Effectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation

The University of Texas System (UT)

Status: Enrolling

Conditions: Deformational Plagiocephaly; Congenital Muscular Torticollis; Brachycephaly; Deformational Posterior Plagiocephaly; Torticollis

Treatments: Device: Cranial Remolding Orthosis; Other: Repositioning Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05917678

STU 032017-036

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 estimated patients

Sex: All

Ages: 2 to 3 months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 3 patient groups

Repositioning Therapy

Other group

Description:

Infants will be treated with at-home repositioning strategies for their deformational head shape. Physical therapy will be provided, if indicated, for treatment of torticollis. This is a standard treatment.

Treatment:

Other: Repositioning Therapy

Repositioning Therapy + Cranial Remolding Orthoses

Other group

Description:

After attempting at 2-4 months of repositioning therapy, infants with residual cranial deformation may be treated with a custom made helmet (cranial remolding orthosis) which is adjusted every few weeks to direct skull growth. It is worn 23 hours per day. Physical therapy will be provided, if indicated, for treatment of torticollis. This is a standard treatment.

Treatment:

Other: Repositioning Therapy

Device: Cranial Remolding Orthosis

Control

No Intervention group

Description:

Healthy infants without deformational head shapes or need for physical therapy will be followed and measured. No intervention.