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Dear Parents, Physicians and other Providers:


A recent study in the British Medical Journal which was reported in The New York Times, concluded that helmet therapy “had virtually no treatment effect" in the correction of plagiocephaly.  Entitled “Helmet therapy in infants with positional skull deformation: randomized control trial" and published originally in the Netherlands, the article has generated media attention that raises efficacy concerns among parents and health care providers. 
 

Following the article's publication, a number of experts noted that the scientific methods used in the Dutch report were inherently flawed in several important ways that called into question the validity of  the results.  For the official response by the American Orthotics and Prosthetics Association, click here

The limitations of the Dutch study included the following:  First, the subject pool included patients with only mild to moderate plagiocephaly, thereby excluding severe cases.  Second, the researchers reported helmet fitting problems with 73%  of the subject population.  Without controlling for optimal fit, poor outcomes are naturally to be expected.  Figure 1 shows an example of a poorly fitting helmet from the Dutch study.  Compare the asymmetrical shape, the looseness of the fit, and the gaps between head and helmet with the Ballert Helmet pictured in Figure 2.  Finally, the study did not control for clinical protocols and manufacturing practices  that relate to quality of fit and clinician management skills.

   
Figure 1.  Example of poorly fitting 
helmet from Dutch study
 

Figure 2. Ballert Molding Helmet

 

In contrast, a number of studies over the past several years have shown cranial molding helmets, properly fitted, to be an effective treatment for plagiocephaly (see references below).  We at Ballert Orthopedic have confirmed these results through our own internal study. 
 

Like all such studies, Ballert assesses the success of cranial molding helmet treatment by comparing cranial measurements  taken before and after treatment.  The most recent of our studies examined results for 83 patients seen within the past year by one of our practitioners.  The subjects were all infants with plagiocephaly ranging from mild to moderate to severe.  On average, the heads of these babies deviated 7.3 mm from normal before treatment.  After being carefully fitted with a Ballert Molding Helmet, and followed over the next several months with appropriate adjustments by a certified orthotic practitioner, the crania of these babies corrected to 2.67 mm divergence from normal.  The magnitude of the average correction is well within statistical significance.   (See Table 1 below).

Table 1


Ballert Orthopedic continues to achieve a significant correction rate through its rigorous attention to evaluation, measurement and fabrication protocols of its cranial molding helmets.   Further attention is given to assuring continuity of fit and follow up to ensure optimal correction. 
 

These results emphasize Ballert’s successful application of the cranial molding helmet and reinforce the legitimacy of the use of helmets in the standard routine of care in the treatment of plagiocephaly.  Ballert is committed to the highest level of clinical care for its babies and families and will continue to educate and provide expert professional service in this practice.
 

 

Gene P. Bernardoni, C.O.
President


Stephen Kim, CO.
 

References 

Fish, D., and Lima, D.  An Overview of Positional Plagiocephaly and Cranial Remolding Orthosis.  JPO, Vol. 15, No. 2 (2003), p. 37.
 

Grigsby, K. Cranial Remolding Helmet Treatment of Plagiocephaly:  Comparison of Results and Treatment Length of Younger versus Older Infant Populations.  JPO, Vol. 27, No. 1 (2009), p. 55.
 

Kelley, K., Littlefield, T., and Joganic, E. F. Importance of Early Recognition and Treatment of Deformational Plagiocephaly with Orthotic Cranioplasty.  Cleft Palate Craniofac J. Mar:36(2) (1999), p. 127-130.
 

Robison, S., and Proctor, M.  Diagnosis and Management of Deformational Plagiocephaly: A Review.  J. Neurosurg. Pediatrics 3 (2009, pp. 284-295.
 

Yoo, H.-S. and Rah, D.K..  Outcome Analysis of Cranial Molding Therapy in Non-Synostotic Plagiocephaly.  Archives of Plastic Surgery, Vol. 39, No. 4 (July 2012), pp. 334-344.