Purpose: Plagiocephaly is an asymmetrical appearance of the head caused by either intrinsic or extrinsic forces or events. Intrinsic forces include craniosynostosis and hydrocephalus. Extrinsic forces include gravity due to positioning. Positional plagiocephaly is secondary to extrinsic forces and defined as an asymmetrical head shape in an infant of nonsynostotic origin due to a variety of prenatal or postnatal causes. We have developed a pneumatic orthotic cranial molding helmet for correcting positional plagiocephaly. This helmet utilizes a novel method of skull orthosis using a clear band with clear internal pneumatic inflated bladders to exert monitored external forces on the calvarium through the scalp. These forces are similar to the forces that a child will induce from the weight of the craniofacial skeleton while laying on a firm surface. By mimicking these forces, we are inducing cranial growth directions that are desirable to produce near normal skull shapes. Our project will formally examine the results of the orthotic cranial molding helmet in patients with positional plagiocephaly.

Methods: All patients diagnosed with positional plagiocephaly and have been custom fitted by the Orthotics and Prosthetics Department for the helmet were eligible for inclusion. Diagonal cranial lengths were routinely measured at each visit. Patients must have had at least two separate measurements. Pressures in the air bladders were applied by an air pump (20-25 mmHg) to assist in directional control of cranial growth. This pressure was determined by the average gravitational force exerted by an infant cranium against a hard surface (unpublished data). Analysis investigated the change in the ratio of oblique cranial measurements over time as evidenced by multiple orthotic follow-up appointments. Analysis also included the ratio change as compared to the patient’s age and head circumference.

Results: There were 75 patients that met inclusion criteria (50 males, 25 females). 66% had right posterior plagiocephaly, 26% had left posterior plagiocephaly, and 8% had unspecified plagiocephaly. Mean age at initial visit was 178 days. Average length of treatment was 96 days. Patients with pneumatic orthotic cranial molding helmet therapy had significantly improved outcomes (equalizing oblique rations) as compared with pretreatment measurements. The helmet did not limit cranial growth as evidenced by significant normalization of the oblique measurement ratio when compared to increasing cranial circumference and age (p=0.0003, p=<0.0001 respectively).

Conclusion: The pneumatic orthotic cranial molding helmet successfully corrects positional plagiocephaly and does not hinder normal cranial growth. This unique therapy uses monitored air bladders to mimic natural gravitational forces to actively remold the cranium.