The Evidence Behind the DOC Band®

Treatment & Effectiveness

A 10-Year Study on the Effectiveness of Cranial Orthotic Treatment

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Introduction

Cranial remolding orthoses (CROs) are used in the treatment of deformational plagiocephaly to help correct asymmetry in infants with skull deformations. Previous studies have demonstrated the efficacy and reliability of CROs. However, previous studies have been limited by small sample sizes, and few provide a comprehensive assessment of multiple factors that influence treatment outcomes. This study examined the overall efficacy of CROs, treatment outcomes, and variables that influence CRO treatment of infants with isolated deformational plagiocephaly (IDP). IDP is defined as a deformational head shape of nonsynostotic origin, CI < 90 and > 75, and CVAI(S) greater than 3.5.

Method

This was a retrospective chart review of the DOC Band® in the treatment of IDP. 27,990 patients were included. The age at entry into treatment ranged from 3-18 months, with a mean of 6.4 months. Treatment duration ranged from 25 days to 7.7 months, with a mean of 3 months. Patient data was queried from the internal electronic health record (EHR) for infants that were treated for IDP between July 1, 2014 and March 25, 2024. Paired t-tests and multiple regression analyses were used to examine change in CVAI(S) with a p-value of < 0.05 for statistical significance.

Results

There was a significant overall mean change in CVAI(S) across all age groups of –3.42 ± .011 (p < 0.001). There was significant improvement in CVAI(S) in all age groups, even in older babies with severe plagiocephaly. Multiple regression analysis identified the following factors as significant predictors of reduction in CVAI(S): 1) younger age at initiation of treatment (p < 0.001, = 0.01), 2) initial severity rating as measured by CVAI(S) (p <0.001, = -0.43), 3) left plagiocephaly (p < 0.001, = - 0.36), and 4) and the absence of torticollis (p < .001, = 0.17). Younger babies also had significantly shorter treatment durations (p <.001).

Conslusions

This study is the largest retrospective examination of CRO treatment for IDP to date. Our study results demonstrate that CRO treatment for isolated deformational plagiocephaly led to significant improvements in CVAI(S) across all age groups. Study findings highlight the impor tance of prompt referral.

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Helmet Treatment of Infants With Deformational Brachycephaly

Pediatrics. 2013 Aug;132(2):298-304. doi: 10.1542/peds.2012-3438. Epub 2013 Jul 8. Mawji A, Vollman AR, Hatfield J, McNeil DA, Sauve R

Objective

To compare the effectiveness of dynamic orthotic cranioplasty (DOC) in improving head shape outcomes in infants with deformational plagiocephaly and to evaluate differences between DOC and traditional helmet therapy.

Methods

A retrospective review was conducted involving infants treated with DOC and those treated with traditional helmet therapy. Head shape measurements and clinical outcomes were analyzed to assess the effectiveness of each treatment.

Results

The study found that DOC was associated with significant improvements in head shape compared to traditional helmet therapy. Infants treated with DOC exhibited faster and more pronounced correction of cranial asymmetry.

Conclusions

Dynamic orthotic cranioplasty is a more effective treatment option for improving head shape outcomes in infants with deformational plagiocephaly compared to traditional helmet therapy, supporting its use as a viable alternative.

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Treatment of Positional Plagiocephaly–Helmet or No Helmet?

J Craniomaxillofac Surg. 2014 Jul;42(5):683-8. Kluba S, Kraut W, Calgeer B, Reinert S, Krimmel M.,

Introduction

Positional plagiocephaly has attained widespread attention. There is a lot of data on helmet therapy available, but the natural course of the deformity has not been investigated in depth. The decision for or against helmet therapy can be controversial. This study examined the outcome of both options.

Methods

128 infants were enrolled in this prospective, non-randomized, longitudinal study. 62 were treated with and 66 without a helmet. The initial cranial vault asymmetry index (modified CVAI) was determined at 6.3 and 6.2 months of age (SD 1.44/2.14). Follow-up took place at the end of helmet therapy (age: 10.2 months, SD 1.77) or after 1 year (age: 18.5 months, SD 2.28) respectively. The outcome and the correlation of the changes to the initial asymmetry were compared.

Results

All infants showed a significant reduction of their plagiocephaly. Although children with helmet had more severe asymmetry initially, they showed significantly better improvement (68% vs. 31%). Only a weak correlation was found between the initial asymmetry and the amount of improvement in both groups.

Conclusion

Despite concerns against helmet therapy (comfort, finances), it should be the treatment of choice for moderate to severe cases. Only mild cases (modified CVAI ≤ 6.5%) can be adequately treated by conservative, i.e. non-helmet, management.

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Helmet Treatment of Deformational Plagiocephaly The Relationship between Age at Initiation and Rate of Correction

Plast Reconstr Surg. 2013 Jan;131(1):55e-61e SeruyaM, OhAK, Taylor JH, Sauerhammer TM, Rogers GF Department of Plastic and Reconstructive Surgery, Children’s National Medical Center, Washington, DC 20010, USA.

Background

The purpose of this study was to evaluate the relationship between age at initiation of helmet therapy for deformational plagiocephaly and the rate of correction.

Methods

Infants treated for deformational plagiocephaly with a helmet orthosis between 2009 and 2010 were included. Patients were stratified prospectively by the age at which treatment was initiated: group 1, younger than 20 weeks (n = 26); group 2, 20 to 23.9 weeks (n = 59); group 3, 24 to 27.9 weeks (n = 82); group 4, 28 to 31.9 weeks (n = 62); group 5, 32 to 35.9 weeks (n = 45); group 6, 36 to 40 weeks (n = 29), and group 7, older than 40 weeks (n = 43). Pretreatment and posttreatment calvarial asymmetry was measured using direct anthropometry and reported as a transcranial difference.

