Brachycephaly, Plagiocephaly, Nonsynostotic
Conditions
Keywords
positional head deformity, helmet therapy, infants, thermoregulation, range of motion of the cervical spine
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.
Interventions
OTHERcranial 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.
Sponsors
Wroclaw University of Health and Sport Sciences
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
4 Months to 12 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed