Helmet therapy in infants with positional skull deformation: randomised controlled trial

Renske M van Wijk, Leo A van Vlimmeren, Catharina G M Groothuis-Oudshoorn, Catharina P B Van der Ploeg, Maarten J Ijzerman, Magda M Boere-Boonekamp, Renske M van Wijk, Leo A van Vlimmeren, Catharina G M Groothuis-Oudshoorn, Catharina P B Van der Ploeg, Maarten J Ijzerman, Magda M Boere-Boonekamp

Abstract

Objective: To determine the effectiveness of helmet therapy for positional skull deformation compared with the natural course of the condition in infants aged 5-6 months.

Design: Pragmatic, single blinded, randomised controlled trial (HEADS, HElmet therapy Assessment in Deformed Skulls) nested in a prospective cohort study.

Setting: 29 paediatric physiotherapy practices; helmet therapy was administered at four specialised centres.

Participants: 84 infants aged 5 to 6 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 helmet therapy (n=42) or to natural course of the condition (n=42) according to a randomisation plan with blocks of eight.

Interventions: Six months of helmet therapy compared with the natural course of skull deformation. In both trial arms parents were asked to avoid any (additional) treatment for the skull deformation.

Main outcome measures: The primary outcome was change in skull shape from baseline to 24 months of age assessed using plagiocephalometry (anthropometric measurement instrument). Change scores for plagiocephaly (oblique diameter difference index) and brachycephaly (cranioproportional index) were each included in an analysis of covariance, using baseline values as the covariate. Secondary outcomes were ear deviation, facial asymmetry, occipital lift, and motor development in the infant, quality of life (infant and parent measures), and parental satisfaction and anxiety. Baseline measurements were performed in infants aged between 5 and 6 months, with follow-up measurements at 8, 12, and 24 months. Primary outcome assessment at 24 months was blinded.

Results: The change score for both plagiocephaly and brachycephaly was equal between the helmet therapy and natural course groups, with a mean difference of -0.2 (95% confidence interval -1.6 to 1.2, P=0.80) and 0.2 (-1.7 to 2.2, P=0.81), respectively. Full recovery was achieved in 10 of 39 (26%) participants in the helmet therapy group and 9 of 40 (23%) participants in the natural course group (odds ratio 1.2, 95% confidence interval 0.4 to 3.3, P=0.74). All parents reported one or more side effects.

Conclusions: Based on the equal effectiveness of helmet therapy and skull deformation following its natural course, high prevalence of side effects, and high costs associated with helmet therapy, we discourage the use of a helmet as a standard treatment for healthy infants with moderate to severe skull deformation.

Trial registration: Current Controlled Trials ISRCTN18473161.

Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

Figures

https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4793693/bin/vanr017068.f1_default.jpg
Fig 1 Flowchart of HElmet therapy Assessment in Deformed Skulls study
https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4793693/bin/vanr017068.f2_default.jpg
Fig 2 Plagiocephalometry and cut-off points for severity of skull deformation. Illustration shows left occipital flattening of skull and thermoplastic measuring ring with digitally drawn lines used in plagiocephalometry. Indices were calculated by the following formulas: cranioproportional index, sinistra-dextra/anterior-posterior×100%; oblique diameter difference index, longest oblique diameter/shortest oblique diameter×100%; and ear deviation index, ear deviation/anterior-posterior×100%

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