A Monitoring System for Cranial Remolding Orthoses
University of Texas Southwestern Medical Center
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).
Description
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). Although cranial remolding treatment has been used successfully for over 20 years, there is no clinical standard for objective monitoring of the fit and wear time. In total, participation will consist of 7 visits over 11 weeks: (1) measurements and clinical evaluation \[approximately 60 minutes\], (2) fitting of standard helmet and pre-fitting and/or fitting of the research helmet \[approximately…
Eligibility
- Age range
- 0–1 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Infants who are clinically indicated for cranial remolding orthoses for treatment of a deformational head shape (i.e. plagiocephaly / brachycephaly) Exclusion Criteria: * non-English speaking caregivers * infants with craniosynostosis or those not indicated for cranial remolding * infants with developmental comorbidities which affect cranial growth
Interventions
- DeviceCranial Remolding Orthosis
A custom made FDA-approved cranial remolding orthosis will be retrofit with sensors used in the research.
Location
- UT Southwestern Medical CenterDallas, Texas