Pegah Amir-Yazdani, Rasha Alhaeik, Marisol Gimeno, Katy Fontaine, Andrei Bursuc, Alexander G Weil, Camille K Costa

FEASIBILITY OF A PILOT RANDOMIZED CONTROLLED TRIAL ON CRANIAL REMOLDING ORTHOSIS FOR SEVERE DEFORMATIONAL PLAGIOCEPHALY

Introduction

Feasibility of a pilot randomized controlled trial on cranial remolding orthosis for severe deformational plagiocephaly. This pilot RCT evaluates the feasibility of cranial remolding orthosis for severe infant plagiocephaly. It confirms successful implementation, high parental satisfaction, and head shape improvement.

Abstract

BACKGROUND: Prevalence of deformational plagiocephaly (DP) has increased since the “Back to sleep” campaign to counter sudden infant death syndrome. Cranial remolding orthosis (CRO) is commonly used to manage severe DP in infants, yet evidence from randomized controlled trials (RCT) remains limited. OBJECTIVES: This pilot RCT aimed to assess the feasibility of a future large-scale RCT on cranial remolding orthosis for severe DP in infants aged 4 to 7 months. Specific objectives included evaluating recruitment, retention, coordination, and parental acceptability. A secondary objective was exploring trends in cranial shape outcomes between groups over 6- and 12-week periods. METHODOLOGY: Seventy-eight infants were screened at a single pediatric tertiary-care center between December 2023 and June 2024, and 31 families were approached for consent after initial clinical evaluation. Following consent, head shape severity was assessed using three-dimensional surface imaging, and seven infants were excluded prior to randomization due to insufficient severity. Twenty-four infants were randomized to receive immediate (n = 12) or delayed (six-week delay) (n = 12) CRO. One participant randomized to the delayed arm received the orthosis earlier than planned due to a protocol deviation. Feasibility metrics included recruitment timelines, protocol adherence, appointment coordination, and parental acceptability. Exploratory efficacy analyses evaluated cranial vault asymmetry (CVA), cranial vault asymmetry index (CVAI), oblique diameter diagonal difference (ODDI), cranioproportional index (CI), Argenta severity scores, and parent-reported head shape perception and satisfaction. FINDINGS: Of the 24 randomized infants, 20 were male and four were female. Mean age at enrollment was 5.3 ± 0.9 months in the intervention arm and 5.1 ± 0.9 months in the control arm. Recruitment and retention targets were met within seven months despite scheduling challenges. Parental satisfaction was high (mean score of 4.5 ± 0.1 on a 5-point scale), and all families reported willingness to repeat treatment despite common but minor side effects, including sweating, orthosis odor, and mild skin irritation. Significant improvements over time were observed in CVA, ODDI, and CI (all p < 0.001), with no significant between-group differences observed at 6 or 12 weeks. CONCLUSION: This pilot trial confirmed the feasibility and acceptability of conducting a larger RCT on CRO for DP, demonstrating successful recruitment, retention, and protocol implementation. Cranial symmetry improved over time in both groups, with no statistically significant differences observed between immediate and delayed treatment arms over the 12-week period. Future larger studies are needed to assess clinical effectiveness and should consider broader inclusion criteria, refined measurement techniques, and dedicated coordination to address scheduling challenges and ensure rigorous implementation and generalizability. Layman's Abstract Certain babies develop a flattened head shape, known as deformational plagiocephaly, when they spend long periods lying on their backs. This head shape has become more frequent since the recommendation for babies to sleep on their backs was introduced. Milder cases often improve over time, but severe cases may need a custom-made helmet (cranial remolding orthosis) to reshape the skull. This study tested whether it would be doable to conduct a larger clinical trial to evaluate how well helmet therapy works for infants with severe head flattening. Of 78 children screened, 31 infants were recruited, of whom 24 infants aged 4 to 7 months met eligibility criteria after head shape confirmation using three-dimensional imaging. Twelve infants started helmet therapy immediately, and 12 began treatment after a six-week delay. The study assessed ease of family recruitment and assignation to either group, ease of study coordination, how acceptable the treatment was to parents, and if measurable changes in head shape could be detected after 6 and 12 weeks. Recruitment and follow-up were successful, and parents reported high satisfaction with treatment despite minor, temporary side effects such as sweating, helmet odor, or mild skin irritation. Head shape improved in both groups over time, but no differences were seen between infants who started helmet therapy immediately versus after a six-week delay, suggesting that no clear short-term advantage of starting treatment earlier was observed in this pilot study. These results show that a larger study on helmet therapy for severe deformational plagiocephaly is doable and acceptable to families. Future research should include a broader range of infants and use refined measurement techniques to better determine helmet therapy effectiveness. Article PDF Link: https://jps.library.utoronto.ca/index.php/cpoj/article/view/46298/34762 How To Cite: Amir-Yazdani P, Alhaeik R, Gimeno M, Fontaine K, Bursuc A, Weil A.G, et al. Feasibility of a pilot randomized controlled trial on cranial remolding orthosis for severe deformational plagiocephaly. Canadian Prosthetics & Orthotics Journal. 2026; Volume 9, Issue 1, No. 1. https://doi.org/10.33137/cpoj.v9i1.46298 Corresponding Author: Pegah Amir-Yazdani, MDAffiliation: 1) Department of Pediatrics, Division of Physical Medicine and Rehabilitation, Faculty of Medicine, Centre hospitalier universitaire Sainte-Justine, Montreal, Canada; 2) Faculty of Medicine, University of Montreal, Montreal, Canada.E-Mail: pegah.amir.yazdani@umontreal.caORCID ID: https://orcid.org/0009-0006-9088-1623

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