Effectiveness of Parent's Manipulation in Newborn With Metatarsus Adducts.a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- evidence of no foot deformity of newborn
研究概览
简要总结
The purpose of this study is to determine whether the result of parent's feet manipulation compared with nonmanipulated group within first 6 months of life and observe spectrum of the disease within this period.
详细描述
The newborn with metatarsus adducts are included in the study and divide in 2 groups by random.Group A with parents'manipulation of the foot and group B without manipulation of the foot.The parents'foot manipulation is trained by pediatric orthopedic surgeons to correct the deformity.The effectiveness of the manipulation is measured by percentage of no deformity of the foot in newborn after 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •newborn with Metatarsus adducts.
排除标准
- •criteria were included newborns with associated life threatening conditions.
- •congenital or musculoskeletal problems.(ie;arthrogryposis multiplex congenita,skeletal dysplasia)
- •mental retardation.
- •cognitive impairment.
- •parents incooperative.
- •difficult to follow up patients.
结局指标
主要结局
evidence of no foot deformity of newborn
时间窗: 6 month
in the group of parents manipulation or in the group without parents manipulation ,for the period of 6 months the outcomes measurement will be done to assess the evidence of foot deformity remaining by pediatric orthopedic surgeons, the outcomes will be the percentage of success or success rate
次要结局
- the statistical significant difference between sex and duration from disease to cure(6 month)