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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age4-12
SponsorWroclaw University of Health and Sport Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

craniosynostosis;

hydrocephalus;

non-adherence to 23-hour daily helmet use;

metabolic disorders;

Trial 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.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • cranial helmet therapy - observational

    Other intervention

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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).
2

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).

Secondary outcomes

1

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)
2

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
3

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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