Frequently Asked Questions for Parents & Caregivers
What is deformational plagiocephaly?
 Deformational
plagiocephaly is a condition in which a baby's head has an uneven or
irregular shape, typically a flat head.
Craniosynostosis can cause plagiocephaly by the premature fusion of the skull's
sutures, causing an abnormal shape through growth in one direction and
growth at the suture closure. Nonsynostotic plagiocephaly does not require surgery and can usually be treated with a
cranial orthosis (a custom-made brace or helmet for the skull).
Mild positional plagiocephaly may correct itself within the first six weeks of life; if
not, treatment may be appropriate when properly diagnosed.
Who experiences positional plagiocephaly?
Positional plagiocephaly used to occur in one of every 300 babies, including
synostotic and non-synostotic cases. Recent figures for non-synostotic cases are up to 40% of healthy
babies. The increase in the incidence or diagnosis of non-synostotic plagiocephaly has been
attributed to two reasons:
- Increased incidence of multiple births
- The "Back to Sleep" campaign by the American Academy of Pediatrics
in 1994 to place infants on their backs while sleeping to decrease
incidence of Sudden Infant Death Syndrome (SIDS).
What causes non-synostotic positional plagiocephaly?
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Non-synostotic plagiocephaly can occur prior to birth as a result of pressure inside the mother's uterus, usually caused by one of the following:
- The baby dropped early into the mother's pelvis before delivery.
- Bicornase uterus
- The baby was breech
- There were twins or multiples
- The baby was unusually large
- The mother has decreased amniotic fluid or a small pelvis
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After birth, it can also be caused by the baby's frequently lying in the same position,
such as in a crib or car seat.
What are the current treatments?
The primary treatment for positional plagiocephaly is the cranial orthosis. An infant can begin wearing an orthosis between the ages of four to eight months. The orthosis gently reshapes the head as it continues to grow.
Does my insurance pay for cranial remolding orthoses / headbands / helmets?
Each insurance company has different coverage and medical policy guidelines. It is best to contact your insurance company and employer
benefits coordinator to determine the type and level of coverage for
durable medical equipment (DME) and orthotics and prosthetics (O&P). It is not uncommon for insurance companies to require a letter of
medical necessity from your referring physician stating that the Ballert
cranial molding helmet (a cranial remolding orthosis) is medically
necessary and is not being prescribed for cosmetic reasons.
If untreated, problems that may be associated with positional
plagiocephaly include vision and hearing problems, temporomandibular
joint disorder (TMJ), etc. Ask your orthotist and referring physician to provide you with the necessary
information (e.g., prescription, letter of medical necessity, photos) to
assist you in obtaining coverage and reimbursement. Additional information can be found at www.plagiocephaly.org/
(see also Related Sites). Additionally, many insurers publish detailed criteria for durable
medical equipment (DME) on their websites.
Are all cranial molding helmets and bands alike?
The general concept and products are similar, although we feel that it is extremely important to get complete coverage of the cranium to promote the best outcome. We are usually only concerned about the upper cranial vault, and bands really only address that aspect. Your baby has sutures over and around the ears and over the top of the head. Since the helmet works by inhibiting growth in the direction of the buldge while allowing growth in the direction of the flattening, a band which does not give good coverage in the area of the sutures around and above the ears could allow growth or bulging in that area, thereby creating a deformation. It is own experience that only a complete helmet will insure against this albeit relatively uncommon side effect. It is nevertheless a possibility that the Ballert Helmet guards against. Where the window of opportunity can be numbered in a few short months, we feel that it is necessary to ensure the best results possible.
How quickly will my child receive the Ballert Helmet after casting?
Ideally, your child will be wearing his/her helmet within 5 to 7 days of the casting date to
assure proper fit and function. However, insurance approval is typically required before an orthotist can order a
cranial remolding orthosis. If the insurance verification process begins after the casting, this will
delay the turn-around time. Completing the insurance approval process before casting will expedite the time it
takes to get your child in a helmet.
What special training do certified orthotist have that prepares them for taking care of children with positional plagiocephaly?
A certified orthotist is an allied health professional who is specifically trained
and educated to provide or manage the provision of custom-designed,
fabricated, modified and fitted external orthosis (braces) to orthotic
patients. The selection of the orthosis is based on clinical assessment
and the physician’s prescription, in order to restore physiological
function and/or cosmesis. The strong background in patient care using medical biomechanical principles
and materials gives these professionals the skills to manage infants
with positional plagiocephaly. Orthotists have been fitting braces including cranial helmets for over 100 years in
the United States.
