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Actively Recruiting

Phase Not Applicable
Age: 2Months - 3Months
All Genders
Healthy Volunteers
ID05917678

Effectiveness of Repositioning, Physical Therapy, and Cranial Remolding in Infants With Cranial Deformation

Led by University of Texas Southwestern Medical Center · 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

Age: 2Months - 3Months
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy infants with normal physical development and no need for physical therapy intervention
Not Eligible

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

Research Team

T

Tiffany Graham, MSPO

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