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

NCT ID: NCT07201324

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 270 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2027-05-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Months
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wroclaw University of Health and Sport Sciences

OTHER

Sponsor Role: lead

Responsible Party

Natalia Zielińska

Master of Physiotherapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

26/2025

Identifier Type: -

Identifier Source: org_study_id