Investigating the Optimal Usage Time of Helmet in Babies With Deformational Plagiocephaly
试验速览
- 阶段
- 不适用
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- plagiocephaly severity scale
研究概览
简要总结
Investigating the optimal usage time of helmet therapy is the aim of the study. Participants will be babies with deformational plagiocephaly. Plagiocephalometric assesments will be utilize to follow improvement of head symmetry. Scales asking sensational integration and severity of plagiocephaly will also be used. Time of daily usage will be follow with daily asking the caregivers how long the baby wear the helmet in a day. Participants will follow for three months.
详细描述
Investigating the optimal usage time of helmet therapy is the aim of the study. Participants will be babies with deformational plagiocephaly. Plagiocephalometric assesments will be utilize to follow improvement of head symmetry. Scales asking sensational integration and severity of plagiocephaly will also be used. Time of daily usage will be follow with daily asking the caregivers how long the baby wear the helmet in a day. Participants will follow for three months. After the follow period completed, participants will be allocated two groups; avarage using 15-18 hours a day and avarage using 19-23 hours a day. Results will be compared for the two groups and correlation between the time of usage and cranial symmetry will be compare.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 7 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have deformational plagiocephaly consent from caregivers age between 1 day to 7 months
排除标准
- •have another systemic, neurologic or orthopedic problem
结局指标
主要结局
plagiocephaly severity scale
时间窗: Change from Baseline in head asymmetry at 6th weeks of treatment, at the end of the treatment/12th weeks
scale which has 5 subgroups as following frontal asymmetry, occipital flattening, head tilt, fascial asymmetry, ear asymmetry
次要结局
- Hemispheric asymmetry(Change from Baseline in head asymmetry at 6th weeks of treatment, at the end of the treatment/12th weeks)
研究者
hhotaman
PhD, Assoc Prof
Trakya University