Effectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation

August 21, 2025 updated by: Tiffany Graham, University of Texas Southwestern Medical Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Infants 2 months of age who have been diagnosed with a deformational head shape will be begin repositioning therapy (and physical therapy if torticollis is present) and be followed at least monthly. At 4, 5, and 6 months of age, if the head shape has not resolved, they will be given the option to pursue treatment with a cranial remolding orthosis. All affected infants will undergo active treatment until the head shape is resolved or the infant is 12 months of age (whichever comes first).

Normal infants will be evaluated at 2, 6, and 12 months of age and will not be enrolled in any active treatment.

All infants will return at 12 months of age for a final evaluation.

Study Type

Interventional

Enrollment (Estimated)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas Southwestern Medical Center
        • Contact:
        • Sub-Investigator:
          • Rami Hallac, PhD
        • Sub-Investigator:
          • Jijia Wang, PhD
        • Sub-Investigator:
          • Alex Kane, MD
        • Sub-Investigator:
          • Caitlin Deville, DSc
        • Sub-Investigator:
          • Susan Simpkins, EdD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
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.
Other: 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.
Device: 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.
Other Names:
  • Helmet, Cranial Band, STARband
No Intervention: Control
Healthy infants without deformational head shapes or need for physical therapy will be followed and measured. No intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Final Head Shape
Time Frame: 10 months after enrollment (at 12 months of age)

Cranial measurements will be used to assess residual cranial deformation in affected infants. A group of unaffected, typically-developing infants will be used as normal growth examples.

Measurements include 2-dimensional measurements (taken at the greater equator of the skull with cranial calipers or a measuring tape): Cranial circumference, medio-lateral dimension of the skull, anterior-posterior dimension of the skull, two opposing diagonal measurements taken 30 degrees from the mid-sagittal line. These will be used to calculate the asymmetry and proportion of the skull and track growth.

Measurements include 3-dimensional measurements: 1) An FDA-approved non-invasive, eye-safe laser scanner called the STARscanner will be used to track measurements throughout treatment. For those who switch to Cranial Remolding Therapy, this scanner will be used for custom helmet fabrication. 2) The 3dMD system will use photographs to create a 3-dimensional rendering of your child's head.
10 months after enrollment (at 12 months of age)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Change in Head Shape
Time Frame: Assessment to occur within 2 years of enrollment closure.

The improvements seen in each of the 2 treatment arms will be compared to determine if one treatment has a greater impact than the other treatment.

Specifically, the difference between the baseline measurements (taken at 2 months of age) and the updated measurements (taken at each study measurement timepoint) will be compared in 2-dimensions and 3-dimensions. The group with greater correction to the cranial deformity would be considered the more impactful treatment method.
Assessment to occur within 2 years of enrollment closure.
Compliance with treatment
Time Frame: Assessment to occur within 2 years of enrollment closure.

Overall compliance with each treatment method will be assessed.

Caregivers of affected infants will be given surveys at each follow up appointment to assess adherence to the treatment arm's protocol. Surveys will include questions specific to the infant's treatment arm, which may include questions such as how long the child remains in a repositioned position before moving themselves, how many hours per day the infant is wearing their custom helmet, and how often caregivers are performing the recommended neck stretches.

No surveys will be given to the typically-developing control group as there is no active treatment for this group.
Assessment to occur within 2 years of enrollment closure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Collaborators

Children's Health

Investigators

  • Principal Investigator: Tiffany Graham, University of Texas Southwestern Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

June 5, 2023

First Submitted That Met QC Criteria

June 14, 2023

First Posted (Actual)

June 26, 2023

Study Record Updates

Last Update Posted (Estimated)

August 28, 2025

Last Update Submitted That Met QC Criteria

August 21, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU 032017-036

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No identifiable data will be shared outside of the study investigators.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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