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NCT Number: NCT07201324

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

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.

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Key information

Conditions

Plagiocephaly, Nonsynostotic Bone Diseases Bone Diseases, Developmental Brachycephaly Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Craniosynostoses Dysostoses Musculoskeletal Abnormalities Musculoskeletal Diseases Plagiocephaly Synostosis

Age range

4 month–12 month

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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).

    Assessment of cranial proportion using the Cranial Index (CI) in children undergoing cranial helmet therapy. Each participant serves as their own control.

  2. 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).

    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 outcomes

  1. Factors Determining Therapy Effectiveness

    Time frame: 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.

  2. Thermoregulatory Responses

    Time frame: 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.

  3. Cervical Spine Rotation Range

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Wroclaw University of Health and Sport Sciences

Other

Registry information

Official study title

Analysis of the Relationships Between Cranial Remolding Orthosis Therapy, Cervical Spine Motor Function, and Thermoregulatory Responses in Children With Cranial Deformity

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Oct 1, 2025
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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