RecruitingNCT06425172
Monitoring System for Cranial Orthoses
A Monitoring System for Cranial Remolding Orthoses
Sponsor
University of Texas Southwestern Medical Center
Enrollment
12 participants
Start Date
Aug 19, 2024
Study Type
OBSERVATIONAL
Conditions
Summary
This is a study which investigates the wear time and fit of a cranial remolding orthosis (a standard-of-care treatment where an infant wears a custom helmet to help reshape their head as they grow).
Eligibility
Min Age: 3 MonthsMax Age: 18 Months
Inclusion Criteria1
- Infants who are clinically indicated for cranial remolding orthoses for treatment of a deformational head shape (i.e. plagiocephaly / brachycephaly)
Exclusion Criteria3
- non-English speaking caregivers
- infants with craniosynostosis or those not indicated for cranial remolding
- infants with developmental comorbidities which affect cranial growth
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Interventions
DEVICECranial Remolding Orthosis
A custom made FDA-approved cranial remolding orthosis will be retrofit with sensors used in the research.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06425172