Cranial Orthosis Therapy for Plagiocephaly: an RCT Pilot Study Comparing Cranial Orthosis to the Natural Course

Our research endeavors to examine the feasibility of implementing a randomized controlled trial (RCT) that evaluates the efficacy of cranial orthosis therapy in addressing severe deformational plagiocephaly among infants aged 4 to 7 months. Primary Objective: The central focus is on evaluating the feasibility aspects associated with the RCT design within our clinical setting. Participants: Infants meeting the inclusion criteria will be recruited and randomized into two distinct groups: 1. Treatment Group: Receiving cranial orthosis therapy initiated one week post their initial physiatrist visit. 2. Control Group: Adhering to the standard of care, with cranial orthosis initiation at 7 weeks post their initial physiatrist visit. Study Procedures: Participants in both groups will undergo a structured series of assessments and interventions, including: * Head measurements and 3D-scan evaluations to quantify cranial deformities. * Helmet adjustments by experienced orthotists based on growth and changes in head shape. * Regular medical follow-ups, totaling four visits during the course of the study. Post-Treatment Assessments: Upon completion of the cranial orthosis therapy, participants will be required to fill out post-treatment questionnaires, providing valuable insights into their experiences, satisfaction levels, and any potential concerns