Monitoring System for Cranial Orthoses

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-18
SponsorUniversity of Texas Southwestern Medical Center

About this trial

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 criteria

Qualifiers

Infants who are clinically indicated for cranial remolding orthoses for treatment of a deformational head shape (i.e. plagiocephaly / brachycephaly)

Disqualifiers

non-English speaking caregivers

infants with craniosynostosis or those not indicated for cranial remolding

infants with developmental comorbidities which affect cranial growth

Trial design

Treatments tested in this trial

  • Cranial Remolding Orthosis

Treatment groups

12 Participants
are divided into 1 treatment group

Sponsors and collaborators

University of Texas Southwestern Medical Center

Lead sponsor

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator