What is a cranial helmet?
A helmet is an orthotic brace, also called a cranial molding orthoses (CMO), that is used to help align cranial bones in children ages 3-18 months. Generally, CMO are used when head asymmetry has not been corrected using conservative treatment (positioning and physical therapy).
How does a helmet work?
CMO channel head growth by using passive resistance on prominent areas of the skull in order to direct skull growth toward the flattened areas. The orthotist fits the helmet and makes adjustments as the child grows.
CMO are custom-made based on the child’s unique head measurement, fabricated of rigid plastic with soft interface material; it is not the same as a protective helmet (as sometimes used for special circumstances).
What are the age recommendations?
Age recommendations: Food and Drug Administration (FDA)=3-18 months; American Academy of Pediatrics (AAP)=4-12 months; Yoo=4-9 months; Kluba=5-6 months.
CMO rely on cranial growth to correct skull asymmetry. Cranial growth slows after 32 weeks (7.2 months). After age 18 months, the FDA requires a Letter of Medical Necessity for helmets because correction is less likely to be effective. Helmets are standard treatment, not investigational.
Treatment of plagiocephaly is time-sensitive and best outcomes are achieved when the condition is identified and treated early. Torticollis is strongly associated with plagiocephaly and is an independent factor in the failure of conservative treatment for plagiocephaly; if torticollis is present, the child should receive treatment under the care of their PCP and/or therapist.
What is the process for getting a head shape evaluation?
We accept referrals from primary care providers, specialists and therapists. Children may be evaluated without a referral, but we will communicate the results with the child’s PCP. Only a provider with prescriptive authority can prescribe a CMO, we do not prescribe helmets.
How is the head measured?
We measure the head using hand measurements, and the Starscanner (Orthomerica Starscanner Laser Data Acquisition System). We have the only Starscanner in southern NM and west TX; Carrie Tingley Hospital in Albuquerque also uses this system.
The Starscanner is FDA regulated so clinics must comply with US Code of Federal Regulations and have annual certification. This diagnostic tool is non-invasive, non-radiation, and uses low-power eye-safe laser. It provides precise 3-D digital documentation of cranial symmetry in 2 seconds; electronic data is encrypted.
Who decides on helmet treatment?
Measurements are provided to parents/caregivers and the PCP, who determine whether helmet therapy is appropriate.
What to expect at your first appointment
- Your first appointment will last 1 hour. If your child is sick, we will reschedule. We do not charge for office visits.
- You will be asked to sign consent forms to allow us to photograph and scan your child’s head, and communicate with the PCP and insurance company.
- You are not charged for the scan, which is used by the PCP to determine whether your child needs a helmet. It is also used by your insurance company to determine whether they will authorize a helmet.
- Parents/caregivers and PCP must agree to proceed with helmet therapy. The PCP will be asked to rule out craniosynostosis (see Head Shape Info) and sign a prescription.
- If insurance is used, we will file a claim with your insurance company. The insurance approval process takes time, as long as 4-8 weeks. FDA requires helmets to be applied within 14 days of a scan. If the approval process takes longer, the child will need another scan.
- The Centers for Medicare and Medicaid Services (CMS) currently does not have a National Coverage Determination for helmets to treat plagiocephaly or surgically corrected craniosynostosis. Most states such as NM provide helmets to help their children, however there are a few exceptions such as TX. Medicare Coverage Database
- One insurance provider, Presbyterian NM, requires a pediatric neurologist to rule out craniosynostosis and sign the prescription.
- After treatment is authorized, we will proceed with ordering the helmet. The parents will select the helmet color and pattern (Orthomerica patterns).
What we expect before helmet therapy starts
- Parents/caregivers must agree to comply with the treatment regimen. This is a very important consideration for us. If you can NOT comply with this treatment regimen, for whatever reasons, then we should not begin helmet therapy.
- Other caregivers (family, friends, daycare personnel) must be willing to comply with the treatment regimen.
