Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-24 @ 1:37 PM
NCT ID:
NCT05848895
Eligibility Criteria:
Inclusions:
* Diagnosed with positional plagiocephaly
* Under 4-months of age (between birth - 4 months) at the time of enrollment
Exclusions:
* Preterm birth (\<37 weeks)
* Genetic syndromes
* Craniofacial defects/deformities (e.g. cleft lip/palate)
* Brachycephaly/scaphocephaly
* Hypotonia
* Hypertonia
* Craniosynostosis
* Head trauma or other neurological illnesses
* Lost to follow up
* Patient whose parents (or legal guardians) disagree to attend 8-treatments of OMT and 2 additional measurement sessions
* Prior helmet therapy, physical therapy, or OMT before the date of enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
4 Months
Study:
NCT05848895
Study Brief:
Protocol Section:
NCT05848895