Gait assessment during the initial fitting of customized selective laser sintering ankle foot orthoses in subjects with drop foot

Background: Recently, additive fabrication has been proposed as a feasible engineering method for manufacturing of customized ankle foot orthoses (AFOs). Consequently, studies on safety, comfort and effectiveness are now carried out to assess the performance of such devices. Objective: Evaluate the clinical performance of customized (selective laser sintering) SLS-AFOs on eight subjects with unilateral drop foot gait and compare to clinically accepted (polypropylene) PP-AFOs. Study Design: Active control trial. Methods: For each subject two customized AFOs were fabricated: one SLS-AFO manufactured following an additive fabrication framework and one thermoplastic PP-AFO manufactured according to the traditional handcraft method. Clinical performance of both AFOs was evaluated during gait analysis. Results: A significant beneficial effect of both custom-moulded PP-AFO and customized SLS-AFO in terms of spatial temporal gait parameters and ankle kinematic parameters compared to barefoot gait of adults with drop foot gait are observed. No statistically significant difference between the effect of PP-AFO and of SLS-AFO was found in terms of spatial temporal gait parameters and ankle kinematic parameters. Conclusion: AFOs manufactured through the SLS technique show performances that are at least equivalent to the hand-crafted PP-AFOs commonly prescribed in current clinical practice.