- Parents/caregivers must adhere to the helmet wear schedule, and start/stop treatment as recommended. Early discontinuation of treatment against medical advice may result in incomplete correction of the head shape; conversely, continued use of the helmet against medical advice may restrict skull growth.
- Please notify us ahead of time if an appointment must be rescheduled. Throughout this process, we ask parents/caregivers to call us with any questions or concerns.
The treatment time-frame is usually 4-6 months, although certain cases may require less or more time. The duration of helmet therapy is based on the age of your child and their particular head shape asymmetry.
Initial appointment and cranial scan (1 hour); initial helmet fitting (1 hour); follow-up visit at 2 weeks (15-30 min); follow-up every 4 weeks or as needed (15-30 min); follow-up with comparison scan (30-45 min); final visit with comparison scan (30-45 min).
Initial Wear Schedule
- Day 1: Three times during the day, alternate 1 hour on, 1 hour off, but not during naps or at night. Do scalp check (see guidelines below).
- Day 2: Three times during the day, alternate 2 hours on, 2 hours off, but not during naps or at night. Do scalp check.
- Day 3: Two times during the day, alternate 4 hours on, 4 hours off, but not during naps or at night. Do scalp check.
- Day 4: Two times during the day, alternate 8 hours on, 8 hours off, including during naps and at night. Do scalp check. First night to sleep in helmet.
- Day 5: Full time wear except for 1 hour, usually during bath time; you may split this hour up, 30 minutes AM and PM. You will continue this schedule until the end of the treatment period.
Ongoing Wear Schedule
Ideally, your child will wear the helmet for 23 hours/day. The wear schedule may be adjusted to accommodate issues that arise, such as fever. Please call our office before you adjust the wear schedule. We will need to return to full time wear as soon as possible.
The helmet may be removed during exercise therapy for torticollis. Remove the helmet if your child has a fever. If your child has not been able to wear the helmet for 48 hours, it is best to increase the wear schedule slowly over a few days.
Scalp Check guidelines:
- Check the scalp and clean the helmet interior often during the day.
- Check the entire scalp in good light, move hair aside. Check for red spots, rash, dry flaky skin, or blisters. Clean areas and allow to dry thoroughly.
- Check the helmet interior for discoloration or odor, clean and allow to dry thoroughly.
Red spots: “Normal” red spots should disappear within an hour after removing the helmet. Red spots can lead to skin breakdown and should be cleaned and monitored frequently during the day.
Perspiration: Your child may perspire more while adjusting to the helmet during the first several days. This is normal, keep your child cool and dress in cool clothing. Remove the helmet for a few minutes throughout the day, dry the head and helmet with a towel and reapply helmet. Time out of the helmet should be less than 10 minutes.
For moisture or perspiration, a thin cotton interface may be placed between the helmet and scalp to absorb sweat. The best material is very thin 100% cotton such as cotton sheeting, or hospital newborn caps; do not use terrycloth or bulky material. These cotton interfaces can be washed daily and reused.
Swimming: Remove the helmet for swimming. Keep the helmet dry, do not immerse in water. After swimming, shampoo child’s skin and hair to remove chlorine, sunscreen, etc. Reapply the helmet after the hair is completely dry.
Other causes of skin irritation or skin reaction:
- Bacterial infection, or a fungal (yeast) infection. These can be picked up anywhere that children play. A bacterial infection is treated very differently from a fungal infection; also, an infection may be a combination of bacterial and fungal. Therefore, it is important to contact your child’s PCP to make the correct diagnosis. If the infection is bacterial, the PCP may prescribe a topical antibiotic such as neosporin if your child has no allergy. If the infection is fungal, an antifungal medication may be prescribed. It is important to remember that using some medications under an occluded helmet may effectively increase the dose concentration.
- Sensitivity to powders, lotions, or wipes that contain perfumes or other ingredients
- Allergic reaction to the cleaning agent used to clean the helmet interior, such as alcohol
- Allergic reaction to medications, food, pets, molds, or seasonal allergies
- Sensitivity to new environments such as day care, church, or homes
If you notice a skin breakdown, please contact our office to describe the problem, or take a picture and email it to us. We may ask questions about recent changes in your child’s routine (such as new soap, shampoo, diet, medication or environment). We may ask you to come to the office to adjust the helmet to relieve the area that is in contact with the skin, or adjust the wear schedule to allow the skin to heal.
