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Inicio  /  Applied Sciences  /  Vol: 12 Par: 9 (2022)  /  Artículo
ARTÍCULO
TITULO

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

Paolo Caravaggi    
Alessandro Zomparelli    
Giulia Rogati    
Massimiliano Baleani    
Roberta Fognani    
Franco Cevolini    
Cristina Fanciullo    
Arianna Cinquepalmi    
Giada Lullini    
Lisa Berti and Alberto Leardini    

Resumen

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.