Actively Recruiting
A Monitoring System for Cranial Remolding Orthoses to Assess Wear Time and Fit in Infants with Deformational Head Shapes
Led by University of Texas Southwestern Medical Center · Updated on 2025-07-03
12
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Texas Southwestern Medical Center
Lead Sponsor
N
National Institute on Disability, Independent Living, and Rehabilitation Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the wear time and fit of a cranial remolding orthosis, which is a custom helmet used to help reshape an infant's head as they grow. This study addresses the need for an objective way to monitor how well and how long the helmet is worn, since no clinical standard currently exists despite over 20 years of use. Participants will attend seven visits over about 11 weeks, including evaluations, fitting of standard and research helmets, and follow-up visits. The infant will wear the research helmet for 8-9 weeks, aiming for about 23 hours a day after a break-in period, while caregivers keep a log of wear time and any side effects like skin irritation. The child will be seen clinically every two weeks or more often if needed. After the study, the research helmet and materials are returned, and standard helmet use resumes. During the study, researchers will monitor wear time and fit continuously over the 8-9 weeks, analyzing the data throughout the trial. Assessments include clinical evaluations, in-office testing, and caregiver surveys at study completion. Safety checks for side effects are done regularly, and the total participation time spans about 11 weeks with multiple clinic visits to support monitoring and care.
CONDITIONS
Brief Title
Monitoring System for Cranial Orthoses
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants clinically indicated for cranial remolding orthoses to treat deformational head shapes such as plagiocephaly or brachycephaly
You will not qualify if you...
- Caregivers who do not speak English
- Infants with craniosynostosis or not indicated for cranial remolding
- Infants with developmental comorbidities affecting cranial growth
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week
Participants are fitted with a standard cranial remolding orthosis and a research helmet fitted with sensors for monitoring wear time and fit.
2 to 3 visits (in-person)
Duration - 8 to 9 weeks
Participants wear the research helmet for 8 to 9 weeks with caregivers keeping logs of wear time and any side effects. Clinical checkups occur every 2 weeks or more frequently if requested.
Approximately 4 to 5 visits (in-person) every 2 weeks
Duration - 1 visit at the end of the monitoring period
Participants return research materials and transition back to the standard helmet. Final assessments and in-office testing are conducted.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
T
Tiffany Graham, MS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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