Effectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation

NCT ID: NCT05917678

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-23
• Study Completion Date: 2026-07-01

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Repositioning Therapy

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.

Group Type: OTHER

Repositioning Therapy

Intervention Type: OTHER

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.

Repositioning Therapy + Cranial Remolding Orthoses

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.

Group Type: OTHER

Repositioning Therapy

Intervention Type: OTHER

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.

Cranial Remolding Orthosis

Intervention Type: DEVICE

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.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: DEVICE

Other Intervention Names

Helmet, Cranial Band, STARband

Eligibility Criteria

Inclusion Criteria

• Healthy infants with normal physical development and no need for physical therapy intervention

Exclusion Criteria

• 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

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Children's Health

OTHER

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Tiffany Graham

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tiffany Graham

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Tiffany Graham, MSPO

Role: CONTACT

Tiffany.Graham@utsouthwestern.edu

214-645-8250

Facility Contacts

Tiffany Graham, MSPO

Role: primary

Tiffany.Graham@utsouthwestern.edu

214-645-8250

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

STU 032017-036

Identifier Type: -

Identifier Source: org_study_id