Back to resultsEffectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation
Primary Purpose
Deformational Plagiocephaly, Deformational Posterior Plagiocephaly, Brachycephaly
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Repositioning Therapy
Cranial Remolding Orthosis
Sponsored by
About this trial
This is an interventional treatment trial for Deformational Plagiocephaly focused on measuring plagiocephaly, brachycephaly, asymmetrical brachycephaly, helmet, cranial remolding, orthosis, repositioning, deformational, torticollis, normal
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
Sites / Locations
- University of Texas Southwestern Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
No Intervention
Arm Label
Repositioning Therapy
Repositioning Therapy + Cranial Remolding Orthoses
Control
Arm 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.
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.
Healthy infants without deformational head shapes or need for physical therapy will be followed and measured. No intervention.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Overall Change in Head Shape
The improvements seen in each of the 2 treatment arms will be compared to determine if one treatment has a greater impact than the other treatment.
Specifically, the difference between the baseline measurements (taken at 2 months of age) and the updated measurements (taken at each study measurement timepoint) will be compared in 2-dimensions and 3-dimensions. The group with greater correction to the cranial deformity would be considered the more impactful treatment method.
Compliance with treatment
Overall compliance with each treatment method will be assessed.
Caregivers of affected infants will be given surveys at each follow up appointment to assess adherence to the treatment arm's protocol. Surveys will include questions specific to the infant's treatment arm, which may include questions such as how long the child remains in a repositioned position before moving themselves, how many hours per day the infant is wearing their custom helmet, and how often caregivers are performing the recommended neck stretches.
No surveys will be given to the typically-developing control group as there is no active treatment for this group.
Full Information
NCT ID
NCT05917678
First Posted
June 5, 2023
Last Updated
August 18, 2023
Sponsor
University of Texas Southwestern Medical Center
Collaborators
Children's Health
1. Study Identification
Unique Protocol Identification Number
NCT05917678
Brief Title
Effectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation
Official Title
Effectiveness of Repositioning, Physical Therapy, and Cranial Remolding in Infants With Cranial Deformation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2023 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
Children's Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deformational Plagiocephaly, Deformational Posterior Plagiocephaly, Brachycephaly, Torticollis, Congenital Muscular Torticollis
Keywords
plagiocephaly, brachycephaly, asymmetrical brachycephaly, helmet, cranial remolding, orthosis, repositioning, deformational, torticollis, normal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
65 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Repositioning Therapy
Arm Type
Other
Arm 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.
Arm Title
Repositioning Therapy + Cranial Remolding Orthoses
Arm Type
Other
Arm 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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Healthy infants without deformational head shapes or need for physical therapy will be followed and measured. No intervention.
Intervention Type
Other
Intervention Name(s)
Repositioning Therapy
Intervention Description
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
Device
Intervention Name(s)
Cranial Remolding Orthosis
Other Intervention Name(s)
Helmet, Cranial Band, STARband
Intervention Description
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 Measure Information:
Title
Final Head Shape
Description
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.
Time Frame
10 months after enrollment (at 12 months of age)
Secondary Outcome Measure Information:
Title
Overall Change in Head Shape
Description
The improvements seen in each of the 2 treatment arms will be compared to determine if one treatment has a greater impact than the other treatment.
Specifically, the difference between the baseline measurements (taken at 2 months of age) and the updated measurements (taken at each study measurement timepoint) will be compared in 2-dimensions and 3-dimensions. The group with greater correction to the cranial deformity would be considered the more impactful treatment method.
Time Frame
Assessment to occur within 2 years of enrollment closure.
Title
Compliance with treatment
Description
Overall compliance with each treatment method will be assessed.
Caregivers of affected infants will be given surveys at each follow up appointment to assess adherence to the treatment arm's protocol. Surveys will include questions specific to the infant's treatment arm, which may include questions such as how long the child remains in a repositioned position before moving themselves, how many hours per day the infant is wearing their custom helmet, and how often caregivers are performing the recommended neck stretches.
No surveys will be given to the typically-developing control group as there is no active treatment for this group.
Time Frame
Assessment to occur within 2 years of enrollment closure.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tiffany Graham, MSPO
Phone
214-645-8250
Email
Tiffany.Graham@utsouthwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiffany Graham
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiffany Graham, MSPO
Phone
214-645-8250
Email
Tiffany.Graham@utsouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Rami Hallac, PhD
First Name & Middle Initial & Last Name & Degree
Jijia Wang, PhD
First Name & Middle Initial & Last Name & Degree
Alex Kane, MD
First Name & Middle Initial & Last Name & Degree
Caitlin Deville, DSc
First Name & Middle Initial & Last Name & Degree
Susan Simpkins, EdD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No identifiable data will be shared outside of the study investigators.
Learn more about this trial
Effectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation
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