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Search / Trial NCT05917678

Effectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation

Launched by UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER · Jun 14, 2023

Trial Information

Current as of July 06, 2025

Recruiting

Keywords

Plagiocephaly Brachycephaly Asymmetrical Brachycephaly Helmet Cranial Remolding Orthosis Repositioning Deformational Torticollis Normal

ClinConnect Summary

This clinical trial is studying how effective different treatments are for infants with certain head shape issues, like flat spots on the head or uneven skull shapes. The researchers want to see if simple repositioning techniques used by caregivers can help improve these head shapes, as well as how well a special helmet, called a cranial remolding orthosis, works for this purpose. Some infants who also have a condition called torticollis, which affects neck movement, will receive physical therapy while they participate in the study. The trial will also involve a group of healthy infants with normal head shapes to compare their growth with those receiving treatment.

To be eligible for the study, infants should be aged between 60 days and 91 days, and they should be healthy with normal physical development. Infants with abnormal head shapes or significant growth issues won't be included in the study. Participants can expect to be monitored as the researchers track changes in their head shapes over time, helping to improve understanding of these conditions and treatment options. This research is currently recruiting participants, so if you think your child might qualify, you could consider reaching out for more information.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria for Control Group:
  • Healthy infants with normal physical development and no need for physical therapy intervention
  • Exclusion Criteria for Control Group:
  • Infants with abnormal head shapes (plagiocephaly or craniosynostosis)
  • Infants with growth abnormalities (such as genetic conditions)
  • Infants with developmental delay significant to warrant physical therapy or occupational therapy

About University Of Texas Southwestern Medical Center

The University of Texas Southwestern Medical Center is a leading academic medical institution dedicated to advancing healthcare through innovative research, education, and clinical excellence. With a strong emphasis on translational medicine, the center conducts cutting-edge clinical trials aimed at developing novel therapies and improving patient outcomes across a wide range of diseases. Its multidisciplinary approach leverages a collaborative network of renowned faculty, state-of-the-art facilities, and a commitment to ethical research practices, positioning UT Southwestern at the forefront of medical discovery and patient care.

Locations

Dallas, Texas, United States

Patients applied

0 patients applied

Trial Officials

Tiffany Graham

Principal Investigator

University of Texas Southwestern Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported