Hold On There: A Longitudinal Study of Pressure Distribution and Shape Correction during Cranial Remolding Orthoses Therapy

Introduction: Cranial remolding orthosis (CRO) is theorized to establish holding and nonholding areas within the orthosis that either inhibit or promote targeted cranial growth. There is no clinically published data on the magnitude and change in pressures between the head and orthosis during cranial remolding therapy with a CRO. This study quantifies the CRO holding and nonholding pressures on head-mimics of infant patients undergoing cranial remolding treatment. Materials and Methods: Pressure distribution data were collected for six patients throughout their treatment for up to 17 weeks using surrogate head forms. Tekscan I-Scan sensors and software were used to quantify pressures within the head-CRO interface. Results: Holding quadrants experienced an average pressure of 2.37 (±1.10) kPa initially and 4.37 (±0.89) kPa at final measurements. Nonholding quadrants observed 1.27 (±0.92) kPa initially and 1.99 (±1.32) kPa at final treatment. There was a statistically significant difference in average pressures between holding and nonholding quadrants at both initial and final. Between initial and final treatments, a significant increase in average pressure was seen in holding quadrants. For holding quadrants, the peak pressure was 8.54 (±3.79) kPa at initial and 20.54 (±8.18) kPa at final measurements. For nonholding quadrants, the peak pressure was 5.28 (±2.97) kPa at the initial fitting and 9.84 (±4.51) kPa at the final treatment. There was a significant difference in peak pressures between holding and nonholding quadrants at the final measurement and a significant increase in peak pressures between initial and final treatments in holding quadrants. Conclusions: This study presented a novel pressure mapping procedure for data collection during infant cranial remolding treatment. The results provide a base understanding of pressures present at the head–CRO interface and will provide a better understanding of the mechanical basis for plagiocephaly correction, CRO treatment, and influence best-fit practices for clinicians. Clinical Relevance: There is currently no published data on pressures felt at the head–CRO interface. Providing clinicians with this quantitative benchmark pressure would allow for optimized remolding therapy, increasing the quality of patient care.