Helmet Companies, and the Business of Selling Helmets.
Notwithstanding the anti-helmet rhetoric and methodologically-flawed papers that suggest helmet therapy is useless, I still think think there is a role for helmet therapy in infants with moderate to severe cranial asymmetry. Sure, moderate degrees of asymmetry typically improve with time and growth, but it can take many years for the flat spot to “grow out”. The popular notion that all cranial flattening resolves over time is simply not accurate. I would encourage anyone who doubts that cranial flattening can and does persist in patients to read my papers and look at the examples I have posted in the web text. And these patient examples are not unique. Hutchinson et al (Arch Dis Child, 2011) found that at 3-4 year follow-up, only 61% of patient with plagiocephaly as infants had “normal” shapes and 4% were still severely affected. Similar result have been reported in other studies. A thoughtful survey of adult head shapes on a crowded public street reveals many individuals with persistent brachycephaly (pan-occipital flattening). This is especially true in parts of the world with long-standing traditions of back sleeping and/or swaddling. Various degrees of plagiocephaly, or asymmetric flattening, are also present in adults (see below image) but the discrepancy usually stops worsening after 4-5 months of age and as the head continues to grow, the asymmetry becomes less visible on the larger head. Moreover, a significant occipital asymmetry that is easy to see in an infant or young child when viewed from the top of the head, is much harder to detect when the child grows up and the head is viewed from the posterior (back) perspective. The net effect of this change in visual perspective can be understood with a simple analogy. Anyone who has been to New York has marveled at the height of the Empire State Building. It is not necessary to measure the height as the enormity is easily extrapolated by comparing it to adjacent buildings, which are also large when viewed from the street. But what if we viewed the buildings in the area from above their rooftops, say in a helicopter? Would we still be able to discern how tall the Empire State Building is relative to the adjacent buildings? Probably not. Thus, the perspective from which an asymmetry is viewed is paramount. This is all to say that we would expect cranial asymmetry to look better with time through the effects of growth (relative improvement) and change in visual perspective. It should be noted that the ameliorating effects of growth and perspective are most dramatic for plagiocephaly and less so for brachycephaly. That is why pan-occipital flattening is quite prevalent in the adult population (especially in countries with long-standing cultural traditions of back sleeping their infants), while cranial asymmetry is not.
This leads back to the topic of helmets and their utility. I do believe that for patients with significant asymmetry or pan-occipital flattening benefit from helmet therapy. Helmets that are properly made and contoured, worn consistently, and are implemented at an age conducive to correction (preferably <12 months, but can still work up to 18 months) can have a significant positive effect on head shape. While one could argue, as I did above, that the shape will EVENTUALLY improve with growth, why should parents have to sit and observe an acquired deformity year after year until it improves? For many parents, visible head flattening is a source of anxiety and concern. How then can some clinicians justify summarily dismissing their concerns? Of course, it is wasteful to indiscriminately prescribe helmets for every shape difference. In fact, minor shape differences are part of normal human variability. Nevertheless, when an infants cranial shape difference is greater than certain measures (i.e., cephalic index > 0.9 and/or transcranial difference of >= 10 mm), it should be a parents right to restore their child’s head shape to that of other infants. There is no question that helmet therapy is the most rapid and definitive method for correcting established flattening.
With that said, I have a real issue with the “salesmanship” of some helmet manufacturing companies. As a front-line clinician with a vast experience managing patients with cranial flattening, I have heard all the high pressure gibberish spewed by some helmet companies. “If you don’t fix this, your child will have developmental delays, ear infections, problems with their jaw and dental alignment, and so on. Suffice it to say that these scare tactics are just that. There is no credible evidence that deformational flattening CAUSES any of these issues. Yes, there is an association between cranial flattening and developmental delay because developmental delay leads to poor muscle tone, reduced independent head mobility and, as a result, flattening. No one in the scientific community believed that flattening actually CAUSES developmental delay. If that were true, we would have seen a major drop in IQ and development scores after the 1993 Back to Sleep Campaign was instituted. Even though that initiative saw a massive rise in the percentage of kids with head flattening (up to 20% in some studies), there was no corresponding change in childhood development or IQ scored. All risk factors for deformational flattening (torticollis, developmental delay, prematurity, iatrogenic constraint) lead to flattening because they result in decreased head mobility in the first months of life. I would encourage any parent dealing with these concerns to read the relevant sections in the text of my web page. Cranial flattening occurs in only 15-20% of infants who sleep on their back and the unifying risk factor for those affected is decreased head mobility. Infants with normal motor tone and no muscular or iatrogenic restriction of head motion are simply not at risk for flattening.
