NCT05917678

Effectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 2 Months – 3 Months
• Healthy volunteers: Accepted

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.

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.

Conditions

• Deformational Plagiocephaly
• Deformational Posterior Plagiocephaly
• Brachycephaly
• Torticollis
• Congenital Muscular Torticollis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-05-23
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2023-06-26
• Last updated: 2025-08-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study