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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment for flat head syndrome?

Research shows that helmet therapy can be effective in correcting moderate to severe cases of flat head syndrome (plagiocephaly) in infants, with both actual improvements and positive parental perceptions reported. ^{1 2 3 4 5}

Is helmet therapy safe for treating flat head syndrome in infants?

Helmet therapy is generally safe, but minor complications like pressure sores, skin redness, and infections can occur in about 26% of cases. Children with a combination of different head shape issues may have a higher risk of these minor problems. ^{1 2 4 6 7}

How does helmet therapy for flat head syndrome differ from other treatments?

Helmet therapy is unique because it is a non-surgical treatment specifically designed to gently shape an infant's skull over time, addressing cranial asymmetry and mid-facial asymmetry, which other treatments may not target as effectively. ^{1 2 7 8 9}

Research Team

Tiffany Graham

Principal Investigator

University of Texas Southwestern Medical Center

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 (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]

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]

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]

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]

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]

References

1. United States 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. [2023]

2. United States 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. [2023]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

Parents' Perspectives and Clinical Effectiveness of Cranial-Molding Orthoses in Infants With Plagiocephaly. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Deformational posterior plagiocephaly: diagnosis and treatment. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Treatment of plagiocephaly with helmet molding therapy: do actual results mimic perception? [2011]

6. United States pubmed.ncbi.nlm.nih.gov

The Incidence of Complications Associated With Molding Helmet Therapy: An Avoidable Risk in the Treatment of Positional Head Deformities? [2018]

7. England pubmed.ncbi.nlm.nih.gov

HElmet therapy Assessment in infants with Deformed Skulls (HEADS): protocol for a randomised controlled trial. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Does helmet therapy influence the ear shift in positional plagiocephaly? [2015]

9. Germany pubmed.ncbi.nlm.nih.gov

Three-dimensional analysis of cranial and facial asymmetry after helmet therapy for positional plagiocephaly. [2018]