Monitoring System for Cranial Orthoses

Plagiocephaly Clinical Trial

Official title:

A Monitoring System for Cranial Remolding Orthoses

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06425172
• Other study ID #: STU-2022-0556
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: May 2024
• Source: University of Texas Southwestern Medical Center
• Contact: Tiffany Graham, MS
• Phone: 2146458250
• Email: Tiffany.Graham[@]utsouthwestern.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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 weeks of wearing the research helmet, the child is expected to wear the it 23 hours per day, 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 18 Months

Eligibility

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

Related Conditions & MeSH terms

• Brachycephaly
• Craniosynostoses
• Deformational Plagiocephaly
• Plagiocephaly
• Plagiocephaly, Nonsynostotic

Intervention

Device:
• Cranial Remolding Orthosis
A custom made FDA-approved cranial remolding orthosis will be retrofit with sensors used in the research.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	National Institute on Disability, Independent Living, and Rehabilitation Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 weeks per subject, and analyzed throughout the study. Anticipated to be complete on all subjects within 1 year.
Primary	Fit monitoring	We will examine pressure in the void space of the helmet throughout the 8 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 weeks per subject, and analyzed throughout the study. Anticipated to be complete on all subjects within 1 year.
Secondary	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.
Secondary	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 weeks per subject, and analyzed throughout the study. Anticipated to be complete on all subjects within 1 year.