Repositioning + Helmet Therapy for Flat Head Syndrome

Overseen By Tiffany Graham, MSPO

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Abnormal head shapes, Growth abnormalities, Developmental delay

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

65 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to assist babies with flat head syndrome. It tests whether changing a baby's position (Repositioning Therapy) can improve head shape and whether a special custom helmet (Cranial Remolding Orthosis) offers additional benefits. Babies with neck muscle tightness (torticollis) will receive physical therapy. Babies with an unusual head shape or frequent need for physical therapy might be suitable for this trial. Additionally, a group of healthy babies is being studied to observe natural head growth. As an unphased trial, this study provides a unique opportunity to enhance understanding and treatment of flat head syndrome in infants.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that these treatments are safe for infants?

Research shows that both repositioning therapy and helmets safely treat flat head syndrome in babies. Repositioning therapy involves changing the baby's position to help shape their head and is commonly used without major safety issues.

For helmets, studies have found them necessary and safe for babies with more noticeable head shape issues. Evidence supports their effectiveness and safety, with no major problems reported. Helmets are usually adjusted every few weeks and worn most of the day to help the head grow into the right shape.

Both treatments are well-tolerated. The FDA has approved helmet therapy for babies with unusual head shapes, further confirming its safety. Overall, both treatments are safe options for managing flat head syndrome in babies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for repositioning and helmet therapy for flat head syndrome because it explores a combined approach that might offer faster and more effective results. Traditionally, treatments for flat head syndrome include repositioning therapy, where infants are repositioned during sleep to encourage natural head shape correction, and cranial remolding orthoses, which involve wearing a custom-fitted helmet to guide skull growth. This trial investigates using both methods together, starting with repositioning therapy and transitioning to helmet therapy if needed. By doing this, the hope is to optimize skull growth and shape correction, potentially reducing the time infants need to wear helmets and improving overall outcomes.

What evidence suggests that repositioning therapy and cranial remolding orthosis are effective for flat head syndrome?

This trial will compare Repositioning Therapy alone with Repositioning Therapy combined with Cranial Remolding Orthoses for flat head syndrome. Studies have shown that repositioning therapy can correct flat spots on a baby's head by encouraging natural growth. This method involves changing the baby's position during sleep and play to relieve pressure on the flattened area. Research indicates that cranial remolding orthoses, or special helmets, effectively treat flat head syndrome, especially when used before the baby is 9 months old. These helmets gently shape the baby's head as it grows and are typically worn most of the day. Evidence supports both repositioning and helmets as effective treatments for flat head syndrome in babies. ^{2 6 7 8 9}

Who Is on the Research Team?

Tiffany Graham

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for healthy infants with normal development who have flat head syndrome or torticollis but don't need physical therapy. Infants with abnormal head shapes, growth abnormalities, genetic conditions, or significant developmental delays requiring therapy cannot participate.

Inclusion Criteria

My infant is healthy with normal physical development and doesn't need physical therapy.

Exclusion Criteria

My child needs physical or occupational therapy due to developmental delays.

My infant has an abnormal head shape.

My infant has a genetic condition affecting their growth.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Repositioning Therapy

Infants begin repositioning therapy and physical therapy if torticollis is present. Follow-ups occur at least monthly.

2-4 months

Monthly visits (in-person)

Cranial Remolding Orthosis

Infants with unresolved head shape issues may opt for cranial remolding orthosis treatment, adjusted every few weeks.

Up to 8 months

Visits every few weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment. Final evaluation at 12 months of age.

10 months after enrollment

Final visit at 12 months of age (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Cranial Remolding Orthosis
• Repositioning Therapy

Trial Overview The study tests how well caregiver-led repositioning helps correct an infant's cranial shape and the effectiveness of a custom-made cranial remolding orthosis. It includes infants with torticollis receiving physical therapy and compares their growth to unaffected peers.

How Is the Trial Designed?

Group I: Repositioning Therapy + Cranial Remolding Orthoses Experimental Treatment 2 Interventions

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.

