Effectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Repositioning Therapy, Cranial Remolding Orthosis.
- Who it may be relevant to
- Registry conditions: Deformational Plagiocephaly, Deformational Posterior Plagiocephaly, Brachycephaly, Torticollis. Basic parameters: 2 months — 3 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of Repositioning, Physical Therapy, and Cranial Remolding in Infants With Cranial Deformation
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.
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.
Interventions
- Other 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. - Device 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.
Primary outcome measures
- Final Head Shape [Time frame: 10 months after enrollment (at 12 months of age)]
Secondary outcome measures (2)
- Overall Change in Head Shape [Time frame: Assessment to occur within 2 years of enrollment closure.]
- Compliance with treatment [Time frame: Assessment to occur within 2 years of enrollment closure.]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Texas Southwestern Medical Center — Dallas
Identifiers
NCT: NCT05917678 · STU 032017-036