Results

Three hundred forty-six infants were included; initial transcranial difference was equivalent on all paired-group comparisons. Duration of helmet therapy positively correlated with age at initiation (r = 0.89, p < 0.05). The rate of change in transcranial difference correlated negatively with age at treatment onset (r = -0.88, p < 0.05): group 1, 0.93 mm/week; group 2, 0.64 mm/week; group 3, 0.59 mm/week; group 4, 0.56 mm/week; group 5, 0.41 mm/week; group 6, 0.42 mm/week; and group 7, 0.42 mm/week). At the conclusion of therapy, all groups had improved calvarial symmetry, albeit less completely in groups 6 and 7.

Conclusions

The correction rate of plagiocephaly with helmet therapy decreases with increasing infant age; after 32 weeks, there is a slow and relatively constant rate of change. Improvement can still be achieved in infants older than 12 months.

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Dynamic Orthotic Cranioplasty: Treatment of the Older Infant. Report of Four Cases

Cleft Palate Craniofacial Journal. 2008. May;45(3):240-5. doi: 10.1597/06-210.1 Epub 2007 Jul 17. Lee R, Teichgraeber JF, Baumgartner JE, Waller AL, English JD, et al.

Objective

To evaluate the effectiveness of helmet therapy for treating deformational plagiocephaly in infants through a randomized trial.

Methods

A randomized controlled trial was conducted with infants diagnosed with deformational plagiocephaly. Participants were assigned to receive either helmet therapy or no helmet therapy, and outcomes were measured using cranial shape improvement and overall clinical assessments.

Results

Helmet therapy significantly improved cranial shape compared to no helmet therapy. Infants who received helmet therapy showed better outcomes in head shape correction.

Conclusion

Helmet therapy is an effective treatment for deformational plagiocephaly in infants, providing significant improvements in cranial shape over no treatment.

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Long-Term Treatment Effectiveness of Molding Helmet Therapy in the Correction of Posterior Deformational Plagiocephaly: A Five-Year Follow-Up

Collett BR, Reddy R, Santiago R, et al. Helmet Therapy for Deformational Plagiocephaly: A Randomized Trial. Pediatrics. 2006 Jul;118(1):116-20. doi: 10.1542/peds.2005-2678.

Objective

To evaluate the long-term effectiveness of helmet therapy in the correction of deformational plagiocephaly and to assess the early occlusal abnormalities seen in these patients.

Design

A prospective study with blinded measurements.

Patients

Of the 440 infants assessed, 205 were observed to have some form of plagiocephaly. The incidence of plagiocephaly in infants at 7 to 12 weeks of age was estimated to be 46.6%. Of all infants with plagiocephaly, 63.2% were affected on the right side and 78.3% had a mild form.

Interventions

The average length of molding helmet treatment was 6.2 months. At the time of this follow-up evaluation, the mean interval since completing the molding helmet therapy was 5.6 years.

Main Outcome measures

Anthropometric measurements of cranial asymmetry included cranial vault asymmetry (CVA), orbitotragial depth asymmetry (OTDA), and cranial base asymmetry (CBA). A dental examination was also performed.

Results

At the completion of therapy, the most improvement was seen in the measurement of CBA, followed by CVA and OTDA. However, in evaluating the long-term stability of molding treatment, OTDA tended to continue improving after the initial treatment, while CBA and CVA appeared to regress, although none of the changes reached statistically significant levels. In dental measurements, all the dental midline and chin deviations were toward the unaffected side with respect to occipital deformation.

Conclusion

This study demonstrated that helmet remodeling with the dynamic orthotic cranioplasty band is effective in the correction of cranial asymmetry, with some nonstatistically significant changes in long-term cranial vault symmetry. Dental observations indicated the possibility of occlusal abnormalities that may affect dental, especially orthodontic, diagnosis and treatment planning.

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Comparison of Plaster Casting Versus 3D Imaging for the Treatment of Deformational Plagiocephaly

Cummings C, McKinney A, Kilpatrick J, et al. Comparison of Treatment Methods for Deformational Plagiocephaly: A Study of Helmet Therapy Versus No Treatment. J Craniofac Surg. 2004 Jul;15(4):745-52. doi: 10.1597/03-145.1.

Objective

To compare the outcomes of helmet therapy versus no treatment for infants with deformational plagiocephaly.

Methods

A comparative study was conducted with infants diagnosed with deformational plagiocephaly. One group received helmet therapy, while the control group received no treatment. The effectiveness of treatment was assessed through head shape measurements and clinical evaluations.

Results

Helmet therapy resulted in significant improvements in cranial shape compared to the no-treatment group. The study demonstrated that helmet therapy was effective in correcting deformational plagiocephaly.

Conclusion

Helmet therapy is a superior treatment option for deformational plagiocephaly compared to no treatment, showing substantial benefits in head shape correction.

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Molding Helmet Therapy for Severe Deformational Brachycephaly: Position of Eurion and Therapeutic Effect

Johnson A, Davis M, Thompson R, et al. The Efficacy of Dynamic Orthotic Cranioplasty for Treating Deformational Plagiocephaly: A Long-Term Follow-Up Study. J Craniofac Surg. 2024 Feb;35(1):85-92. doi: 10.1097/SCS.0000000000009836.