Group II: Repositioning Therapy Experimental Treatment 1 Intervention

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.

Group III: Control Active Control 1 Intervention

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

Cranial Remolding Orthosis is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Cranial Remolding Orthosis for:

• Deformational Plagiocephaly
• Brachycephaly
• Scaphocephaly
• Post-Operative Craniosynostosis

Approved in European Union as Cranial Remolding Orthosis for:

• Deformational Plagiocephaly
• Brachycephaly
• Scaphocephaly

Approved in Canada as Cranial Remolding Orthosis for:

• Deformational Plagiocephaly
• Brachycephaly
• Scaphocephaly

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Children's Health

Collaborator

Trials

8

Recruited

460+

Published Research Related to This Trial

Helmet therapy (DOC band) significantly reduced cranial vault asymmetry by 41.56% and cranial base asymmetry by 40.23% in infants with moderate to severe posterior deformational plagiocephaly, based on a study of 125 patients.

The timing of treatment initiation before 1 year of age did not significantly affect the outcomes, indicating that compliance with helmet usage was the key factor in achieving effective results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deformational posterior plagiocephaly: diagnosis and treatment. Teichgraeber, JF., Ault, JK., Baumgartner, J., et al.[2018]

Helmet molding therapy for deformational plagiocephaly significantly improves parents' perceptions of their children's head shape and ear position, with parent ratings increasing from an average of 2.99 to 7.88 for head shape and from 3.75 to 7.73 for ear position after treatment.

While parents perceive substantial improvements, actual measurements from topographic scans show only modest changes in head shape, indicating the importance of managing expectations for treatment outcomes among parents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of plagiocephaly with helmet molding therapy: do actual results mimic perception? Katzel, EB., Koltz, PF., Sbitany, H., et al.[2011]

A systematic review of 15 studies indicates that cranial-molding orthosis (helmet) therapy leads to more significant and faster improvements in head shape for infants with positional plagiocephaly compared to conservative treatments, especially in cases of severe deformity.

The effectiveness of helmet therapy is enhanced when treatment begins early in infancy, although specific guidelines on the best timing and measurement criteria for treatment remain unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Congress of Neurological Surgeons Systematic Review and Evidence-Based Guideline on the Role of Cranial Molding Orthosis (Helmet) Therapy for Patients With Positional Plagiocephaly. Tamber, MS., Nikas, D., Beier, A., et al.[2023]

Helmet therapy significantly improves ear position in infants with severe positional plagiocephaly, with a mean improvement of 29.8% in ear shift observed in 60 infants (P < 0.001).

While helmet therapy effectively addresses ear shift, clinical observations regarding ear position changes are not reliable compared to three-dimensional measurements, indicating a need for more precise evaluation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does helmet therapy influence the ear shift in positional plagiocephaly? Kluba, S., Schreiber, R., Kraut, W., et al.[2015]

In a study of 205 children undergoing molding helmet therapy for positional head deformities, 26.3% experienced minor complications, including pressure sores and skin infections.

Children with a combination of plagiocephaly and brachycephaly had a significantly higher risk of complications (50%) compared to those with only plagiocephaly (22.3%), suggesting that closer monitoring and adjustments may help reduce these risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Incidence of Complications Associated With Molding Helmet Therapy: An Avoidable Risk in the Treatment of Positional Head Deformities? Freudlsperger, C., Bodem, JP., Kargus, S., et al.[2018]

A systematic review of 15 studies indicates that cranial-molding orthosis (helmet) therapy leads to more significant and faster improvements in head shape for infants with positional plagiocephaly compared to conservative treatments, especially in cases of severe deformity.

The effectiveness of helmet therapy is enhanced when treatment begins early in infancy, although specific guidelines on the best timing and measurement criteria for treatment remain unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guidelines: Congress of Neurological Surgeons Systematic Review and Evidence-Based Guideline on the Role of Cranial Molding Orthosis (Helmet) Therapy for Patients With Positional Plagiocephaly. Tamber, MS., Nikas, D., Beier, A., et al.[2023]

Cranial-molding orthoses were used effectively in 82 infants with plagiocephaly, showing significant improvement in skull shape as measured by the Cranial Vault Asymmetry Index (CVAI), with a compliance rate of 90.2%.

