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Effectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation

Recruiting
2 - 3 years of age
Both
Phase N/A

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Overview

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.

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

Study details

Deformational Plagiocephaly, Deformational Posterior Plagiocephaly, Brachycephaly, Torticollis, Congenital Muscular Torticollis

NCT05917678

University of Texas Southwestern Medical Center

25 January 2024

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