Evaluation of novel plantar pressure-based 3-dimensional printed accommodative insoles - A feasibility study. (August 2022)

• Record Type: Journal Article
• Authors: Muir, Brittney C.; Li, Jing-Sheng; Hudak, Yuri F.; Kaufman, G. Eli; Cullum, Scott; Aubin, Patrick M.
• Is Part Of: Clinical biomechanics. Volume 98(2022)
• Publication Date: 2022-08
• Subjects: Personalized metamaterials (PMM) -- Diabetic insoles -- 3D printed diabetic insoles -- Plantar pressure -- Pressure time integral; Biomechanics -- Periodicals; Osteopathic medicine -- Periodicals; Biomechanics -- Periodicals; Osteopathic Medicine -- Periodicals; 612.76
• DOI: 10.1016/j.clinbiomech.2022.105739
• Languages: English
• ISSNs: 0268-0033

Abstract

Abstract: Background: Custom insoles are commonly prescribed to patients with diabetes to redistribute plantar pressure and decrease the risk of ulceration. Advances in 3D printing have enabled the creation of 3D-printed personalized metamaterials whose properties are derived not only from the base material but also the lattice microstructures within the metamaterial. Insoles manufactured using personalized metamaterials have both patient-specific geometry and stiffnesses. However, the safety and biomechanical effect of the novel insoles have not yet been tested clinically. Methods: Individuals without ulcer, neuropathy, or deformity were recruited for this study. In-shoe walking plantar pressure at baseline visit was taken and sensels with pressure over 200 kPa was used to define offloading region(s). Three pairs of custom insoles (two 3D printed insoles with personalized metamaterials (Hybrid and Full) designed based on foot shape and plantar pressure mapping and one standard-of-care diabetic insole as a comparator). In-shoe plantar pressure measurements during walking were recorded in a standardized research shoe and the three insoles and compared across all four conditions. Findings: Twelve individuals were included in the final analysis. No adverse events occurred during testing. Maximum peak plantar pressure and the pressure time integral were reduced in the offloading regions in the Hybrid and Full but not in the standard-of-care compared to the research shoe. Interpretation: This feasibility study confirms our ability to manufacture the 3D printed personalized metamaterials insoles and demonstrates their ability to reduce plantar pressure. We have demonstrated the ability to modify the 3D printed design to offload certain parts of the foot using plantar pressure data and a patient-specific metamaterials in the 3D printed insole design. The advance in 3D printed technology has shown its potential to improve current care. Highlights: Two types of 3D-printed insoles with personalized metamaterials were designed. Both 3D-printed insoles reduced plantar pressure in offloading regions (>200 kPa). Both 3D-printed insoles did not induce any adverse events during testing. 3D-printed insoles show potential to improve the current standard of care.