For a problem that does not resolve, or for any medical treatment, we encourage you to contact your child’s PCP.
- You may decorate the exterior of your helmet. However, only the orthotist can modify the interior and exterior of the helmet.
- Keep the helmet dry, do not immerse in water.
- Do not apply decorative stickers that the child can peel off, this is a choking hazard.
- The helmet has a chafe strap and a stop-gap foam insert. Make sure these are secure because loose parts are a choking hazard and can cause asphyxiation if the parts are swallowed.
- Every time you remove the helmet, either for bath or for scalp check, clean the helmet. Use rubbing alcohol unless your child is allergic; you may use vinegar and water. Apply with a clean washcloth or cotton gauze, or spray on the rubbing alcohol with a mister, and rub the helmet liner.
- Do not use other cleaning products such as baby wipes or antiseptic wipes. These may cause deterioration of the helmet foam, and worse, may be harmful to the baby’s skin, cause an allergic reaction or skin breakdown.
- Normal helmet wear and tear includes discoloration and odor. Drying in the sun may help alleviate odor. A baking soda solution may be used but must be completely rinsed out to avoid a scalp reaction.
- Keep a small bottle of rubbing alcohol (or vinegar and water) and cotton gauze or washcloth in your car or diaper bag. You will be prepared to clean the helmet when you travel, even just for errands.
- After cleaning, allow the helmet to dry completely. Use a fan or dry in the sun if needed as residual moisture can cause skin problems.
- Do not use a hair dryer to dry the helmet as it can melt the plastic foam.
- Keep the helmet away from family pets as dogs have been known to chew the plastic and foam liner. This does happen!
End of treatment
- It is best to taper off helmet wear at the end of treatment. Allow time for your child to adapt to receiving sensory information without a helmet. For example, since their head has been protected from impacts, they must learn to avoid hitting their head.
- Contact our office for follow-up, questions or concerns.
STARscanner information: Orthotic Management of Pediatric Cranial Deformities Using STAR Cranial Remolding Orthoses
Additional information at the Orthomerica website: Frequently Asked Questions by Parents
Ridgway EB, Weiner HL. Skull Deformities. Pediatr Clin N Am 51 (2004) 359–387.
Seruya M, Oh AK, Taylor JH, Sauerhammer TM, Rogers GF. Helmet Treatment of Deformational Plagiocephaly: The Relationship between Age at Initiation and Rate of Correction. Plastic & Reconstructive Surgery. 2013 January;131(1):55e–61e.
Yoo HS, Rah DK, Kim YO. Outcome Analysis of Cranial Molding Therapy in Nonsynostotic Plagiocephaly. Arch Plast Surg. 2012 Jul;39 (4):338-44. Epub July 13, 2012.
Kluba S, Kraut W, Reinert S, Krimmel M. What is the Optimal Time to Start Helmet Therapy in Positional Plagiocephaly? Plast Reconstr Surg. 2011 Aug;128(2):492-8.
Steinberg JP, Rawlani R, Humphries LS, Rawlani V, Vicari FA. Effectiveness of conservative therapy and helmet therapy for positional cranial deformation. Plast Reconstr Surg. 2015;135(3):833.
Laughlin J, Luersses TG, Dias MS. Prevention and management of positional skull deformities in infants. Pediatrics. 2011 Dec;128(6).
Hagan J, Shaw J, Duncan P. Bright Futures: Guidelines for Health Supervision of Infants, Children, and Families. 2008. American Academy of Pediatrics.
Department of Health and Human Services: Food and Drug Administration. Code of Federal Regulations (CFR) Title 21, Volume 8, Chapter 1, Subchapter H Medical Devices Part 882 Subpart F Neurological Therapeutic Devices 21CFR882.5970 Cranial Orthosis.