Design principles, manufacturing and evaluation techniques of custom dynamic ankle-foot orthoses: a review study.

Ankle-Foot Orthoses (AFO) can be prescribed to allow drop-foot patients to restore a quasi-normal gait pattern. Standard off-the-shelf AFOs are cost-effective solutions to treat most patients with foot and ankle weakness, but these devices have several limitations, especially in terms of comfort. Therefore, custom AFOs are increasingly adopted to address drop-foot when standard solutions are not adequate. While the solid ones are the most common type of AFO, providing full stability and strong resistance to ankle plantarflexion, passive dynamic AFOs (PD-AFOs) represent the ideal solution for patients with less severe ankle weakness. PD-AFOs have a flexible calf shell, which can bend during the stance phase of walking and absorb energy that can be released to support the limb in the push-off phase. The aim of this review is to assess the state-of-the-art and identify the current limitations of PD-AFOs. An extensive literature review was performed in Google Scholar to identify all studies on custom PD-AFOs. Only those papers reporting on custom PD-AFOs were included in the review. Non peer-reviewed papers, abstract shorter than three pages, lecture notes and thesis dissertations were excluded from the analysis. Particular attention was given to the customization principles and the mechanical and functional tests. For each topic, the main results from all relevant papers are reported and summarized herein. There were 75 papers that corresponded to the search criteria. These were grouped according to the following macro-topics: 16 focusing on scanning technologies and geometry acquisition; 14 on customization criteria; 19 on production techniques; 16 on mechanical testing, and 33 on functional testing. According to the present review, design and production of custom PD-AFOs are becoming increasingly feasible due to advancements in 3D scanning techniques and additive manufacturing. In general, custom PD-AFOs were shown to provide better comfort and improved spatio-temporal parameters with respect to standard solutions. However, no customization principle to adapt PD-AFO stiffness to the patient's degree of ankle impairment or mechanical/functional demand has thus far been proposed.