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Guest Post: Cranial Remolding Helmets Do Not Work…Or do they? A dive into a flawed helmet study.

Written By Andrew Allen

Google “skull deformity helmets” and nearly half of the   results on the first page are articles that criticize helmet therapy for infants, claiming that the expensive orthotics are a total waste of money. Despite numerous studies that support the effectiveness of helmet therapy in correcting plagiocephaly and brachycephaly [3-6], media sources such as The New York Times andBoston.com have released articles that discourage treatment [8,9]. The basis for nearly all of helmet therapy criticism arises from a single study published on May 1, 2014, by Renske van Wijk and a team of researchers in the Netherlands [11]. The study, Helmet therapy in infants with positional skull deformation: randomised controlled trial, compared the 24-month outcomes of infants (aged 5 to 6 months) assigned to either a helmet therapy group or a control group that received no treatment. According to the study, helmet therapy was just as effective in correcting skull deformation as no treatment. Thus, van Wijk et al. discourage the use of helmets when treating moderate cases of skull deformation. There are numerous caveats associated with these conclusions, however, that should be taken into account before deciding to leave your infant’s skull deformity untreated.

Firstly, here is some background information on the condition in the United States. In 1992, the initiation of the “Back to Sleep” campaign resulted in increased numbers of infants sleeping in a supine position to reduce the risk of Sudden Infant Death Syndrome (SIDS). While the campaign has been extremely effective in reducing instances of SIDS, static supine position is one of the leading risk factors for plagiocephaly. Thus, the increase in skull deformity cases since the 1990s is likely correlated with the 1992 campaign [1]. In 2013, plagiocephaly was estimated to affect 46.6% of infants aged 7 -12 weeks [7]. In addition to prolonged external force resulting from static supine position, other risk factors include torticollis (asymmetric tight neck muscles), prenatal uterine constraint, and perinatal birth injury [1]. The two most common treatments are cranial helmets and repositioning practices—a more conservative approach where infants are positioned in prone for short periods of time. According to the van Wijk study, however, natural course is just as effective as the more aggressive, cranial helmet treatment.   

Following publication on May 1, 2014, there was a high volume of critical responses from members of the medical community regarding the study’s results and conclusions. One of the most common criticisms is that the study did not include infants with severe deformities, torticollis, or other developmental neuromuscular issues. Thus, it is still widely believed that infants with severe skull deformities or neuromuscular problems stand to benefit from cranial helmets. Jordan Steinberg, a pediatric plastic surgeon, points out the high percentages of study participants that experienced problems with the cranial helmet during its use in the study [10]. Reportedly, 96% of the infants experienced skin irritation, 76% unpleasant odor, and 33% felt some sort of pain from the helmet. Furthermore, 73% of participants reported improper fit and shifting of the orthotic [11]. Noting these issues, and the low percentages of full recovery in both subject groups, Steinberg concludes that the participants received “inadequate treatment” [10]. Kevin Kelly, a research consultant at Cranial Technologies also comments on these statistics stating, “The lack of improvement seen in their study was the direct result of their ill-fitting helmets” [2]. Had participants received properly fitting helmets and proper care, van Wijk et al. may have observed significantly different outcomes.

Although many view skull deformity as solely a cosmetic issue, “untreated cranial asymmetries have been linked to visual defects, ear infections, middle ear malfunction, jaw bone changes, developmental delay, learning difficulties, and other psychomotor delays” [12]. Treating instances of plagiocephaly and brachycephaly in a timely manner is important for ensuring proper development. The results of van Wijk’s study are not completely reliable and do not annul the value of cranial helmets. The study did not include severe cases of skull deformity, and patients were not properly fitted with their orthotics. More research is certainly necessary to properly characterize the effectiveness of cranial helmets. For the time being, seeing as skull deformities can lead to numerous developmental complications, it should be of primary concern to treat the condition rather than quickly dismissing a device that has been historically successful in correcting countless cases of skull deformity.

1. Grigsby, Katrina. “Cranial Remolding Helmet Treatment of Plagiocephaly: Comparison of Results and Treatment Length in Younger Versus Older Infant Populations.” JPO Journal of Prosthetics and Orthotics 21.1 (2009): 55-63. American Academy of Orthotists and Prosthetists. Web. 1 July 2015. <http://www.oandp.org/jpo/library/2009_01_055.asp&gt;.

2. Kelly, Kevin M. “Re: Helmet Therapy in Infants with Positional Skull Deformation: Randomised Controlled Trial.” Letter to RM Van Wijk. 10 May 2014. The British Medical Journal. BMJ Publishing Group Ltd, n.d. Web. 01 July 2015. <http://www.bmj.com/content/348/bmj.g2741/rapid-responses&gt;.

