Development of a Novel Passive-Dynamic Custom AFO for Drop-Foot Patients: Design Principles, Manufacturing Technique, Mechanical Properties Characterization and Functional Evaluation

Ankle foot orthoses (AFOs) are medical devices prescribed to support the foot and ankle of drop-foot patients. Passive-dynamic AFOs (PD-AFOs) are an effective solution for less severe cases. While off-the-shelf PD-AFOs are rather inexpensive, they provide poor anatomical fit and do not account for the required patient-specific biomechanical support. Three-dimensional (3D) scanning and manufacturing technologies allow manufacturing PD-AFOs customized for the patient's anatomy and functional needs. This paper aimed to report the overall procedure for designing and manufacturing a novel, fiberglass-reinforced polyamide, custom PD-AFO. The feasibility of the proposed procedure was tested in a case study. The methodology can be divided into the following steps: (i) foot and leg scanning, (ii) 3D design, and (iii) additive manufacturing via selective laser sintering. A custom PD-AFO was designed and manufactured for a 67-year-old male drop-foot patient following paraparesis in severe discarthrosis after spine stabilization surgery. AFO mechanical properties were measured via an ad hoc setup based on a servohydraulic testing machine. The functional outcome was assessed via gait analysis in three conditions: shod (no AFO), wearing an off-the-shelf PD-AFO, and wearing the patient-specific PD-AFO. As expected, wearing the PD-AFO resulted in increased ankle dorsiflexion in the swing phase with respect to the shod condition. Sagittal rotations of the hip, knee, and ankle joints were similar across PD-AFO conditions, but the custom PD-AFO resulted in faster walking speed with respect to the off-the-shelf (walking speed: 0.91 m/s versus 0.85 m/s). Additionally, the patient scored the custom PD-AFO as more comfortable (VAS score: 9.7 vs. 7.3). While the present analysis should be extended to a larger cohort of drop-foot patients, the novel PD-AFO seems to offer a valid, custom solution for drop-foot patients not satisfied with standard orthotics.