Cranial Remolding Orthosis Study on the Use of a Temperature Sensor to Measure Wear Time

Abstract

ABSTRACT Introduction The effectiveness of cranial remolding orthoses (CROs) in treating nonsynostotic deformational plagiocephaly (DP) is anecdotally related to adherence. Efficacy of CROs has been evaluated but lacks evidence regarding necessary wear time to achieve a positive outcome. A 23 hr/d wear schedule is generally prescribed regardless of presentation. The study compares daily wear time to treatment outcomes. Materials and Methods Subjects Infants aged 3–18 months diagnosed with DP were included with initial cranial vault asymmetry (CVA) > 6 mm or cephalic ratio (CR) > 0.90. Subjects were treated with an Orthomerica STARband CRO. A total of 106 subjects enrolled, with 69 completed. Apparatus A questionnaire assessed caregiver’s reported adherence with the CRO. Maximum Integrated’s iButton temperature loggers (iButtons) recorded objective wear time. Procedures 3D head shape measurements via Orthomerica STARScanner, caregivers’ questionnaires, and iButton data were collected every 5–8 weeks. Data Analysis Descriptive statistics were obtained, and data reported as mean ± SD or median [25th, 75th percentiles]. Nonparametric sign tests were used to assess differences from CRO fabrication scan to subsequent follow-ups. Spearman rank correlations and corresponding 95% confidence intervals and P values between average wear time and change of measurements were obtained. Results Self-reported wear time was 22 (22, 23) hrs/d. Measured wear time was 17–18 (12, 20) hrs/d. Longer average wear time was significantly associated with larger reductions in CVA (P = 0.0054), CR (P = 0.0080), and CVAI (P = 0.0059). Conclusions Results showed longer average daily wear increased effectiveness in CRO treatment of plagiocephaly. Increased sample sizing is required to determine if generalizable to brachycephalic and asymmetrical brachycephalic head shapes. Clinical Relevance A CRO wear schedule of 23 hrs a day is currently recommended, but difficult for families to adhere. The impact of the study may indicate a more realistic wear schedule that would improve adherence while achieving optimal outcomes.