Effects of Corrective Helmet Therapy on Cervical Motion and Thermoregulation in Children With Positional Deformities

Wroclaw University of Health and Sport Sciences

Status: Not yet enrolling

Conditions: Brachycephaly; Plagiocephaly, Nonsynostotic

Treatments: Other: cranial helmet therapy - observational

Study type: Observational

Funder types: Other

Identifiers

NCT07201324

26/2025

Details and patient eligibility

About

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.

Enrollment: 270 estimated patients

Sex: All

Ages: 4 to 12 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

• craniosynostosis;
• hydrocephalus;
• non-adherence to 23-hour daily helmet use;
• metabolic disorders;
• torticollis.