Plagiocephaly, NonsynostoticNCT07201324
Effects of Corrective Helmet Therapy on Cervical Motion and Thermoregulation in Children With Positional Deformities
An observational study of Plagiocephaly, Nonsynostotic and Brachycephaly, run by Wroclaw University of Health and Sport Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 12 months
- Conditions the study is for
- Plagiocephaly, Nonsynostotic, Brachycephaly
- What is being tested?
- cranial helmet therapy - observational
- How many people
- 270 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to May 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 months
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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).
Who cannot join
- craniosynostosis;
- hydrocephalus;
- non-adherence to 23-hour daily helmet use;
- metabolic disorders;
- torticollis.
About this study
Official title: Analysis of the Relationships Between Cranial Remolding Orthosis Therapy, Cervical Spine Motor Function, and Thermoregulatory Responses in Children With Cranial Deformity
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
- Being tested
- cranial helmet therapy - observational
- Keywords
- positional head deformity, helmet therapy, infants, thermoregulation, range of motion of the cervical spine
- Medical subject headings
- Plagiocephaly, Nonsynostotic, Craniosynostoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cranial helmet therapy - observationalOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: Before therapy during helmet adaptation and after completion of cranial helmet therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study startSep 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plagiocephaly, NonsynostoticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 270 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Wroclaw University of Health and Sport Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natalia Zielińska, Wroclaw University of Health and Sport Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201324
- Sponsor's protocol ID
- 26/2025
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Relationships Between Cranial Remolding Orthosis Therapy, Cervical Spine Motor Function, and Thermoregulatory Responses in Children With Cranial Deformity
- ClinicalTrials.gov ID
- NCT07201324
- Acronym / sponsor ID
- 26/2025
- Conditions
- Plagiocephaly, Nonsynostotic, Brachycephaly
- Keywords
- positional head deformity, helmet therapy, infants, thermoregulation, range of motion of the cervical spine
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Wroclaw University of Health and Sport SciencesUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 4 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- craniosynostosis;
- hydrocephalus;
- non-adherence to 23-hour daily helmet use;
- metabolic disorders;
- torticollis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cranial helmet therapy - observationalThis 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. | Other | – |
Primary outcome
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.
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.
3 secondary outcomes
Factors Determining Therapy Effectiveness
Time frame: Baseline (before therapy initiation) and after completion of cranial helmet therapy (average of 3-7 months after initiation)
Thermoregulatory Responses
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
Time frame: Before therapy during helmet adaptation and after completion of cranial helmet therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Plagiocephaly, Nonsynostotic and Brachycephaly, run by Wroclaw University of Health and Sport Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.