Status:
NOT_YET_RECRUITING
Effects of Corrective Helmet Therapy on Cervical Motion and Thermoregulation in Children With Positional Deformities
Lead Sponsor:
Wroclaw University of Health and Sport Sciences
Conditions:
Plagiocephaly, Nonsynostotic
Brachycephaly
Eligibility:
All Genders
4-12 years
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 facto...
Eligibility Criteria
Inclusion
- 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
- craniosynostosis;
- hydrocephalus;
- non-adherence to 23-hour daily helmet use;
- metabolic disorders;
- torticollis.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT07201324
Start Date
September 1 2025
End Date
May 1 2027
Last Update
October 1 2025
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