain at 1 month
时间窗: At baseline and 1 month
Pain is measured with a Likert scale from 1 (decrease of pain) to 5 (increase of pain).
Change in comfort at 1 month
时间窗: At baseline and 1 month
Comfort is measured with a Likert scale from 1 (not comfortable) to 5 (very comfortable).
Change in big toe deviation angle during gait at 1 month
时间窗: At baseline and 1 month
The big toe deviation angle is the angle between the big toe and the gait axis and measured with a motion capture system.
次要结局
未报告次要终点