Actively Recruiting
Effectiveness of Repositioning, Physical Therapy, and Cranial Remolding in Infants With Cranial Deformation
Led by University of Texas Southwestern Medical Center ยท Updated on 2025-08-28
65
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Texas Southwestern Medical Center
Lead Sponsor
C
Children's Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate how well caregiver repositioning strategies and the use of a custom cranial remolding orthosis help correct deformational head shapes in infants. The study includes infants diagnosed with deformational cranial shapes, some of whom also have torticollis and will receive physical therapy. A group of healthy infants without head deformities will be observed to compare typical head growth with those undergoing treatment. Infants around 2 months old with deformational head shapes will start repositioning therapy at home, and physical therapy if they have torticollis. They will be checked monthly, and if the head shape remains unresolved by 4 to 6 months, parents can choose to begin treatment with a custom helmet worn most of the day. Treatment continues until the head shape is corrected or the infant reaches 12 months. Healthy infants will be evaluated but receive no treatment. Participants will attend follow-up visits at set ages to monitor head shape and treatment progress, including a final evaluation at 12 months. Researchers will measure the head shape at 12 months as the main outcome and assess overall changes and treatment compliance. The study tracks infant growth and response to treatments over time, ensuring careful monitoring of both treated and healthy infants.
CONDITIONS
Brief Title
Effectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy infants with normal physical development and no need for physical therapy intervention
You will not qualify if you...
- Infants with abnormal head shapes such as plagiocephaly or craniosynostosis
- Infants with growth abnormalities like genetic conditions
- Infants with developmental delays requiring physical or occupational therapy
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.
Duration - From 2 months of age until head shape resolution or 12 months of age
Participants with deformational head shape receive at-home repositioning therapy and physical therapy if torticollis is present, aimed at reshaping the infant's head.
Monthly visits for follow-up assessments
Duration - From approximately 4 months of age until head shape resolution or 12 months of age
Participants with residual cranial deformation after repositioning therapy may be treated with a custom cranial remolding orthosis worn 23 hours per day, with regular orthotist visits for adjustments and physical therapy if needed.
Visits every few weeks for orthosis adjustments
Duration - Up to 12 months of age
All infants, including healthy controls, are followed until 12 months of age for final evaluation of head shape.
1 final evaluation visit at 12 months of age
Trial Site Locations
Total: 1 location
1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
T
Tiffany Graham, MSPO
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here