NCT06762691尚未招募不适用
Cranial Remolding Orthosis Registry
Otto Bock HealthCare LP1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2025年4月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Asymmetry Index
研究概览
简要总结
A registry of infants fitted with a cranial remolding orthosis.
详细描述
The intention of the CRO registry is to gather real-world data of traditional and 3D-printed cranial remolding orthoses to compare outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has been evaluated and successfully scanned for a MyCRO Band or similar CRO
- •Patient's parent(s) or legal guardian(s) are able to communicate, provide feedback, understand and follow instructions during the course of the registry.
- •Parent(s) or legal guardian(s) are willing to provide informed consent.
排除标准
- •Patient is geographically inaccessible to comply and participate in the registry.
结局指标
主要结局
Asymmetry Index
时间窗: Baseline to final follow up visit (est. 6 months)
Correction in Cranial Vault Asymmetry Index (Plagiocephaly) or Cephalic Index (Brachycephaly)
次要结局
- Orthosis Utilization(Baseline to final follow up visit (est. 6 months))
- QUEST 2.0(Final follow up visit (est. 6 months))
研究者
研究点 (1)
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