JPRN-jRCTs032220285招募中2 期
Safety and efficacy of cranial remolding helmet with ventilation mechanism for treatment of deformational plagiocephaly: non-randomized non-blind prospective study
Hikosaka Makoto0 个研究点目标入组 5 人开始时间: 2022年8月22日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 < 6month old（—）
- 性别
- All
入选标准
- •1. Patients with deformational plagiocephaly
- •2. Patients who are younger than 6 months old at the start of helmet therapy
- •3. Patients with cranial asymmetry =>15
- •4. Patients who gained head and neck control
- •5. Patients whose guardians showed informed consent
排除标准
- •1. Patients with conditions which affect cranial shape (ie: hydrocephalus, craniosynostosis).
- •2. Patients with syndrome and other systemic comorbidity.
- •3. Patients with comorbidity of other organs (ie: metabolic disorders, heart defects).
- •4. Patients with disorders of head skin which makes helmet therapy difficult.
- •5. Patients who are expected to be lost to follow up during the study period.
- •6. Patients who are judged to be inappropriate by the investigator.
研究者
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