Therapeutic Effects of Physical Function and Balance of Arch Support Insoles on Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- change of baseline of level walking time to 12 weeks
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 insoles on children
详细描述
A total of 45 children were enrolled. The children were randomized into two groups, including the study group (insoles group) and the control group (without insoles group).
All participants in the insoles group were evaluated at baseline, that was before the customized arch-support insoles were prescribed. All the evaluations, including functional performance, physical function, and quality of life, were re-evaluated up to 12 weeks after the insoles wearing in the study group (insoles group).
The control group were evaluated at 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
- •children with age 3 to 10 can walk independently for 15 meters can follow up for 12 weeks
排除标准
- •age less than 3 years or older than 10 years children with developmental delays children with pathological flat feet
结局指标
主要结局
change of baseline of level walking time to 12 weeks
时间窗: baseline and up to 12 weeks
time of level walking
change of baseline of stairs climbing time to 12 weeks
时间窗: baseline and up to 12 weeks
time of stairs climbing
change of baseline of chair raising time to 12 weeks
时间窗: baseline and up to 12 week
time of chair raising
change of baseline of up and go time to 12 weeks
时间窗: baseline and up to 12 weeks
time of up and go
次要结局
- change of baseline functional performance(scores) to 12 weeks(baseline and up to 12 weeks)
- change of baseline balance (scores) to 12 weeks(baseline and up to 12 weeks)
- change of baseline quality of life (scores) to 12 weeks(baseline and up to 12 weeks)
研究者
Ru-Lan Hsieh
primary investigator
Taipei Medical University