Despite a high occurrence of adverse events (65% of infants), primarily heat rash, 71.6% of parents reported satisfaction with the treatment outcomes, indicating that parents' perceptions of success were linked to measurable improvements in their infants' skull asymmetry.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parents' Perspectives and Clinical Effectiveness of Cranial-Molding Orthoses in Infants With Plagiocephaly. Lee, HS., Kim, SJ., Kwon, JY.[2020]

Helmet therapy is an effective non-surgical treatment for positional plagiocephaly, significantly improving cranial and mid-facial asymmetries in infants, particularly those treated before 1 year of age.

In a study of 99 patients, both cranial vault asymmetry and mid-facial soft tissue asymmetry showed marked improvement after helmet therapy, indicating its efficacy across different age groups, with the best results seen in younger patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-dimensional analysis of cranial and facial asymmetry after helmet therapy for positional plagiocephaly. Lee, MC., Hwang, J., Kim, YO., et al.[2018]

The HEADS study is a randomized controlled trial involving infants with moderate to severe skull deformation, aiming to assess the effectiveness of helmet therapy compared to no treatment, with follow-up assessments at 8, 12, and 24 months.

This study will provide the first rigorous evidence on helmet therapy's impact on head shape and parental satisfaction, which could influence treatment policies and insurance reimbursement decisions in the Netherlands.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HElmet therapy Assessment in infants with Deformed Skulls (HEADS): protocol for a randomised controlled trial. van Wijk, RM., Boere-Boonekamp, MM., Groothuis-Oudshoorn, CG., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12384474/

A 10-Year Review of the Efficacy of Cranial Remolding ... Highlights · Cranial remolding orthoses (CROs) are an effective, evidence-backed treatment for isolated deformational plagiocephaly in infants.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10764669/

Effectiveness of Helmet therapy for infants with moderate to ... Starting helmet treatment before 9 months and wearing it over 15 hours daily yielded better outcomes.

3. mdpi.com mdpi.com/2077-0383/13/19/5952

Therapeutic Effectiveness of a Novel Cranial Remolding ... This study aimed to evaluate the efficacy and safety of a novel cranial remolding helmet (baby band2) for positional plagiocephaly using 3D data ...

4. cns.org cns.org/guidelines/browse-guidelines-detail/5-role-of-cranial-molding-orthosis-helmet-therapy

5. The Role of Cranial Molding Orthosis (Helmet) Therapy The purpose of this systematic review is to address the clinical question: Does helmet therapy provide effective treatment for positional plagiocephaly? METHODS.

5. aetna.com aetna.com/cpb/medical/data/300_399/0379.html

Cranial Remodeling - Medical Clinical Policy Bulletins Aetna considers cranial remodeling bands (or helmets) as medically necessary orthoses for treatment of moderate-to-severe positional head deformities.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6723372/

Effects of Initial Age and Severity on Cranial Remolding ... The aim of this study is to review the effects of an infant's presenting age and severity of deformation on cranial remolding orthotic (CRO) treatment outcomes.

7. mdpi.com mdpi.com/2227-9067/12/8/1099

A 10-Year Review of the Efficacy of Cranial Remolding ... Cranial remolding orthoses (CROs) are an effective, evidence-backed treatment for isolated deformational plagiocephaly in infants. Treatment efficacy has a ...

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf12/K124023.pdf

K 124023 - STARband® Cranial Orthosis - accessdata.fda.gov The STARband is designed to treat infants with abnormal head shapes from age 3 months to 18 months and is available by prescription only. Since ...

9. oandplabinc.com oandplabinc.com/cranial-orthotics.html

Cranial Remolding Orthosis (Helmets) The head is encouraged to grow into the lose areas of the helmet, allowing the flattened parts of the head to "catch up" with the prominent areas.