NCT Number: NCT05917678
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.
Interested in participating?
Request Info2 month–3 month
All sexes
Interventional
Not applicable
Dallas, Texas, 75390, United States
Location status: Recruiting
Alex Kane, MD
SUB_INVESTIGATOR
Caitlin Deville, DSc
SUB_INVESTIGATOR
Jijia Wang, PhD
SUB_INVESTIGATOR
Rami Hallac, PhD
SUB_INVESTIGATOR
Susan Simpkins, EdD
SUB_INVESTIGATOR
Tiffany Graham, MSPO
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for Control Group:
Exclusion criteria
for Control Group:
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.
Other names: Helmet, Cranial Band, STARband
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.
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.
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.
Contact information is provided by the study sponsor or research team.
University of Texas Southwestern Medical Center
Other
Effectiveness of Repositioning, Physical Therapy, and Cranial Remolding in Infants With Cranial Deformation
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06425172
Bone Diseases, Bone Diseases, Developmental
Dallas, Texas, United States
View Trial DetailsNCT07201324
Bone Diseases, Bone Diseases, Developmental
View Trial DetailsNCT06762691
Asymmetric Head, Bone Diseases
Madison Heights, Michigan, United States
View Trial DetailsNCT06186323
Congenital Muscular Torticollis, Congenital torticollis
Ankara, Turkey (Türkiye)
View Trial Details