Analysis of the Relationships Between Cranial Remolding Orthosis Therapy, Cervical Spine Motor Function, and Thermoregulatory Responses in Children With Cranial Deformity
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 270
- 主要终点
- Change in Cranial Index (CI)
研究概览
简要总结
The purpose of the study is to examine how cranial helmet therapy may affect neck movement and body temperature regulation in children with positional head deformity. The study will also look at factors that might influence how well the therapy works, such as the child's age, sex, and the type of head shape deformity.
During the study, children will undergo several assessments:
measurement of head shape using standard cranial indices, recording of body surface temperature with a thermal imaging camera, evaluation of neck mobility, focusing on rotation of the cervical spine.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 4 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •positional head deformity of severe or very severe degree;
- •age at therapy initiation: 4-12 months;
- •minimum therapy duration of 12 weeks (for Stage 1 and Stage 2).
排除标准
- •craniosynostosis;
- •hydrocephalus;
- •non-adherence to 23-hour daily helmet use;
- •metabolic disorders;
- •torticollis.
结局指标
主要结局
Change in Cranial Index (CI)
时间窗: Baseline (before therapy initiation) and after completion of cranial helmet therapy (average of 3-7 months after initiation).
Assessment of cranial proportion using the Cranial Index (CI) in children undergoing cranial helmet therapy. Each participant serves as their own control.
Change in Cranial Vault Asymmetry Index (CVAI)
时间窗: Baseline (before therapy initiation) and after completion of cranial helmet therapy (average of 3-7 months after initiation).
Assessment of head shape asymmetry using the Cranial Vault Asymmetry Index (CVAI) in children undergoing cranial helmet therapy. Each participant serves as their own control.
次要结局
- Factors Determining Therapy Effectiveness(Baseline (before therapy initiation) and after completion of cranial helmet therapy (average of 3-7 months after initiation))
- Thermoregulatory Responses(Before helmet application, after 30 minutes of helmet use, immediately after removal, 10 minutes and 15 minutes post-removal)
- Cervical Spine Rotation Range(Before therapy during helmet adaptation and after completion of cranial helmet therapy)
研究者
Natalia Zielińska
Master of Physiotherapy
Wroclaw University of Health and Sport Sciences