An observational study in Plagiocephaly, Nonsynostotic and Brachycephaly, sponsored by Wroclaw University of Health and Sport Sciences. Not yet recruiting. Open to participants aged 4 Months to 12 Months. Per ClinicalTrials.gov, last updated 2025-10-01.
Sponsored by Wroclaw University of Health and Sport Sciences · Observational
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.
51 studies on the registry are indexed under Craniosynostoses; 14 are open to participants now.
This study's planned enrollment of 270 is above the median of 43 across 26 observational studies indexed under Craniosynostoses.
Browse Craniosynostoses studies →Wroclaw University of Health and Sport Sciences is the lead sponsor of 46 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants are children from various cities in Poland, aged 4-12 months, diagnosed with severe or very severe positional head deformity and referred for cranial helmet therapy by a neurosurgeon. Both boys and girls are included. All referring physicians used the same standardized scale to determine the severity of the deformity, ensuring consistency across sites.
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Exclusion Criteria:
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.
Change in Cranial Index (CI)
Assessment of cranial proportion using the Cranial Index (CI) in children undergoing cranial helmet therapy. Each participant serves as their own control.
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)
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.
Time frame: Baseline (before therapy initiation) and after completion of cranial helmet therapy (average of 3-7 months after initiation).
Factors Determining Therapy Effectiveness
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.
Time frame: Baseline (before therapy initiation) and after completion of cranial helmet therapy (average of 3-7 months after initiation)
Thermoregulatory Responses
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.
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
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.
Time frame: Before therapy during helmet adaptation and after completion of cranial helmet therapy
No study locations are listed for this record.
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Wroclaw University of Health and Sport Sciences