Craniocervical Orthosis Produced Using 3D Printing Technology for Anterior Head Tilt Posture and Thoracic Kyphosis: A Custom-Manufactured Device Pilot Application Study

Forward head posture (FHP) is common in young adults using technological devices and often accompanied by increased thoracic kyphosis. This study reports the design and custom manufacturing of a 3D-printed craniocervical orthosis and a pilot application evaluating its effects on the craniocervical angle (CVA), thoracic kyphosis angle (TKA), and user satisfaction. In this prospective, single-arm, within-subject pilot study, each participant underwent 3D scanning, and a custom orthosis was manufactured from their scan data using a common three-point CAD template via FDM 3D printing. Ten volunteers aged 18–25 years completed the study without a priori sample size calculation. The CVA and TKA were assessed photogrammetrically at baseline and weeks 2, 4, and 6, under orthosis-assisted and non-assisted conditions, with devices iteratively adjusted over six weeks. Satisfaction was evaluated at follow-up completion using the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0-TR), and data were analyzed using a linear mixed model. Of the 13 individuals screened, 10 completed the protocol (one discontinued owing to discomfort and two withdrew voluntarily); no serious adverse events occurred. The CVA was significantly higher, and the TKA significantly lower, under the orthosis condition at every time point (all p < 0.001), reflecting an acute, device-on effect rather than a demonstrated lasting, unassisted postural correction. Mean device satisfaction was 4.88 ± 0.12/5 and mean service satisfaction was 5.00 ± 0.00/5 among the 10 completers; these scores exclude the participant who discontinued owing to discomfort and two who withdrew for unrelated reasons, which likely inflates the apparent satisfaction level. The custom-manufactured orthosis was feasible to design and fabricate, tolerable after iterative adjustment, and associated with improved craniocervical and thoracic alignment when worn; these findings reflect an acute, device-on effect and do not yet establish lasting postural correction without the orthosis. Given the single-arm, non-blinded pilot design, findings are preliminary and hypothesis-generating, supporting further confirmatory trials.