Certified orthotists go through extensive training to learn how to evaluate, cast,
fabricate and fit orthosis (braces). There are only a handful of universities in the United States
that have programs for the field of orthotics and these programs must
meet stringent criteria set by the American Board for Certification. Once an orthotist finishes the formal educational portion of
training, he or she begins a residency program under the supervision of
a certified practitioner to gain practical experience. A year’s experience and references are required before the
resident can submit an application to take both a written and a
practical examination. When a resident passes the exam he can use the credentials of C.O. (certified
orthotist)
How long have cranial orthosis been used to treat children with positional plagiocephaly?
Orthotists have treated children with positional plagiocephaly since the 1970s, but have been casting and fitting helmets for much longer. The first article on the use of cranial orthosis to treat positional plagiocephaly was written by Drs. Clarren, Smith, and Hanson in 1979 in a study done at the University of Washington. Two orthotists there, Alan Dralle and David Noss, designed and fabricated the helmets used for the study. Today there are several remolding helmet designs on the market and several specific protocols for treatment.
Why did a lot of orthotists stop making cranial remolding orthosis in the
last few years?
In 1998 the FDA ruled that cranial remolding orthosis fell into the category of Class 2 medical devices and required strict control standards. In order to continue providing these orthosis, centers had to apply for and receive FDA 510(k) clearance, which is an expensive and labor intensive process. Many orthotists stopped providing orthosis at that point because their cranial remolding orthosis design had not gone through the process of being cleared by the FDA.
Has the Ballert helmet been cleared by the FDA (Food and Drug
Administration)?
Yes. Ballert Orthopedic received its clearance to market and manufacture the Ballert Cranial Molding Helmet in June of 2001.
How long does it take the Ballert Helmet to work?
This varies but some parents have seen improvement after only two weeks of the Ballert Helmet. Correction continues over time, and requires complete compliance to achieve the greatest degree of symmetry.
Will my infant experience any discomfort wearing the Ballert Helmet?
In most cases, children adapt quite easily to the orthosis. With younger children and infants, it even becomes something like a security blanket. As your infant begins to wear the orthosis, any concerns you may have can be addressed by your orthotist.
How do I keep the Ballert Helmet clean?
In some cases, a mild unpleasant scalp odor may develop. It is easily controlled with daily washing of the head and the
Ballert Helmet with alcohol. You may also remove the Ballert Helmet for a couple of minutes during the
day to towel or blow-dry your infant's head and helmet. The Ballert Helmet may also have a mild yet harmless chemical
smell that dissipates in a day or two.
Do we need follow up?
Yes. In most cases, your child will need adjustments to the Ballert
Helmet by the orthotist. Contact your orthotist sooner if the Ballert Helmet seems
tight or you notice any problems. The referring physician may wish to see the child after several weeks of
treatment to evaluate progress. We like to check the fit weekly for the first few weeks.
Who tells us when to stop wearing it?
The decision to discontinue wearing the Ballert Helmet should be made by the physician
in conjunction with the orthotist. The orthosis has done its job when the head rounds into the
symmetrical shape of the Ballert Helmet or when the head shape has changed to an acceptable degree of symmetry and has outgrown the Ballert
Helmet.
Will we need more than one Ballert Helmet for treatment?
Generally, the Ballert Helmet is made with multiple removable foam layers to allow for
growth. Very often a single helmet is all that is needed throughout the course of treatment. In cases of severe positional plagiocephaly, it is possible to outgrow the Ballert Helmet before all possible correction may be achieved. If this happens, the physician, orthotist and parents play an active role in determining if another orthosis is appropriate. Any additional orthosis will require new insurance billing and prior approval is recommended before proceeding.
Will the head revert back to the flat shape if the Ballert Helmet is discontinued?
It is not common for the head shape to revert back to its original shape. As children get older, they spend more time sitting, crawling and walking, which minimizes the amount of time they spend on their backs. In fact, further skull shape improvement may occur over time. If your child was diagnosed with torticollis, it may be necessary to continue the stretching program to maintain correction achieved by the Ballert Helmet.
Where can I get more information?
There is a wonderful discussion group that is primarily composed of parents at a website called www.plagiocephaly.org. Additional information is available on our Related Sites page and by searching the Internet with the keyword “plagiocephaly.”
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