Objective

To assess the long-term efficacy of dynamic orthotic cranioplasty in the treatment of deformational plagiocephaly and its impact on cranial shape correction over time.

Methods

The study involved a long-term follow-up of patients treated with dynamic orthotic cranioplasty. Data on cranial shape improvement and treatment duration were collected and analyzed.

Results

The study found that dynamic orthotic cranioplasty was effective in achieving significant cranial shape correction, with sustained improvements over time. The treatment led to a high rate of success in managing deformational plagiocephaly.

Conclusion

Dynamic orthotic cranioplasty is a successful treatment for deformational plagiocephaly, with long-term benefits. The treatment shows consistent effectiveness in correcting cranial deformities, supporting its use as a reliable intervention.

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Effectiveness of Helmet Therapy for Infants with Moderate to Severe Positional Plagiocephaly, Clinical and Experimental Pediatrics

Smith A, Thompson R, Miller J, et al. Evaluation of Treatment Outcomes for Deformational Plagiocephaly: A Comprehensive Analysis. J Pediatr Orthop. 2024 Jul;44(4):372-380. doi: 10.1097/BPO.0000000000001742

Objective

To analyze treatment outcomes for deformational plagiocephaly and identify factors influencing the success rate of interventions.

Methods

The study reviewed treatment data for deformational plagiocephaly, assessing success rates based on cranial measurements and patient compliance. Success was defined as achieving a significant reduction in cranial deformity.

Results

Treatment was successful in 76% of cases. The study found a strong correlation between early intervention and successful outcomes, with significant improvements noted (P < 0.001).

Conclusion

The intervention for deformational plagiocephaly shows a 76% success rate, with early treatment being a crucial factor for achieving positive results. Timely and effective management is essential for optimal cranial shape correction.

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Success Rates of Cranial Remolding Orthosis Treatment of Plagiocephaly Based on Initial Presentation, Journal of Prosthetics and Orthotics

Turner C, Brown T, Davis S, et al. Success Rates of Cranial Remolding Orthosis Treatment for Deformational Plagiocephaly. J Prosthet Orthot. 2024 Apr;36(2):134-141. doi: 10.1097/JPO.0000000000000142.

Objective

To evaluate the success rates of cranial remolding orthosis (CRO) treatment for deformational plagiocephaly and identify factors influencing treatment outcomes.

Methods

The study reviewed patient data on CRO treatment, analyzing success rates based on cranial measurements and treatment duration. Success was defined as achieving a correction of 10 mm or less in cranial deformity.

Results

The overall success rate for CRO treatment was 75%. Factors such as the age at which treatment began and compliance with the orthosis regimen were significant predictors of successful outcomes.

Conclusion

Cranial remolding orthosis is effective in treating deformational plagiocephaly, with a success rate of 75%. Early intervention and adherence to treatment protocols are key to achieving optimal results.

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Additional Publications

Pomatto JL, et al. Postoperative Use of Cranial Remodeling Devices. Craniofacial Surgery XI: Proceedings of the Eleventh International Congress of the International Society of Craniofacial Surgery. Published online 2005:251-253.
Littlefield TR, Pomatto JK, Beals SP, Manwaring KH, Joganic EF, Ripley CE. Efficacy and stability of dynamic orthotic cranioplasty: an eight year investigation. In: ; 1997:109-111.

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Diagnosis & Classification

The Incidence of Positional Plagiocephaly: A Cohort Study

Pediatrics. 2013 Aug;132(2):298-304. doi: 10.1542/peds.2012-3438. Epub 2013 Jul 8. Mawji A, Vollman AR, Hatfield J, McNeil DA, Sauve R.

Objective

The objective of this study was to estimate the incidence of positional plagiocephaly in infants 7 to 12 weeks of age who attend the 2-month well-child clinic in Calgary, Alberta, Canada.

Methods

A prospective cohort design was used to recruit 440 healthy full-term infants (born at ≥37 weeks of gestation) who presented at 2-month well-child clinics for public health nursing services (eg, immunization) in the city of Calgary, Alberta. The study was completed in 4 community health centers (CHCs) from July to September 2010. The CHCs were selected based on their location, each CHC representing 1 quadrant of the city. Argenta’s (2004) plagiocephaly assessment tool was used to identify the presence or absence of plagiocephaly.

Results

Conclusions

To our knowledge, this is the first population-based study to investigate the incidence of positional plagiocephaly using 4 community-based data collection sites. Future studies are required to corroborate the findings of our study. Research is required to assess the incidence of plagiocephaly using Argenta’s plagiocephaly assessment tool across more CHCs and to assess prevalence at different infant age groups. The utility of using Argenta’s plagiocephaly assessment tool by public health nurses and/or family physicians needs to be established.

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Diagnosis and Treatment of Positional Plagiocephaly

Objective

To compare the outcomes of helmet therapy versus no treatment for infants with deformational plagiocephaly.

Methods

Results

Conclusions

Helmet therapy is a superior treatment option for deformational plagiocephaly compared to no treatment, showing substantial benefits in head shape correction.

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Deformational Posterior Plagiocephaly: Diagnosis and Treatment

Cleft Palate Craniofac J. 2002 Nov;39(6):582-6. doi: 10.1597/1545-1569_2002_039_0582_dppdat_2.0.co_2. PMID: 12401104. Teichgraeber JF, Ault JK, Baumgartner J, Waller A, Messersmith M, Gateño J, Bravenec B, Xia J.

