Therapeutic Effects of Customized Insoles on Children With Flat Foot
试验速览
- 阶段
- 4 期
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- health related quality of life (Pediatric Quality of Life Inventory (PedQoL)
研究概览
简要总结
Using double blind, randomized controlled design to study the short-term therapeutic effects of customized arch-support shoe insoles to children with flat foot.
详细描述
A total of 52 children with flat foot will be collected. The participants will be randomized into two groups, including study group (insoles group) and control group (without insole group).
All participants in the insoles group will be evaluated at baseline, that is before the customized full-length shoe insoles are prescribed. All the evaluations, including physical functional ability, balance, physical activity, functional performance, and quality of life will be re-evaluated up to 12 weeks after shoe insoles wearing in the insoles group.
The control group will be evaluated at the baseline and up to 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •flat foot
排除标准
- •age less than 3 years old or older than 10 years old
- •pathological flat foot
结局指标
主要结局
health related quality of life (Pediatric Quality of Life Inventory (PedQoL)
时间窗: baseline and up to 12 weeks
Pediatric Quality of Life Inventory (PedQoL)
次要结局
- functional performance (Pediatric Outcome Data Collection Instrument)(baseline and up to 12 weeks)
研究者
Ru-Lan Hsieh
Shin Kong Wu Ho-Su Memorial Hospital
Taipei Medical University