This tenet is critical for predicting which infants are at risk for getting flat and which are not. While I have seen this play out hundreds of times with my patients, a personal example may be more illustrative. I have four children and none of them were affected by head flattening. What is most interesting is that my wife and I took no additional steps to prevent flattening. While I had already developed the PerfectNoggin Infant Mattess by the time by second child was born, I was not concerned that any of my kids would become flat. How could I be so sure? Because none of my children had any of the underlying risk factors for flattening. My kids were all full term, had no head position preference and excellent head range of motion to both sides (i.e., not torticollis or cervical imbalance), and had normal motor tone. Contrast my experience to that of my two brothers. My two nieces and one nephew were also born at term, but each of them had a clear “preferred” head position in the first few weeks. I recall asking both of my brothers if their newborn could turn their head to the other side or hold an alternative head position for an extended period of time. They could not. My brothers, in classic Rogers fashion, discounted my advice for prevention (I offered to send the PerfectNoggin to them for free!). Three month later, they were calling about head flattening! Recognizing a head position “preference” is the most important factor in determining whether your child will develop head flattening or not.
One last comment about helmeting and the choice of helmet company. There are many orthotists and centers from which to choose. In my experience, I would recommend a center that has significant experience with the manufacturing and fitting of cranial orthoses. Many mom-and-pop shops make helmets (since it can be a cash cow for a busy shop) but I find the work, and the outcomes, far too variable to recommend. I do not endorse any particular helmet company, but there are some business practices that should put you on your guard. Remember, helmet therapy is big business and I have witnessed far too many examples of dishonest and unethical business practices. I would avoid any helmet shop that:
1. Suggests your child will have medical problems or consequences if you do not correct the flattening. This is a RED FLAG to run away. These are scare tactics that have little or no basis in medical science.
2. Takes referrals directly by a physical therapist or other allied health professional without first involving your pediatrician. Because torticollis is the largest etiologic risk factor for cranial flattening, physical therapist are often consulted early in treatment. I am a bit skeptical about this practice as most patients will resolve torticollis without any particular intervention, but this is the dogma. I, and my colleagues, have seen a large rise in patients who are sent to helmet companies directly by a PT, OT, or other allied health professional. That is because some helmet companies staff their centers with clinicians (NP or MD) who can independently evaluate and prescribe helmets and do not need a prescription or referral from the pediatrician or specialist. This allows patients to bypass the pediatrician’s valuable input. It is unclear if there is a financial relationship between these referring PT or OT groups and the involved helmet companies, but this practice creates a major conflict of interest because the person determining the need for helmet therapy is employed by the company that makes the helmet. I see a good number of patients for a second opinion because they were referred to a helmet company in this manner and were confused, bewildered, and justifiably suspicious of the entire process. It is familiar story- the infant is diagnosed with torticollis, gets a PT referral, and the PT sends the child to a helmet shop for a head shape evaluation. The parents, who thought the baby’s head shape was fine, are then told by the clinical staff of the helmet shops that the head shape is really bad and must be corrected or it will lead to a slew of functional problems. Of course, for those infant’s whose head shape is moderate to severely affected, a helmet is probably a reasonable recommendation. Unfortunately, we see a large number of patients with normal or near normal-looking head shapes that had the same recommendation- a helmet is needed. I am sure there is a large group of parents in this cohort who put their trust the verdict of the “experts” and follow the recommendation for helmet therapy. But remember, these “experts” are paid by the orthotic company to sell helmets, not turn away patients. When patient come see me for a second opinion in these situations, they come loaded with a nice glossy marketing packet and a clinical evaluation that, in my opinion, frames the problem in a way that seems to support helmet use in virtually every child! For example, some companies deem a cephalic index of >0.85 to reflect moderate brachycephaly, and an asymmetry of >6 mm to define moderate plagiocephaly. These difference are nominal and most unbiased clinicians would place these measurements squarely in the normal spectrum of cranial shapes, consistent with the published literature (see below links). Moreover, the presence of a greater than normal cranial measurement DOES NOT de facto imply that treatment is needed or recommended. I and many other authors do not consider the above measurements significant enough to consider helmet treatment, especially given the mitigating effects of growth on CI (tends to drop 3% over first 2 years) and OCR (drop after 4 months). For more information on normal head shapes and changes with growth see:
3. Requires more than one helmet to correct the deformity. In general, one helmet is sufficient to correct all but the very worst head shape differences. My preference is for helmets with a thicker foam liner as this design allows for adjustments in shape and size (growth) without requiring the use of a new helmet. Some helmet companies use clear plastic shells that are less adaptable and usually require more than one helmet to complete treatment. This helmet design offers no clear benefit in treatment (can see the head?) but clearly adds to the revenue stream of the helmet manufacturer!
