Anita Liberman-Lampear, MA, president of the American Orthotic & Prosthetic Association (AOPA), submitted a letter to The New York Times (NYT) expressing concern about an article the paper had published citing a study that discouraged the use of helmet therapy as a standard treatment for healthy infants with moderate to severe skull deformation. She told NYT that the study related to a “narrow group of patients,” those with mild to moderate indicators of positional skull deformation, and that “independent published research that has examined the effectiveness of helmet therapy has concluded that as many as 95 percent of patients demonstrated an improvement in head shape symmetry after helmet therapy.”
The study referred to in the NYT article, “Helmet Therapy in Infants with Positional Skull Deformation: Randomised Controlled Trial,” was published online May 1 in BMJ, an open-access, peer-reviewed journal. The study authors, a research team from Netherlands, conducted a pragmatic, single-blinded randomized controlled trial nested in a prospective cohort study. The cohort consisted of 84 infants age five to six months with moderate to severe skull deformation, who were born after 36 weeks of gestation and had no muscular torticollis, craniosynostosis, or dysmorphic features. Participants were randomly assigned to six months of helmet therapy (n=42) or to natural course of the condition (n=42) according to a randomization plan with blocks of eight. In both trial groups, parents were asked to avoid any additional treatment for the skull deformation.
The change score for both plagiocephaly and brachycephaly was equal between the helmet therapy and natural course groups, and full recovery was achieved in ten of 39 (26 percent) participants in the helmet therapy group and nine of 40 (23 percent) participants in the natural course group. All parents reported one or more side effects, listed as skin irritation, pain, sweating, odor of the helmet, problems with accepting the helmet, and feeling hindered in cuddling because of the helmet. Based on what the study authors called equal effectiveness of helmet therapy and skull deformation following its natural course, and given the high prevalence of side effects and high costs associated with helmet therapy, they discourage the use of a helmet as a standard treatment for healthy infants with moderate to severe skull deformation.
In the NYT article, makers of custom helmets were also interviewed. A spokesperson for Cranial Technologies, with 17 locations across the United States, called the results “inherently flawed,” while a spokesperson for Orthomerica, Orlando, Florida, said it was “alarming” that almost 75 percent of the parents of the helmet therapy group reported that the helmets shifted or rotated on their infants’ heads. “The value of this research is fully reliant upon the quality of the fit,” James Campbell, vice president of AOPA, told NYT.
