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

Not yet recruiting

• Conditions: Plagiocephaly, Nonsynostotic; Brachycephaly

• Registration Number: NCT07201324
• Lead Sponsor: Wroclaw University of Health and Sport Sciences

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted: 2025-09-16
• Study First Submitted QC: 2025-09-23
• Last Update Submitted: 2025-09-23
• Study First Posted: 2025-10-01
• Last Update Posted: 2025-10-01
• Primary Completion: 2026-12
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 270

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Cranial Index (CI)	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)	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.

Secondary Outcome Measures

Name	Time	Method
Factors Determining Therapy Effectiveness	Baseline (before therapy initiation) and after completion of cranial helmet therapy (average of 3-7 months after initiation)	Analysis of how age, sex, and type of deformity influence changes in head shape. Same children as in Primary Outcome are included, divided according to age, deformity type, and sex.
Thermoregulatory Responses	Before helmet application, after 30 minutes of helmet use, immediately after removal, 10 minutes and 15 minutes post-removal	Measurement of body surface temperature using thermal imaging to assess distribution and changes during and after cranial helmet therapy. Data will be analyzed in three age groups: 4-6, 7-9, and 10-12 months. Participants are different from those in the Primary Outcome.
Cervical Spine Rotation Range	Before therapy during helmet adaptation and after completion of cranial helmet therapy	Assessment of neck rotation range in children to evaluate changes in cervical spine mobility. Measurements will be analyzed in three age groups: 4-6, 7-9, and 10-12 months.