NCT07201324

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

Analysis of the Relationships Between Cranial Remolding Orthosis Therapy, Cervical Spine Motor Function, and Thermoregulatory Responses in Children With Cranial Deformity

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 270 (estimated)
• Sponsor: Wroclaw University of Health and Sport Sciences · Academic / Other
• Sex: All
• Age: 4 Months – 12 Months
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Plagiocephaly, Nonsynostotic
• Brachycephaly

Interventions

Type	Name	Description
OTHER	cranial helmet therapy - observational	This observational study involves children undergoing cranial helmet therapy. The intervention is not assigned by the investigator. Repeated measurements are performed within participants to evaluate therapy effects. Stage 1 assesses head shape changes to analyze therapy effectiveness. Stage 2 examines factors influencing effectiveness, considering age, deformity type, and sex. Stage 3 measures body surface temperature using thermal imaging before, during, and after helmet use, with participants analyzed in three age groups: 4-6, 7-9, and 10-12 months. Stage 4 evaluates cervical spine rotation before therapy and after completion, with participants analyzed in the same three age groups.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-12-01
• Completion: 2027-05-01
• First posted: 2025-10-01
• Last updated: 2025-10-01