Actively Recruiting

Phase Not Applicable
Age: 2Months - 3Months
All Genders
Healthy Volunteers
NCT05917678

Effectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation

Led by University of Texas Southwestern Medical Center · Updated on 2025-08-28

65

Participants Needed

1

Research Sites

162 weeks

Total Duration

On this page

Sponsors

U

University of Texas Southwestern Medical Center

Lead Sponsor

C

Children's Health

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Effectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation

Who Can Participate

Age: 2Months - 3Months
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy infants with normal physical development and no need for physical therapy intervention
Not Eligible

You will not qualify if you...

  • Infants with abnormal head shapes such as plagiocephaly or craniosynostosis
  • Infants with growth abnormalities including genetic conditions
  • Infants with developmental delays significant enough to require physical or occupational therapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

Actively Recruiting

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Research Team

T

Tiffany Graham, MSPO

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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