3. Kim, Se Yon, Moon-Sung Park, Jeong-In Yang, and Shin-Young Yim. “Comparison of Helmet Therapy and Counter Positioning for Deformational Plagiocephaly.” Ann Rehabil Med Annals of Rehabilitation Medicine 37.6 (2013): 785-95. PubMed. Ann Rehabil Med. Web. 26 June 2015. <http://vb3lk7eb4t.search.serialssolutions.com/?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&rfr_id=info:sid/summon.serialssolutions.com&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Comparison of Helmet Therapy and Counter>.

4. Kluba, Susanne, Wiebke Kraut, Benjamin Calgeer, Siegmar Reinert, and Michael Krimmel. “Treatment of Positional Plagiocephaly – Helmet or No Helmet?” Journal of Cranio-Maxillofacial Surgery 42.5 (2013): 683-88. Science Direct. Web. 26 June 2015. <http://vb3lk7eb4t.search.serialssolutions.com/?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&rfr_id=info:sid/summon.serialssolutions.com&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Treatment of positional plagiocephaly – H>.

5. Lee, Robert P., John F. Teichgraeber, James E. Baumgartner, Amy L. Waller, Jeryl D. English, Robert E. Lasky, Charles C. Miller, Jaime Gateno, and James J. Xia. “Long-Term Treatment Effectiveness of Molding Helmet Therapy in the Correction of Posterior Deformational Plagiocephaly: A Five-Year Follow-Up.” The Cleft Palate-Craniofacial Journal 45.3 (2008): 240-45. ProQuest. Allen Press Publishing Services. Web. 26 June 2015. <http://search.proquest.com.libproxy.lib.unc.edu/docview/204925188?pq-origsite=summon&gt;.

6. Lipira, A. B., S. Gordon, T. A. Darvann, N. V. Hermann, A. E. Van Pelt, S. D. Naidoo, D. Govier, and A. A. Kane. “Helmet Versus Active Repositioning for Plagiocephaly: A Three-Dimensional Analysis.” Pediatrics 126.4 (2010): 936-45. Pediactrics. American Academy of Pediatrics. Web. 26 June 2015. <http://pediatrics.aappublications.org.libproxy.lib.unc.edu/content/126/4/e936&gt;.

7. Mawji, A., A. R. Vollman, J. Hatfield, D. A. Mcneil, and R. Sauve. “The Incidence of Positional Plagiocephaly: A Cohort Study.” Pediatrics 132.2 (2013): 298-304. Pediactrics. American Academy of Pediatrics. Web. 1 July 2015. <http://pediatrics.aappublications.org/content/132/2/298&gt;.

8. Saint Louis, Catherine. “Helmets Do Little to Help Moderate Infant Skull Flattening, Study Finds.” The New York Times. 1 May 2014. Web. 26 June 2015

9. Salahi, Lara. “Study: Corrective Baby Helmets Don’t Work.” Boston.com. Boston Globe Media Partners, 1 May 2014. Web. 26 June 2015.

10. Steinberg, Jordan P. “Re: Helmet Therapy in Infants with Positional Skull Deformation: Randomised Controlled Trial.” Letter to RM Van Wijk. 01 Nov. 2014. The British Medical Journal. BMJ Publishing Group Ltd, n.d. Web. 01 July 2015. <http://www.bmj.com/content/348/bmj.g2741/rapid-responses&gt;.

11. Van Wijk, R. M., L. A. Van Vlimmeren, C. G. M. Groothuis-Oudshoorn, C. P. B. Van Der Ploeg, M. J. Ijzerman, and M. M. Boere-Boonekamp. “Helmet Therapy in Infants with Positional Skull Deformation: Randomised Controlled Trial.” BMJ (2014): 348. Thebmj. BMJ Publishing Group Ltd. Web. 26 June 2015. <http://www.bmj.com/content/348/bmj.g2741&gt;.

12. Wang, Judy. “Babies, Misshapen Heads, and Plagiocephaly Helmets: A Physical Therapist Perspective.” Web log post. North Shore Pediatric Therapy. N.p., 20 May 2014. Web. 8 July 2015. <http://nspt4kids.com/parenting/babies-misshapen-heads-plagiocephaly-helmets-physical-therapist-perspective/&gt;.

Guest Post: Review of “Dynamic Response AFO” from Biomechanical Composites (Phatbraces) by John T. Brinkmann, CPO, LPO, FAAOP

Thank you John for your thoughtful review. I look forward to trying one of these.

