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

NCT07201324 | Not Yet Recruiting

• 1 other identifier: 26/2025
• Study Type: observational
• Target: 270
• Locations: 0 countries
• Sites: N/A

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

Keywords

positional head deformity; helmet therapy; infants; thermoregulation; range of motion of the cervical spine

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline (before therapy initiation) and after completion of cranial helmet therapy (average of 3-7 months after initiation).

Secondary Outcomes (3)

• Factors Determining Therapy Effectiveness

  Baseline (before therapy initiation) and after completion of cranial helmet therapy (average of 3-7 months after initiation)

• Thermoregulatory Responses

  Before helmet application, after 30 minutes of helmet use, immediately after removal, 10 minutes and 15 minutes post-removal

• Cervical Spine Rotation Range

  Before therapy during helmet adaptation and after completion of cranial helmet therapy

Interventions

cranial helmet therapy - observational OTHER

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.

Eligibility Criteria

• Age: 4 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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).

You may not qualify if:

• craniosynostosis;
• hydrocephalus;
• non-adherence to 23-hour daily helmet use;
• metabolic disorders;
• torticollis.

Sponsors & Collaborators

• Wroclaw University of Health and Sport Sciences: lead

MeSH Terms

Conditions

Plagiocephaly, Nonsynostotic; Craniosynostoses

Condition Hierarchy (Ancestors)

Plagiocephaly; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Synostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master of Physiotherapy

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: October 1, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: October 1, 2025

Record last verified: 2025-09