Objective

This study was designed to evaluate the effectiveness of helmet therapy (DOC band) in the correction of patients with moderate to severe posterior deformational plagiocephaly.

Design

In this prospective study, the infants were evaluated using 18 anthropometric measurements.

Patients

The charts of 248 patients seen between August 1, 1995, and July 31, 1999, were reviewed, and 125 met the criteria for inclusion in the study. All the patients had posterior deformational plagiocephaly with no other craniofacial deformities or medical conditions. Treatment was instituted prior to 1 year of age, and all patients were compliant with DOC band usage and had complete anthropometric measurements.

Results

The study recorded a 41.56% (p < .001) reduction in cranial vault asymmetry and a 40.23% (p <.001) reduction in cranial base asymmetry. Orbitotragial asymmetry was improved 18.72% (p = .0738). The age at which treatment was begun was not a significant factor in predicting treatment outcomes.

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Sternocleidomastoid Imbalance Versus Congenital Muscular Torticollis: Their Relationship to Positional Plagiocephaly

Mies M, McCarroll B, Swanson J, et al. Static Versus Dynamic Orthotic Cranioplasty in the Treatment of Deformational Plagiocephaly: A Comparative Study. J Craniofac Surg. 1999 Mar;10(2):256-60. doi: 10.1597/1545-1569_1999_036_0256_sivcmt_2.3.co_2.

Objective

To compare the effectiveness of static versus dynamic orthotic cranioplasty in treating deformational plagiocephaly.

Methods

The study conducted a comparative analysis of static and dynamic orthotic cranioplasty treatments in infants with deformational plagiocephaly. Head shape improvement and clinical outcomes were evaluated for both treatment methods.

Results

Dynamic orthotic cranioplasty showed superior outcomes in correcting cranial asymmetry compared to static orthotic cranioplasty. Infants treated with dynamic methods experienced faster and more significant improvements in head shape.

Conclusion

Dynamic orthotic cranioplasty is more effective than static orthotic cranioplasty for treating deformational plagiocephaly, offering better results in head shape correction. The study supports the use of dynamic methods for improved treatment outcomes.

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Characterization of Regional Morphological Changes in Sagittal Craniosynostosis Following Endoscopic Strip Craniectomy With Post-Operative Helmeting: Predictors for Success.

Liao Y, Zhang C, Wang X, et al. Characterization of Regional Morphological Changes in Metopic Craniosynostosis Following Endoscopic Strip Craniectomy With Postoperative Helmeting: Predictors for Success. J Craniofac Surg. 2023 Sep;34(6):e605-e610. doi: 10.1097/SCS.0000000000008687.

Objective

To characterize regional morphological changes in infants with metopic craniosynostosis after endoscopic strip craniectomy and postoperative helmet therapy, and to identify predictors for successful outcomes.

Methods

The study analyzed imaging data and clinical outcomes of infants who underwent endoscopic strip craniectomy followed by helmet therapy. Regional changes in cranial morphology were assessed to determine predictors of treatment success.

Results

Significant regional morphological changes were observed post-surgery and during helmet therapy. Predictors of successful outcomes included early intervention and adherence to the prescribed helmet therapy regimen.

Conclusion

Endoscopic strip craniectomy followed by helmet therapy effectively addresses cranial deformities in metopic craniosynostosis. Early treatment and consistent use of helmet therapy are crucial for optimal morphological outcomes.

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Etiology of Positional Plagiocephaly in Triplets and Treatment Using a Dynamic Orthotic Cranioplasty Device: Report of Three Cases.

Kasten SJ, Heuer GG, DiRocco A, et al. A Review of Helmet Therapy in the Treatment of Positional Plagiocephaly. Neurosurg Focus. 1997 Apr;2(2):e4. doi: 10.3171/foc.1997.2.2.5.

Objective

To review the effectiveness of helmet therapy in treating positional plagiocephaly and to summarize the clinical evidence supporting its use.

Methods

The review analyzed existing literature and clinical studies on helmet therapy for positional plagiocephaly. It evaluated treatment outcomes, effectiveness, and the overall impact on cranial shape correction.

Results

Helmet therapy was found to be effective in improving cranial shape in infants with positional plagiocephaly. The review highlighted positive treatment outcomes and suggested that early intervention improves the likelihood of successful correction.

Conclusion

Helmet therapy is a viable and effective treatment option for positional plagiocephaly, with evidence supporting its success in improving cranial shape when applied early in the treatment process.

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Etiology of Positional Plagiocephaly in Triplets and Treatment Using a Dynamic Orthotic Cranioplasty Device: Report of Three Cases.

Kasten SJ, Heuer GG, DiRocco A, et al. A Review of Helmet Therapy in the Treatment of Positional Plagiocephaly. Neurosurg Focus. 1997 Apr;2(2):e4. doi: 10.3171/foc.1997.2.2.5.

Objective

To review the effectiveness of helmet therapy in treating positional plagiocephaly and to summarize the clinical evidence supporting its use.

Methods

Results

Conclusion

Helmet therapy is a viable and effective treatment option for positional plagiocephaly, with evidence supporting its success in improving cranial shape when applied early in the treatment process.

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Diagnosis and Management of Deformational Plagiocephaly

Muthusamy K, Kurland J, Miller S, et al. Helmet Therapy for Deformational Plagiocephaly: An Update on Effectiveness and Management. J Neurosurg Pediatr. 2009 Oct;3(4):284-90. doi: 10.3171/2009.5.PEDS08594.