Over the past two months I’ve delivered two “Dynamic Response AFOs”, designed and fabricated by Biomechanical Composites. The two patients I recently fit with the Dynamic Response AFOs both had very typical presentations. One was an incomplete SCI (secondary to a rare form of spinal fluid cancer) and the other was several years s/p CVA with hemi-paresis. In both cases they presented with a polypro AFO, designed and fabricated according to acceptable orthotic principles. Both patients wore their orthosis out of necessity, but reported significant frustrations with poor function, general discomfort, and associated joint pain.

Both patients reported immediate benefits from the Dynamic Response design. The Dynamic Response AFOs fit very well, with only minimal adjusting required. The flexible, total contact foot design was less bulky and provided improved comfort and control compared to their previous orthoses. But in both cases the greatest benefits were related to the features inherent in the composite materials. I’m still thinking through these cases, and I’ll be following up on each patient, but here are my initial thoughts on the improvements that I observed. The SCI patient had weak quads, and forcibly extended his knee in order to control knee flexion during loading response while wearing the previous orthosis. The hemi-paretic patient hyper-extended his knee in order to achieve knee stability, which caused debilitating pain over time. The dynamic responsiveness allowed by the posterior carbon fiber strut in the new AFOs absorbed the plantarflexion/knee flexion moment at heel strike, essentially providing a stance flexion feature. This allowed a more normal transition to weight acceptance, foot flat, and mid-stance, requiring less control by the patient. The post-CVA patient came in to my office exhibiting toe initial contact while wearing his old orthosis, and achieved heel initial contact and a more normal progression through the rockers of the foot in his first steps while wearing the Dynamic Response AFO.

I’m fairly skeptical of device hype, and I’d like to see some objective gait analysis comparisons on both of these patients. However, my clinical assessment and patient reports in both of these cases revealed a dramatic improvement in almost every way over their previous AFOs. Both patients were thrilled with the new brace, reporting immediate improvements in comfort and function. The SCI patient’s physical therapist reported improvements in his 6 minute walking test, and his daughter told me last week that they are able walk longer distances when shopping. (Functionally a positive outcome, a potential negative economically.) Like most orthotists, I have to make clinical decisions without the advantages of a formal gait lab assessment, and I’ll take these kind of results all day long. This is a great design, and a very well-made product.

Review: SureStep SMO’s for pediatric low tone pronators (note for Parents at end of post)

When I first heard about the SureStep SMO’s I was curious about how they worked. I asked myself, “How can a flexible plastic, with the toes free, taken by measurements SMO fit and be more functional than what I can currently provide for patients?” There was only one way to find out and that was by trying them out. I now have fit upwards of 30 patients with the SureSteps and I am convinced that they work and work well. The patient outcomes I have seen have been amazing. I have seen children instantly go from being unsure on their feet and barely pulling to stand to being able to cruise and take steps in a matter of days.

Measuring for the SureSteps is a breeze and not scary for the children. Fitting is a simple process and the outcomes are sometimes inexplicable. I never ceased to be amazed of how many times I hear, “…how can a little piece of plastic do that.” One of main reasons I like the SureStep is that it relies on hydrostatic loading and compression to get the correction at the calcaneus and through the medial arch. When there is compression over a larger surface area the potential for skin breakdown is minimal. If you have a low tone pronator you may want to give this a shot.

Note For Parents of children with Down’s Syndrome: The SureStep SMO is a great way for your children to gain stability while walking and address concerns about flat feet.

Before:

After:

Review of the Texas Turbo AFO design from Kevin Matthews, CO

Kevin Matthews, CO of Advanced Orthopedic Designs, posted a “how-to” video a while back on YouTube.  After seeing the video, I wanted to try it but never did until now.  The Texas Turbo AFO is a posterior entry AFO that is easy to put on and low profile  due to Kevin’s fabrication ingenuity.  I must admit that the fabrication was not easy, but we did get a perfect pull on the second try.

For my patient, the brace was perfect; he had drop foot and no plantarflexors.  The brace lifted his toes and the anterior aspect of the brace allowed him to push over the toes, essentially getting “fake” plantarflexion.  After seeing the results of this AFO, I believe the design is underutilized in the field of orthotics.  When you are thinking about using a solid ankle AFO to give ankle stability as well as dynamic plantarflexion, you may want to consider this brace.  With the advent of some newer materials, I believe that creating a dynamic AFO with energy return will really take our field to the next level.

Fabrication video from Advanced Orthopedic Designs