Monitoring System for Cranial Orthoses

A Monitoring System for Cranial Remolding Orthoses

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).

Study Overview

• Status: Completed
• Conditions: Plagiocephaly; Brachycephaly; Deformational Plagiocephaly; Deformational Posterior Plagiocephaly
• Intervention / Treatment: Device: Cranial Remolding Orthosis

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.

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Infants who are clinically indicated for cranial remolding orthoses.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Infants with with deformational head shapes; Infants who have been referred for custom orthotic treatment for a deformational head shape such as deformational plagiocephaly or deformational brachycephaly.	Device: Cranial Remolding Orthosis; A custom made FDA-approved cranial remolding orthosis will be retrofit with sensors used in the research.; Other Names: Custom Helmet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wear time monitoring and validation	The temperature readings from the custom temperature sensor within the research helmet will be compared to the collected temperature readings from the iButtons. Using established software compatible with the iButton, wear time will be calculated based on previously reported temperature thresholds which indicate the helmet is being worn. Using similar temperature thresholds, wear time data from the custom sensors will be compared to the wear time reported by the iButton software.	Data will be recorded for 8-9 weeks per subject, and analyzed throughout the study. Anticipated to be complete on all subjects within 1 year.
Fit monitoring	The investigators will examine pressure in the void space of the helmet throughout the 8-9 weeks of wear time. In theory, the pressure in this area should never increase as the cranium should not come in contact with this sensor no matter what position the infant is in (i.e. laying down, sitting, etc).	Data will be recorded for 8-9 weeks per subject, and analyzed throughout the study. Anticipated to be complete on all subjects within 1 year.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survey Participation	Parents will take a survey regarding their experience with the research helmet	Survey to be taken at completion of the study, anticipated to be complete on all subjects within 1 year.
Wear time comparison between objective and subjective reporting	The wear time based on iButton and custom temperature readings will be compared to the caregiver-reported wear time log and any differences in log times reviewed.	Data will be recorded for 8-9 weeks per subject, and analyzed throughout the study. Anticipated to be complete on all subjects within 1 year.

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: National Institute on Disability, Independent Living, and Rehabilitation Research
• Investigators: Principal Investigator: Tiffany Graham, MS, University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2024
• Primary Completion (Actual): March 12, 2026
• Study Completion (Actual): March 12, 2026

Study Registration Dates

• First Submitted: April 30, 2024
• First Submitted That Met QC Criteria: May 16, 2024
• First Posted (Actual): May 22, 2024

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Congenital Abnormalities; Bone Diseases, Developmental; Synostosis; Dysostoses; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Craniosynostoses; Plagiocephaly; Plagiocephaly, Nonsynostotic
• Other Study ID Numbers: STU-2022-0556

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will be protected and only shared within the research team and treating practitioners.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No