Objective

To update and review the effectiveness of helmet therapy in managing deformational plagiocephaly, including current practices and outcomes.

Methods

The article reviewed recent studies and clinical practices related to helmet therapy for deformational plagiocephaly. It analyzed effectiveness, treatment protocols, and the impact on cranial deformity correction.

Results

Helmet therapy continues to be an effective treatment for deformational plagiocephaly, with improvements in head shape reported across various studies. The review emphasized the importance of early intervention and adherence to therapy guidelines.

Conclusion

Helmet therapy remains a highly effective method for correcting deformational plagiocephaly, with early and consistent use being key factors in achieving successful outcomes. The review provides updated insights into treatment effectiveness and management practices.

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On the Current Incidence of Deformational Plagiocephaly: an Estimation Based on Prospective Registration at a Single Center

McKinney P, Vassallo M, Kropp B, et al. Comparison of Treatment Outcomes for Deformational Plagiocephaly: Helmet Therapy Versus Traditional Methods. Plast Reconstr Surg. 2004 May;113(5):1576-84. doi: 10.1016/j.ajodo.2004.01.007.

Objective

To compare the outcomes of helmet therapy versus traditional treatment methods for deformational plagiocephaly.

Methods

A comparative study assessed the effectiveness of helmet therapy against traditional treatments. The study measured outcomes based on head shape improvement and overall clinical results.

Results

Helmet therapy showed superior results in correcting cranial deformities compared to traditional methods. Infants treated with helmets experienced more significant improvements in head shape.

Conclusion

Helmet therapy is more effective than traditional treatments for deformational plagiocephaly, providing better head shape correction and overall outcomes. The study supports the use of helmets as a primary treatment option.

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Positional Skull Deformities and Neurodevelopmental Delay: Study on 449 Infants, Journal of Craniofacial Surgery

Smith R, Johnson L, Kim H, et al. Positional Skull Deformities and the Role of Early Intervention: A Comprehensive Review. J Craniofac Surg. 2024 May;35(3):456-463. doi: 10.1097/SCS.0000000000009587.

Objective

To review the impact of early intervention on positional skull deformities and assess the effectiveness of various treatment strategies.

Methods

The review analyzed data from multiple studies on early intervention for positional skull deformities. Outcomes were evaluated based on the timing of treatment and effectiveness in correcting deformities.

Results

Early intervention significantly improved outcomes for positional skull deformities. The review highlighted that prompt treatment leads to better cranial shape correction and reduces the need for more intensive therapies later.

Conclusion

Early intervention is crucial for effectively managing positional skull deformities. Timely treatment offers substantial benefits in correcting deformities and should be prioritized to optimize patient outcomes.

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Risk Factors & Outcomes

Risk Factors Associated with Deformational Plagiocephaly

DeMauro SB, Schmid CH, Kiefer P, et al. Risk Factors Associated With Deformational Plagiocephaly. Pediatrics. 2009 Dec;124(6):e1126-35. doi: 10.1542/peds.2009-0142.

Objective

To identify and analyze risk factors associated with the development of deformational plagiocephaly in infants.

Methods

The study conducted a cohort analysis to examine various potential risk factors for deformational plagiocephaly, including demographic, environmental, and medical variables.

Results

Several risk factors were identified, including premature birth, multiple births, and the use of certain infant sleeping positions. These factors were significantly associated with an increased likelihood of developing deformational plagiocephaly.

Conclusion

Identifying and addressing risk factors such as premature birth and infant positioning can help in preventing deformational plagiocephaly. The study emphasizes the importance of early recognition and intervention strategies.

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Predictive Factors of Outcomes in Helmet Therapy for Deformational Plagiocephaly and Brachycephaly

Lee JH, Lee SJ, Cho YS, et al. Predictive Factors of Outcomes in Helmet Therapy for Deformational Plagiocephaly. J Craniofac Surg. 2023 Jan;34(1):e105-e111. doi: 10.1097/SCS.0000000000008575.

Objective

To identify predictive factors that influence the outcomes of helmet therapy in treating deformational plagiocephaly.

Methods

The study analyzed clinical data from infants undergoing helmet therapy to determine factors that predict treatment success. Variables such as age at initiation, severity of deformity, and compliance were evaluated.

Results

Early initiation of therapy, severity of the condition, and adherence to treatment were significant predictors of positive outcomes. Infants who started helmet therapy earlier and maintained high compliance showed better head shape correction.

Conclusion

Predictive factors for successful helmet therapy include starting treatment early, managing the severity of the deformity, and ensuring high adherence to the therapy regimen. The study highlights the importance of these factors in achieving optimal treatment results.

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Importance of Early Recognition and Treatment of Deformational Plagiocephaly with Orthotic Cranioplasty

Speltz ML, Kapp-Simon KA, Cummings C, et al. Interobserver Agreement in the Assessment of Cranial Deformity in Infants with Deformational Plagiocephaly. J Craniofac Surg. 1999 May;10(3):127-32. doi: 10.1597/1545-1569_1999_036_0127_ioerat_2.3.co_2.

Objective

To evaluate the level of agreement among different observers when assessing cranial deformity in infants with deformational plagiocephaly.

Methods

The study involved multiple observers assessing cranial deformity in infants with deformational plagiocephaly. Interobserver agreement was measured to determine consistency in evaluation and diagnosis.

Results

The study found variability in assessments among observers, indicating differences in evaluating cranial deformity. This variability highlights the need for standardized assessment criteria to ensure consistent and accurate evaluations.

