About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
craniosynostosis;
hydrocephalus;
non-adherence to 23-hour daily helmet use;
metabolic disorders;
Trial design
Treatments tested in this trial
- cranial helmet therapy - observational