An interventional study of Repositioning Therapy and Cranial Remolding Orthosis in Deformational Plagiocephaly, Deformational Posterior Plagiocephaly and Brachycephaly, sponsored by University of Texas Southwestern Medical Center. Recruiting at 1 site in United States. Open to participants aged 2 Months to 3 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Treatment
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.
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.
51 studies on the registry are indexed under Craniosynostoses; 14 are open to participants now.
This study's planned enrollment of 65 is above the median of 27 across 22 interventional studies indexed under Craniosynostoses.
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Exclusion Criteria for Control Group:
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
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 · Device: Cranial Remolding Orthosis
Healthy infants without deformational head shapes or need for physical therapy will be followed and measured. No intervention.
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.
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.
Also known as: Helmet, Cranial Band, STARband
Final Head Shape
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.
Time frame: 10 months after enrollment (at 12 months of age)
Overall Change in Head Shape
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.
Time frame: Assessment to occur within 2 years of enrollment closure.
Compliance with treatment
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.
Time frame: Assessment to occur within 2 years of enrollment closure.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — No identifiable data will be shared outside of the study investigators.
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