Deformational PlagiocephalyNCT05917678
Effectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation
A study testing Repositioning Therapy and Cranial Remolding Orthosis in people with Deformational Plagiocephaly and Deformational Posterior Plagiocephaly, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Deformational Plagiocephaly, Deformational Posterior Plagiocephaly, Brachycephaly
- What is being tested?
- Repositioning Therapy and Cranial Remolding Orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2023to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 3 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants with normal physical development and no need for physical therapy intervention
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Tiffany Graham, MSPO, 214-645-8250, Tiffany.Graham@utsouthwestern.edu
Rami Hallac, PhD
About this study
Official title: Effectiveness of Repositioning, Physical Therapy, and Cranial Remolding in Infants With Cranial Deformation
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.
Read the 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
- Being tested
- Repositioning Therapy, Cranial Remolding Orthosis
- Keywords
- plagiocephaly, brachycephaly, asymmetrical brachycephaly, helmet, cranial remolding, orthosis, repositioning, deformational, torticollis, normal
- Medical subject headings
- Plagiocephaly, Nonsynostotic, Craniosynostoses, Torticollis, Congenital torticollis, Plagiocephaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repositioning TherapyOther
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 OrthosisDevice
Also called Helmet, Cranial Band, STARband
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 months after enrollment (at 12 months of age)
Secondary outcomes (2)
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.
Measured: Assessment to occur within 2 years of enrollment closure.
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.
Measured: Assessment to occur within 2 years of enrollment closure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start23 May 2023
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deformational PlagiocephalyStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Health
- Responsible party
- Principal investigator, Tiffany Graham, University of Texas Southwestern Medical Center
- Investigators
- Tiffany Graham, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917678
- Sponsor's protocol ID
- STU 032017-036
- Status last verified
- Aug 2026
- First submitted
- 5 Jun 2023
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No identifiable data will be shared outside of the study investigators.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Repositioning, Physical Therapy, and Cranial Remolding in Infants With Cranial Deformation
- ClinicalTrials.gov ID
- NCT05917678
- Acronym / sponsor ID
- STU 032017-036
- Conditions
- Deformational Plagiocephaly, Deformational Posterior Plagiocephaly, Brachycephaly, Torticollis, Congenital Muscular Torticollis
- Keywords
- plagiocephaly, brachycephaly, asymmetrical brachycephaly, helmet, cranial remolding, orthosis, repositioning, deformational
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Children's Health
- Study start
- 23 May 2023 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 26 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Repositioning Therapy | Other | Other: Repositioning TherapyInfants 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. |
| Repositioning Therapy + Cranial Remolding Orthoses | Other | Other: Repositioning Therapy, Device: Cranial Remolding OrthosisAfter 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. |
| Control | No intervention | –Healthy infants without deformational head shapes or need for physical therapy will be followed and measured. No intervention. |
Who may qualify
- Ages
- 2 to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy infants with normal physical development and no need for physical therapy intervention
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repositioning TherapyCaregivers 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. | Other | Repositioning Therapy, Repositioning Therapy + Cranial Remolding Orthoses |
| Cranial Remolding OrthosisAlso: Helmet, Cranial Band, STARbandA 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. | Device | Repositioning Therapy + Cranial Remolding Orthoses |
Primary outcome
Final Head Shape
Time frame: 10 months after enrollment (at 12 months of age)
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.
2 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No. No identifiable data will be shared outside of the study investigators.
Related trials for Deformational Plagiocephaly
Not yet recruiting
Effects of Tummy Time Associated With Therapeutic Positioning in Premature Newborns With Cranial Asymmetry
Premature Newborns, Cranial Asymmetry
Recruiting
OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates
Plagiocephaly, Nonsynostotic, Plagiocephaly, Positional
Not yet recruitingObservational study
Head Circumference Evolution in Children With Positional Plagiocephaly During and After Molding Helmet Therapy.
Non Synostotic Plagiocephaly
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tiffany Graham principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repositioning Therapy and Cranial Remolding Orthosis in people with Deformational Plagiocephaly and Deformational Posterior Plagiocephaly, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tiffany Graham, MSPO (214-645-8250, Tiffany.Graham@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Final Head Shape (time frame: 10 months after enrollment (at 12 months of age)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.