CRANIAL REMOLDING ORTHOSIS TREATMENT FOR INFANTS WITH ISOLATED DEFORMATIONAL PLAGIOCEPHALY: AN EXAMINATION OF THE EFFICACY OF TREATMENT

Purpose/Hypothesis: Cranial remolding orthoses (CROs) are used in the treatment of positional plagiocephaly. This original research examined the: a) overall efficacy of CROs for infants with isolated deformational plagiocephaly, b) predictive factors influencing treatment outcomes, c) clinician-rated success of treatment outcome, and d) pre-treatment versus post-treatment severity classification of head shape. The anthropometric measurements commonly used to quantify infant head shape include the Cephalic Index (CI), Cranial Vault Asymmetry (CVA), and the Cranial Vault Asymmetry Index – Shorter Diagonal Formula (CVAI(S)).

Number of Subjects: This study was a large retrospective review of N = 27, 990 infants, with isolated deformational plagiocephaly (IDP) and a CVAI(S) > 3.5 and a CI < 90%, who completed CRO treatment between July 1, 2014 – March 25, 2024, at Cranial Technologies®.

Materials/Methods: The participants in the study were stratified by age (3-4 months of age, 4-5 months of age, 6-7 months of age, 8-10 months of age, and 11 months up to 18 months of age) and by initial severity rating (Mild (CVAI(S)= 3.5 - 6.25), Moderate (CVAI(S )= 6.25 - 8.75), Severe (CVAI(S)= 8.75 - 11.0), and Very Severe (CVAI(S) > 11.0)).

Results: There was a significant overall mean change in CVAI(S)across all age groups of –3.42 +/- 1.87 (p < 0.001) for patients who were compliant with CRO treatment. The overall mean change in CVAI(S) was also significant within each of the age groups. Between 93.66% - 96.57% of infants aged 3-5 months at start of treatment achieved a “good” or “great” outcome rating by their treating clinician at the time of exit from treatment, regardless of their initial severity rating. For babies who started CRO treatment at greater than 11 months of age, between 48% - 77.6% exited treatment with a “good” or “great” outcome, with the clinician rating dependent upon their initial severity rating.

Conclusions: The following factors were significant predictors of change in CVAI(S): 1) younger age at initiation of treatment (p < 0.001, β = 0.01), 2) initial severity rating as measured by CVAI(S) (p < 0.00, β = -0.43), 3) left plagiocephaly (p < 0.001, β = - 0.36), and 4) and the presence of torticollis (p < .001, β = 0.17).

Clinical Relevance: Pediatric health care providers should be aware of the benefits of CRO therapy, the risk factors that may affect CRO outcomes, the need for a timely referral for CRO treatment, and that CROs are an effective, research-supported treatment method for positional plagiocephaly.