Effects of Corrective Helmet Therapy on Cervical Motion and Thermoregulation in Children With Pos… (NCT07201324) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effects of Corrective Helmet Therapy on Cervical Motion and Thermoregulation in Children With Positional Deformities
270 participantsStarted 2025-09
Plain-language 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.
Who can participate
Age range
4 Months – 12 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Cranial Index (CI)
Timeframe: 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)
Timeframe: Baseline (before therapy initiation) and after completion of cranial helmet therapy (average of 3-7 months after initiation).
Trial details
NCT IDNCT07201324
SponsorWroclaw University of Health and Sport Sciences