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

Status Recruiting

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT05917678
• Study type: Interventional
• Source: University of Texas Southwestern Medical Center
• Contact: Tiffany Graham, MSPO
• Phone: 214-645-8250
• Email: Tiffany.Graham@utsouthwestern.edu
• Status: Recruiting
• Phase: N/A
• Start date: May 23, 2023
• Completion date: July 1, 2024