Evaluating Patient Adherence to Cranial Orthosis Treatment Using Temperature Sensors and a Mobile Device Application

ObjectiveTo evaluate the feasibility of using temperature sensors and a mobile app to objectively measure cranial remodeling orthosis (CRO) wear time, assess adherence to the prescribed 23 h per day wear schedule, and examine the relationship between wear time and treatment outcomes.DesignProspective, multisite cohort study.SettingSix Cranial Technologies clinical sites across Arizona.Patients/ParticipantsInfants aged 3 to 18 months treated with a CRO equipped with a temperature sensor. A total of 87 infants who received a sensor were eligible for wear time analysis, and of those, 78 completed treatment with exit 3-dimensional imaging.Main Outcome Measure(s)Daily CRO wear time was objectively measured by a temperature sensor recording at 15-min intervals and changes in cranial shape, including cranial vault asymmetry index (CVAI(S)) and cephalic index (CI) were measured.ResultsThe average daily wear time was 15.9 ± 6.1 h across all infants and 18.0 h among those who completed treatment. No sensor-related complications occurred. Greater wear time was significantly associated with greater reduction in CVAI(S), but not CI, likely due to the small number of infants with brachycephaly. Notably, older infants derived significantly more benefit from increased wear time than younger infants.ConclusionsMeasuring CRO adherence using a temperature sensor with a mobile application is feasible and did not produce any observed safety concerns. Overall, the recorded average daily wear was lower than the prescribed treatment protocol, underscoring a gap between recommended and actual adherence.