NCT06425172

Monitoring System for Cranial Orthoses

A Monitoring System for Cranial Remolding Orthoses

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 12 (estimated)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 3 Months – 18 Months
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Plagiocephaly
• Brachycephaly
• Deformational Plagiocephaly
• Deformational Posterior Plagiocephaly

Interventions

Type	Name	Description
DEVICE	Cranial Remolding Orthosis	A custom made FDA-approved cranial remolding orthosis will be retrofit with sensors used in the research.

Timeline

• Start date: 2024-08-19
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2024-05-22
• Last updated: 2025-07-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study