CompletedNot Applicable

Observe the Effects of the Serkel Cranial Remolding Orthosis on Infants With Deformational Plagiocephaly

United States18 participantsStarted 2022-05-24

Plain-language summary

The purpose of this study is to determine the safety and effectiveness of a specific brand of cranial remolding orthosis (a custom made helmet), which is new to the United States market

Who can participate

Age range4 Months – 18 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participants between the ages of 4-18 months at evaluation * Participants with physician prescription of CRO treatment * Participants with physician diagnosis of deformational plagiocephaly * Participants who skulls measurements qualify them for standard CRO treatment (CVA measurement is greater than 6mm and Cephalic Index is greater than 92%) Exclusion Criteria: * Participants younger than 4 months at evaluation * Participants older than 18 months at evaluation * Participants without physician prescription for CRO treatment * Participants without physician diagnosis of deformational plagiocephaly * Participants whos skull measurements or asymmetries do not qualify them for standard CRO treatment

What they're measuring

Change in Cranial Measurements as Measured by CVA

Timeframe: Baseline, approximately 4-6 months

Change in Cranial Measurements as Measured by Cephalic Index

Timeframe: Baseline, approximately 4-6 months

Trial details

NCT IDNCT06831513

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-05

Results submitted2025-04-08

View on ClinicalTrials.gov More Plagiocephaly, Nonsynostotic trials