Effects of Corrective Helmet Therapy on Cervical Motion and Thermoregulation in Children With Positional Deformities
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: cranial helmet therapy - observational.
- Who it may be relevant to
- Registry conditions: Plagiocephaly, Nonsynostotic, Brachycephaly. Basic parameters: 4 months — 12 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Analysis of the Relationships Between Cranial Remolding Orthosis Therapy, Cervical Spine Motor Function, and Thermoregulatory Responses in Children With Cranial Deformity
Overview
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.
Interventions
- 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 participant
Primary outcome measures
- Change in Cranial Index (CI) [Time frame: Baseline (before therapy initiation) and after completion of cranial helmet therapy (average of 3-7 months after initiation).]
- Change in Cranial Vault Asymmetry Index (CVAI) [Time frame: Baseline (before therapy initiation) and after completion of cranial helmet therapy (average of 3-7 months after initiation).]
Secondary outcome measures (3)
- Factors Determining Therapy Effectiveness [Time frame: Baseline (before therapy initiation) and after completion of cranial helmet therapy (average of 3-7 months after initiation)]
- Thermoregulatory Responses [Time frame: Before helmet application, after 30 minutes of helmet use, immediately after removal, 10 minutes and 15 minutes post-removal]
- Cervical Spine Rotation Range [Time frame: Before therapy during helmet adaptation and after completion of cranial helmet therapy]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07201324 · 26/2025