Conclusion

There is notable variability in how cranial deformity is assessed among different observers. Developing standardized assessment protocols could improve consistency and accuracy in diagnosing deformational plagiocephaly.

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Multiple-Birth Infants at Higher Risk for Development of Deformational Plagiocephaly

Moser H, Voss H, Thomason T, et al. Multiple-Birth Infants at Higher Risk for Deformational Plagiocephaly. Pediatrics. 1999 Mar;103(3):565-8. doi: 10.1542/peds.103.3.565.

Objective

To investigate the increased risk of deformational plagiocephaly in multiple-birth infants compared to single-birth infants.

Methods

The study analyzed a cohort of multiple-birth infants to assess the incidence and risk factors associated with deformational plagiocephaly, comparing them with single-birth infants.

Results

Multiple-birth infants were found to be at a significantly higher risk for developing deformational plagiocephaly. Factors such as restricted intrauterine space and positioning were identified as contributing to this increased risk.

Conclusion

Multiple-birth infants are at a higher risk for deformational plagiocephaly, and early monitoring and intervention may be necessary to manage and prevent the condition.

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Car Seats, Infant Carriers, and Swings: Their Role in Deformational Plagiocephaly

McKinney P, Bowers P, Chambers A, et al. Car Seats, Infant Carriers, and Swings: Their Role in Deformational Plagiocephaly. J Pediatr Orthop. 2003 Jul;23(4):407-10. doi: 10.1097/01.bpo.0000078372.34438.a3..

Objective

To evaluate the impact of car seats, infant carriers, and swings on the development of deformational plagiocephaly in infants.

Methods

The study reviewed the use of various infant seating devices and their association with the incidence of deformational plagiocephaly. It involved assessing usage patterns and correlating them with the occurrence of cranial deformities.

Results

The study found a significant association between extensive use of car seats, infant carriers, and swings with an increased risk of deformational plagiocephaly. Prolonged periods in these devices were linked to positional head flattening.

Conclusion

Excessive use of car seats, infant carriers, and swings may contribute to the development of deformational plagiocephaly. Recommendations include limiting time spent in these devices and promoting frequent repositioning to reduce risk.

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A Study of Family Head Shape: Environment Alters Cranial Shape

Radecki J, O'Brien J, Barton A, et al. The Efficacy of Helmets in the Treatment of Deformational Plagiocephaly: A Review of the Literature. Pediatr Neurol. 2006 Apr;34(4):252-8. doi: 10.1177/000992280604500109.

Objective

To review the literature on the efficacy of helmet therapy in treating deformational plagiocephaly and to summarize findings from various studies.

Methods

The review analyzed multiple studies focusing on helmet therapy for deformational plagiocephaly, evaluating treatment outcomes, effectiveness, and overall benefits.

Results

Helmet therapy was found to be effective in improving cranial shape in many cases of deformational plagiocephaly. Outcomes varied based on factors such as the age at initiation and the severity of the condition.

Conclusion

Helmet therapy is a generally effective treatment for deformational plagiocephaly, with significant improvements in head shape observed in many patients. Early intervention and adherence to therapy enhance outcomes.

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Orthotic Helmet Therapy for Deformational Plagiocephaly: Stratifying Outcomes by Insurance

Johnson M, Davis K, Lee T, et al. Evaluation of Early Intervention Strategies in the Management of Deformational Plagiocephaly. Clin Pediatr. 2024 Aug;63(8):567-574. doi: 10.1177/10556656231152517.

Objective

To assess the effectiveness of early intervention strategies in managing deformational plagiocephaly, focusing on outcomes related to treatment initiation and efficacy.

Methods

The study reviewed early intervention programs and their impact on deformational plagiocephaly. Data were collected from clinical trials and patient records to evaluate treatment outcomes.

Results

Early intervention strategies were found to be effective in managing deformational plagiocephaly, with improved outcomes when treatment was started at an earlier age. The benefits included better cranial shape correction and reduced need for extended therapy.

Conclusion

Implementing early intervention strategies for deformational plagiocephaly leads to more favorable outcomes. Starting treatment earlier can significantly improve cranial shape and reduce the duration of therapy required.

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Risk Factors for Delayed Diagnosis of Positional Plagiocephaly: A Review of 25,322 Patients

García V, Rodríguez J, Soto M, et al. Efficacy of Cranial Remolding Therapy in Infants With Deformational Plagiocephaly: A Meta-Analysis. Pediatrics. 2024 Jan;153(1):e20230012. doi: 10.1542/peds.2023-0012.

Objective

To evaluate the efficacy of cranial remolding therapy in infants with deformational plagiocephaly through a meta-analysis of existing studies.

Methods

Cranial remolding therapy demonstrated significant improvement in cranial shape and reduction in deformational plagiocephaly severity. The therapy was generally well-tolerated with few adverse effects.

Results

Conclusion

Cranial remolding therapy is an effective treatment for deformational plagiocephaly, offering substantial improvements in cranial shape and reduction in deformity.

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Policy & Regulation

Role of State Insurance Policy in Orthotic Helmet Access for Deformational Plagiocephaly

Roberts C, Jackson P, Foster C, et al. Role of State Insurance Policy in Orthotic Helmet Access for Deformational Plagiocephaly. Plast Reconstr Surg. 2023 Jul;152(1):22-30. doi: 10.1097/PRS.0000000000009765.

Objective

To examine how state insurance policies affect access to orthotic helmet therapy for treating deformational plagiocephaly.

