Therapeutic Effects of Physical Function and Balance of Customized Insoles on Children With Developmental Delays
试验速览
- 阶段
- 不适用
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- change from baseline functional performance (scores) at 12 weeks
研究概览
简要总结
Using double blind, randomized controlled design to investigate the short-term therapeutic effects of function of customized insoles on children with developmental delays
详细描述
A total of 52 children with developmental delays will be enrolled. The participants will be randomized into two groups, including study group (with insoles) and control group (without insoles).
The participants in the study group will be evaluated at baseline, that is before the customized insoles are prescribed. All of evaluations, including physical function, balance, and quality of life will be re-evaluated up to 12 weeks after insoles wearing.
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
- 否
入选标准
- •developmental delays
排除标准
- •age less than 3 years old or older than 10 years old normal development
研究组 & 干预措施
study group: MEI BIN insoles
Participants in the study group will be prescribed with a pair of customized insoles (MEI BIN) to keep the subtalar joint in neutral position, for 12 weeks.
干预措施: MEI BIN insoles (Device)
control group: without MEI BIN insoles
Participants in this control group will not receive a pair of customized insoles (MEI BIN) to keep the subtalar joint in neutral position, for 12 weeks.
结局指标
主要结局
change from baseline functional performance (scores) at 12 weeks
时间窗: baseline and up to 12 weeks
Pediatric Outcome Data Collection Instrument
次要结局
- change from baseline balance (scores) at 12 weeks(baseline and up to 12 weeks)
- change from baseline physical function (time) at 12 weeks(baseline and up to 12 weeks)
- change from baseline quality of life at 12 weeks(baseline and up to 12 weeks)
研究者
Ru-Lan Hsieh
Professor
Taipei Medical University