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Effectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation

University of Texas Southwestern Medical Center · with Children's Health · NCT05917678

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 2 mo–4 mo · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
65
US sites recruiting
1
Study start
May 23, 2023
Record last updated
August 31, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

This study will examine how effective caregiver's repositioning strategies are in correcting an infant's deformational cranial shape, as well as the effectiveness of the use of a custom cranial remolding orthosis for treatment of deformational head shapes. Infants with torticollis will be concurrently enrolled in physical therapy treatment until the torticollis is resolved. A normal, unaffected population will be studied to compare typical growth to the growth of infants undergoing active treatment.

Being studied: Repositioning Therapy; Cranial Remolding Orthosis

Conditions: Deformational Plagiocephaly; Deformational Posterior Plagiocephaly; Brachycephaly; Torticollis; Congenital Muscular Torticollis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • University of Texas Southwestern Medical Center

    Dallas, TX 75390

    Site contact: Tiffany Graham, MSPO · 214-645-8250 · Tiffany.Graham@utsouthwestern.edu

Study contacts (from the official record)

  • Tiffany Graham, MSPO · 214-645-8250 · Tiffany.Graham@utsouthwestern.edu
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Effectiveness of Repositioning and Cranial Remolding in Infants… (NCT05917678) | Bored Studies