Computer-aided design methods for digitizing the foot and ankle orthoses manufacturing workflow: A scoping review

Ankle foot orthoses (AFOs) and foot orthoses (FOs) are 2 commonly prescribed lower limb orthoses. Traditionally produced using artisanal methods, the design and manufacture of these devices have increasingly used computer-aided design (CAD) and computer-aided manufacturing technologies in recent decades. The CAD workflows can vary considerably, making generalization of research findings difficult. In this scoping review, research studies of any design that reported using CAD to produce designs for AFOs or FOs were eligible for inclusion. The review was developed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR). Six electronic databases were searched till December 2024. Seventy-three articles were included in this review. A wide range of CAD programs was used to produce orthotic devices; however, the procedures and reproducibility of the design processes were poorly or not at all described in 46.6% of the included articles. A mix of general-purpose and orthotic-specific CAD software was recorded, with SolidWorks and Rhinoceros being the most popular options. OrthoModel and Rodin4D were the most reported currently available orthotic-specific CAD software for FOs and AFOs, respectively. The CAD operation time for general-purpose software was generally longer than that for orthotic-specific ones. In addition, we have developed a checklist to assist in standardizing and ensuring reproducibility of FOs and AFOs studies. Researchers, clinicians, and those in industry need to exchange their knowledge to help address real-world need, enhance CAD functionalities, and support CAD programs in clinical studies.