Recruiting

Cranial Orthosis

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT05917678

Conditions

Deformational Plagiocephaly

Deformational Posterior Plagiocephaly

Brachycephaly

Torticollis

Congenital Muscular Torticollis

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Interventions

Repositioning Therapy

Cranial Remolding Orthosis

Study Details

Brief summary:

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.

Conditions

Deformational Plagiocephaly

Deformational Posterior Plagiocephaly

Brachycephaly

Torticollis

Congenital Muscular Torticollis

Study ID

NCT05917678

Start date

May 23, 2023

Status verified date

Aug, 2026

Completion date

Aug 1, 2027

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

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

Study Design

Enrollment

65 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Repositioning Therapy

Infants will be treated with at-home repositioning strategies for their deformational head shape. Physical therapy will be provided, if indicated, for treatment of torticollis. This is a standard treatment.

other: Repositioning Therapy + Cranial Remolding Orthoses

After attempting at 2-4 months of repositioning therapy, infants with residual cranial deformation may be treated with a custom made helmet (cranial remolding orthosis) which is adjusted every few weeks to direct skull growth. It is worn 23 hours per day. Physical therapy will be provided, if indicated, for treatment of torticollis. This is a standard treatment.

no intervention: Control

Healthy infants without deformational head shapes or need for physical therapy will be followed and measured. No intervention.

Interventions

Repositioning Therapy

Caregivers will be instructed how to increase tummy time activities and reshape their infant's heads using at-home methods to direct their attention to the non-preferred side.

Cranial Remolding Orthosis

A custom cranial remolding orthosis (FDA Class II device) will be made to fit affected infants. this should be worn 23 hours per day and the Orthotist needs to be seen regularly for adjustments until the head shape is resolved.

Primary outcome measure

  • Final Head Shape [ Time Frame: 10 months after enrollment (at 12 months of age) ]

Central Contacts and Locations

Central contacts

Tiffany Graham, MSPO

214-645-8250Tiffany.Graham@utsouthwestern.edu

Locations

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Tiffany Graham, MSPO

214-645-8250Tiffany.Graham@utsouthwestern.edu

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Keywords

  • plagiocephaly
  • brachycephaly
  • asymmetrical brachycephaly
  • helmet
  • cranial remolding
  • orthosis
  • repositioning
  • deformational
  • torticollis
  • normal

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-08-31.