Monitoring System for Cranial Orthoses

The University of Texas System (UT)

Status: Enrolling

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

Treatments: Device: Cranial Remolding Orthosis

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06425172

STU-2022-0556

Details and patient eligibility

About

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).

Full 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 60 minutes], (3) fitting of research helmet (if not done at Visit #2) and in-office testing [approximately 2 hours], (4)/(5)/(6) follow up visits for research helmet [approximately 30-60 minutes each], and (7) final follow up visit and in-office testing for the research helmet [approximately 2 hours].

During the 8-9 weeks of wearing the research helmet, the child is expected to wear the it 23 hours per day (after a break-in schedule), and caregivers will keep a log of helmet wear time and any side effects (such as skin irritations), if they occur. The child will be seen clinically every 2 weeks (or more often, if caregivers request additional checkups).

At the end of the trial, participants will return all research-related materials and the treating clinician will return the child to wearing the standard helmet.

Enrollment: 12 estimated patients

Sex: All

Ages: 3 to 18 months old

Volunteers: No Healthy Volunteers

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

Trial design

12 participants in 1 patient group

Infants with with deformational head shapes

Description:

Infants who have been referred for custom orthotic treatment for a deformational head shape such as deformational plagiocephaly or deformational brachycephaly.

Treatment:

Device: Cranial Remolding Orthosis