Monitoring System for Cranial Orthoses

Recruiting

• Conditions: Plagiocephaly; Brachycephaly; Deformational Plagiocephaly; Deformational Posterior Plagiocephaly

• Registration Number: NCT06425172
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-4-30
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Inclusion Criteria:<br><br> - Infants who are clinically indicated for cranial remolding orthoses for treatment of<br> a deformational head shape (i.e. plagiocephaly / brachycephaly)<br><br>Exclusion Criteria:<br><br> - non-English speaking caregivers<br><br> - infants with craniosynostosis or those not indicated for cranial remolding<br><br> - infants with developmental comorbidities which affect cranial growth

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Wear time monitoring and validation;Fit monitoring

Secondary Outcome Measures

Name	Time	Method
Survey Participation;Wear time comparison between objective and subjective reporting