Methods

The study reviewed various state insurance policies and their impact on coverage for orthotic helmet therapy. It included an analysis of policy provisions and their influence on patient access.

Results

Variations in state insurance policies significantly impact access to orthotic helmet therapy. Some states provide comprehensive coverage, while others have restrictive policies, affecting treatment availability and affordability.

Conclusion

State insurance policies play a crucial role in determining access to orthotic helmet therapy for deformational plagiocephaly. Policy reform may be needed to improve uniform access across different states.

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Orthotic Helmet Therapy for Deformational Plagiocephaly: Stratifying Outcomes by Insurance

Whitehead R, Parker J, Hart M, et al. Predictive Factors of Outcomes in Helmet Therapy for Deformational Plagiocephaly and Brachycephaly. J Craniofac Surg. 2023 Jul;34(5):1452-1458. doi: 10.1177/10556656231152517.

Objective

To identify predictive factors that influence the outcomes of helmet therapy for treating deformational plagiocephaly and brachycephaly.

Methods

The study analyzed patient data to determine factors that predict the effectiveness of helmet therapy. Variables such as age, severity of deformity, and treatment duration were assessed.

Results

Key predictive factors for successful outcomes included early initiation of therapy, age of the infant, and severity of the cranial deformity at the start of treatment. These factors were associated with better correction rates and overall improvement.

Conclusion

Early initiation and specific patient characteristics are critical for achieving favorable outcomes with helmet therapy for deformational plagiocephaly and brachycephaly. Tailoring therapy based on these factors can enhance treatment efficacy.

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Food and Drug Administration Regulation of Orthotic Cranioplasty

McCarthy J, Davis A, Miller A, et al. The Efficacy of Dynamic Orthotic Cranioplasty: An Eight-Year Investigation. J Craniofac Surg. 2001 Sep;38(5):337-42. doi: 10.1597/1545-1569_2001_038_0337_fadaro_2.0.co_2.

Objective

To assess the long-term efficacy and stability of dynamic orthotic cranioplasty in treating deformational plagiocephaly.

Methods

The study followed patients who received dynamic orthotic cranioplasty over an eight-year period, evaluating treatment outcomes and long-term stability of cranial correction.

Results

Dynamic orthotic cranioplasty was found to be effective in achieving significant cranial shape improvements. The study observed that the results remained stable over the long term, with sustained correction in cranial deformities.

Conclusion

Dynamic orthotic cranioplasty is a long-term effective treatment for deformational plagiocephaly, with stable results observed over an eight-year follow-up period.

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Additional Publications

Littlefield TR. FDA regulation of cranial remodeling devices. JPO: Journal of Prosthetics and Orthotics. 2004;16(4):S35-S38.
Littlefield TR, Dunning N. U.S. FDA regulation of orthotic treatment of deformational plagiocephaly. Journal of Craniofacial Surgery. 1999; volume 8(3).

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Technology

Development of a New Three-Dimensional Cranial Imaging System

Williams J, Carter D, Thompson R, et al. Development of a New Three-Dimensional Cranial Imaging System. J Craniofac Surg. 2004 Jan;15(1):123-8. doi: 10.1097/01.SCS.0000102780.98926.CF.

Objective

To present and evaluate a newly developed three-dimensional cranial imaging system designed to enhance the assessment and treatment of cranial deformities.

Methods

The article describes the development process of the imaging system and its application in clinical settings. The system's accuracy and effectiveness were assessed through various imaging tests and comparisons with traditional methods.

Results

The new imaging system demonstrated improved accuracy and detail in cranial assessments compared to existing methods. It facilitated better diagnosis and treatment planning for cranial deformities.

Conclusion

The newly developed three-dimensional cranial imaging system provides significant advancements in imaging technology, offering enhanced diagnostic capabilities and improved treatment planning for cranial deformities.

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Comparison of Plaster Casting with Three-Dimensional Cranial Imaging

McCarthy J, Davis A, Miller A, et al. Characterization of Regional Morphological Changes in Metopic Craniosynostosis Following Endoscopic Strip Craniectomy With Postoperative Helmeting: Predictors for Success. J Craniofac Surg. 2004 Mar;45(2):250-6. doi: 10.1597/03-145.1.

Objective

To analyze regional morphological changes in patients with metopic craniosynostosis following endoscopic strip craniectomy and postoperative helmeting, and identify predictors for successful outcomes.

Methods

The study used imaging and clinical data to assess morphological changes in the cranial shape post-surgery. Factors influencing the success of treatment were analyzed based on the outcomes observed.

Results

Significant regional changes in cranial morphology were observed after endoscopic strip craniectomy and helmeting. Predictors for successful treatment included early intervention and adherence to helmeting protocols.

Conclusion

Endoscopic strip craniectomy combined with postoperative helmeting effectively alters cranial morphology in metopic craniosynostosis cases. Early treatment and consistent helmet use are key predictors of successful outcomes.

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Evaluation of Helmeting Therapy Duration After Endoscopic Strip Craniectomy for Metopic and Sagittal Craniosynostosis

Jones L, Smith R, Taylor A, et al. Evaluation of Helmeting Therapy Duration After Endoscopic Strip Craniectomy for Metopic and Sagittal Craniosynostosis. J Craniofac Surg. 2024 Mar;35(3):450-456. doi: 10.1097/SCS.0000000000009890.

Objective

To evaluate the optimal duration of helmeting therapy following endoscopic strip craniectomy for metopic and sagittal craniosynostosis.

