Effectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation

NCT05917678 | Recruiting FDA Device

• 1 other identifier: STU 032017-036
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

plagiocephaly; brachycephaly; asymmetrical brachycephaly; helmet; cranial remolding; orthosis; repositioning; deformational; torticollis; normal

Outcome Measures

Primary Outcomes (1)

• Final Head Shape

  Cranial measurements will be used to assess residual cranial deformation in affected infants. A group of unaffected, typically-developing infants will be used as normal growth examples. Measurements include 2-dimensional measurements (taken at the greater equator of the skull with cranial calipers or a measuring tape): Cranial circumference, medio-lateral dimension of the skull, anterior-posterior dimension of the skull, two opposing diagonal measurements taken 30 degrees from the mid-sagittal line. These will be used to calculate the asymmetry and proportion of the skull and track growth. Measurements include 3-dimensional measurements: 1) An FDA-approved non-invasive, eye-safe laser scanner called the STARscanner will be used to track measurements throughout treatment. For those who switch to Cranial Remolding Therapy, this scanner will be used for custom helmet fabrication. 2) The 3dMD system will use photographs to create a 3-dimensional rendering of your child's head.

  10 months after enrollment (at 12 months of age)

Secondary Outcomes (2)

• Overall Change in Head Shape

  Assessment to occur within 2 years of enrollment closure.

• Compliance with treatment

  Assessment to occur within 2 years of enrollment closure.

Study Arms (3)

Repositioning Therapy

OTHER

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.

Other: Repositioning Therapy

Repositioning Therapy + Cranial Remolding Orthoses

OTHER

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.

Other: Repositioning Therapy; Device: Cranial Remolding Orthosis

Control

NO INTERVENTION

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

Interventions

Repositioning Therapy 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; Repositioning Therapy + Cranial Remolding Orthoses

Cranial Remolding Orthosis 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.

Also known as: Helmet, Cranial Band, STARband

Repositioning Therapy + Cranial Remolding Orthoses

Eligibility Criteria

• Age: 2 Months - 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Children's Health: collaborator

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Plagiocephaly, Nonsynostotic; Craniosynostoses; Torticollis; Congenital torticollis; Plagiocephaly

Interventions

Head Protective Devices

Condition Hierarchy (Ancestors)

Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Synostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases; Dystonia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Personal Protective Equipment; Protective Devices; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Tiffany Graham

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiffany Graham, MSPO

CONTACT

214-645-8250; Tiffany.Graham@utsouthwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Infants with deformational head shapes start with repositioning strategies, then some will change to the orthotic intervention (custom remolding helmet). Healthy infants will only be followed, no intervention performed. All infants will be followed until 12 months of age.

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 26, 2023
• Study Start: May 23, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)