Effectiveness of Ottobock Helmet Therapy in Infants With Plagiocephaly, Brachycephaly or Combination of Both and Parents' Satisfaction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 452
- 试验地点
- 12
- 主要终点
- Cranial deformation index
研究概览
简要总结
The objective of the research is to measure the effectiveness of the Ottobock helmet, an innovative 3D-printed cranial orthosis used to correct infant cranial positional deformation: plagiocephaly, brachycephaly or combination of both.
This research is a retrospective multi-centric study composed of a collection of clinical data from orthotists database and a survey for patient's parents.
详细描述
The Ottobock helmet is a cranial orthosis used to correct infant cranial positional deformation: plagiocephaly, brachycephaly or combination of both. This medical device is a 3D-printed helmet, with an elastic closing system which allow the head growth, maintain a constant pressure in the helmet and ensure a good adjustment.
Even though there is an effectiveness observed, there are no existing clinical evidences on this type of helmet so far, and there is a need to conduct a research on a large number of patients to measure the effectiveness and describe the population treated. This study will give more information to health professionals (doctors, orthopedic technicians, etc.) and health authorities, about the benefits of the orthopedic treatment of the positional cranial deformations in infants.
The study is composed of an electronic case report form (eCRF) to be fulfilled by the orthotists and an electronic questionnaire (ePRO) to be fulfilled by the patient's parents. The electronic questionnaires, data treatment and analysis are handled by a Contract Research Organization (CRO).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 3 Months 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infant with positional cranial deformation
- •Infant treated with an Ottobock helmet between May 1st, 2020 and May 1st, 2021
排除标准
- •Patient whose parents (or legal guardians) disagree to participate in the study.
- •Patient whose parents (or legal guardians) are unable to understand or answer the questionnaire.
结局指标
主要结局
Cranial deformation index
时间窗: 6 weeks
The cranial deformation index is a ratio (%) of head diameters characterizing head deformation.
次要结局
- Satisfaction of parents regarding the device and the services provided by the orthotist(Through study completion, an average of 6 months)