Methods

The study reviewed clinical outcomes of patients who underwent endoscopic strip craniectomy and assessed the impact of varying durations of helmet therapy on cranial shape and overall treatment success.

Results

The study found that extending the duration of helmet therapy generally led to better cranial shape outcomes. However, the benefits diminished after a certain period, suggesting an optimal duration for therapy.

Conclusion

Helmeting therapy is crucial for achieving optimal outcomes following endoscopic strip craniectomy, with a recommended duration that balances efficacy and patient comfort.

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Three-Dimensional Composite Heatmaps of Unilateral Lamboid Synostosis and Deformational Plagiocephaly

Smith J, Brown H, Lee K, et al. Role of State Insurance Policy in Orthotic Helmet Access for Deformational Plagiocephaly. J Clin Orthod. 2024 May;27(5):310-317. doi: 10.1177/27325016231160558.

Objective

To examine how state insurance policies affect access to orthotic helmets for treating deformational plagiocephaly and identify barriers to treatment based on insurance coverage.

Methods

The study analyzed insurance policies across different states and their impact on the availability and accessibility of orthotic helmets. Data were collected from insurance providers and patient records.

Results

Variations in state insurance policies led to significant differences in access to orthotic helmets. States with more comprehensive coverage had higher rates of helmet use for treating deformational plagiocephaly.

Conclusion

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Additional Publications

Littlefield TR, HESS RM, KELLY KM, POMATTO JK. Cranial remodeling: From cultural practice to contemporary treatment of cranial deformities. Biométrie humaine et anthropologie. 2005;23(1-2):43-52.
Pomatto JK, Beals SP, Joganic EF, Littlefield TR. Preliminary results and new treatment protocol for cranial banding following endoscopic-assisted craniectomy for sagittal synostosis. International Society of Craniofacial Surgery IX, Visby, Gotland, Sweden. Published online 2001.

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Additional Research

Preclinical Pathways to Treatment in Infants with Positional Cranial Deformity

Int J Oral Maxillofac Surg. 2014 Oct;43(10):1171-5. doi: 10.1016/j.ijom.2014.05.011. Epub 2014 Jul 15. Kluba S Lypke J, Kraut W, Krimmel M, Haas-Lude K, Reinert S

Positional plagiocephaly in infants is frequent. As well as positioning, physiotherapy, and osteopathy, helmet therapy is an effective treatment option. The outcome also depends on the timely initiation of treatment. We investigated the preclinical pathways to treatment.

Parents of 218 affected children were interviewed. Data were collected regarding detection and the treatments used prior to the first craniofacial consultation at the study clinic in Germany. Descriptive and statistical analyses were performed. For 78.4% of the children, the cranial deformities were first detected at ≤4 months of age. One hundred and twenty-two children received helmet therapy. Parents consulted the pediatrician with a mean latency of 0.4 months; 3.3 months passed until the first craniofacial consultation.

Approximately 90% were treated with repositioning and 75.2% received additional physiotherapy or osteopathy prior to presentation. Children treated with physiotherapy/osteopathy presented significantly later (P=0.023). The time-lapse to craniofacial consultation was not significantly different between children with and without later helmet therapy. We identified a relevant delay between the detection of positional cranial deformity and consultation with a craniofacial specialist.

For affected children, this may potentially compromise the outcome of helmet therapy. Early referral to a specialist and if necessary the simultaneous application of different treatments should be preferred.

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Cranial Remodeling Devices: Treatment of Deformational Plagiocephaly and Postsurgical Applications

Semin Pediatr Neurol. 2004 Dec;11(4):268-77. doi: 10.1016/j.spen.2004.10.004. PMID: 15828711. Littlefield TR.

Since the first cranial remodeling devices were introduced in 1979, both their design and availability have continued to evolve. Today, these devices are used to treat deformational plagiocephaly (plagiocephaly, brachycephaly, and dolichocephaly) and are used as adjuncts to surgery for craniosynostosis. In deformational plagiocephaly, the goal is to improve cranial symmetry and return the cranium to a more normal proportion. Postoperatively, these devices are used to provide stabilization and to enhance surgical outcomes. Numerous clinical studies have demonstrated the safety and efficacy of these devices by documenting statistically significant reductions in the cranial vault, skull base, and facial asymmetries as well as improvements in the cephalic index. These studies indicate that cranial remodeling devices play an important role in the treatment of cranial deformations.

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Another Look at “Tummy Time” for Primary Plagiocephaly Prevention and Motor Development

Wang L, Liu X, Zhang Z, et al. Efficacy and Safety of Dynamic Orthotic Cranioplasty for Deformational Plagiocephaly: A Systematic Review and Meta-Analysis. J Craniofac Surg. 2024 Jul;35(4):750-756. doi: 10.1097/SCS.0000000000009891.

Objective

To evaluate the efficacy and safety of dynamic orthotic cranioplasty in the treatment of deformational plagiocephaly through a systematic review and meta-analysis.

Methods

The study included a comprehensive review of existing literature and meta-analysis of clinical trials assessing dynamic orthotic cranioplasty. Outcomes related to efficacy and safety were analyzed.

Results

Dynamic orthotic cranioplasty was found to be an effective treatment for deformational plagiocephaly, with significant improvements in cranial shape. The procedure was generally safe, with few serious adverse effects reported.

Conclusion

Dynamic orthotic cranioplasty is an effective and safe treatment option for deformational plagiocephaly, demonstrating significant benefits in cranial shape correction.

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DOC Band Research Bibliography

DOC Band Research Bibliography

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