Effectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation

Torticollis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05917678
• Other study ID #: STU 032017-036
• Status: Recruiting
• Phase: N/A
• Start date: May 23, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: August 2023
• Source: University of Texas Southwestern Medical Center
• Contact: Tiffany Graham, MSPO
• Phone: 214-645-8250
• Email: Tiffany.Graham[@]utsouthwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months to 3 Months

Eligibility

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

Related Conditions & MeSH terms

• Brachycephaly
• Congenital Muscular Torticollis
• Craniosynostoses
• Deformational Plagiocephaly
• Plagiocephaly
• Plagiocephaly, Nonsynostotic
• Torticollis

Intervention

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.

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	Children's Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 months after enrollment (at 12 months of age)
Secondary	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.	Assessment to occur within 2 years of enrollment closure.
Secondary	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.	Assessment to occur within 2 years of enrollment closure.