A Pilot Study Testing a Novel 3D Printed Amphibious Lower Limb Prosthesis in a Recreational Pool Setting

Abstract

Introduction Adults with limb amputation and other physical disabilities are less likely to participate in physical activity than adults in the general population and have elevated risk of heart disease and stroke. Swimming is a physical activity often recommended for persons with limb amputation. However, a standard economical swim prosthesis that facilitates easy transition from land to water does not exist. Objective The objectives were (1) to measure ease of first‐time use and likability of a novel U.S. Food and Drug Administration (FDA)–cleared 510(k) three‐dimensional (3D) printed device, the “FIN,” in a recreational pool; and (2) to determine differences in time to complete basic swim tasks using the novel 3D printed amphibious lower limb prosthesis or a standard Swim Ankle prosthesis. Our hypotheses were the following: (1) that the novel 3D printed amphibious lower limb prosthesis would be easy and likeable upon first use; and (2) that basic swim tasks would take comparable time to complete with either device. Setting Academic medical center and community pool in New York. Participants Participants were (N = 10) English‐speaking adults with a transtibial amputation who self‐identified to swim comfortably in a recreational setting. Interventions Participants completed tasks typical of recreational swimming while wearing the novel 3D printed amphibious lower limb prosthesis or a Swim Ankle. Main Outcome Measurements Participants performed a series of recreational swim tasks at self‐selected speeds: entering/exiting pool, walking, swimming, and treading water, and completed a survey to assess the primary outcomes: likability, ease of use, and adverse events (feasibility). Results Participants found the novel 3D printed amphibious lower limb prosthesis more likable compared to the Swim Ankle and easy to use. Time to exit the pool was significantly reduced with the novel 3D printed amphibious lower limb prosthesis, while time to complete a 25‐m lap was comparable. Participants did not show significant changes in vital signs when using either prosthesis. Conclusions The novel 3D printed amphibious lower limb prosthesis was likable and easy to use upon first use. This study supports conducting a larger clinical trial to determine if the data are broadly reproducible.

Additive manufacturing for prostheses development: state of the art

“…and their mechanical parameters (strength, materials, structure, geometry, weight or complexity) (Alqahtani et al , 2021; Goldstein et al , 2020; Guo Dong et al , 2020; Jarl et al , 2012; Stenvall et al , 2020). According to the evaluation, some participants in a recreational pool scenario found an additively manufactured lower limb prosthesis acceptable and straightforward (Goldstein et al , 2020). With the view to the application of composite materials in the development of prostheses, transtibial lower limb prosthesis had been fabricated using biocomposite materials (polypropylene-reinforced with micro-fibrillated cellulose) and FDM technology.…”

“…Prostheses are evaluated based on their functionality in various activities (walking, running, swimming, etc.) and their mechanical parameters (strength, materials, structure, geometry, weight or complexity) (Alqahtani et al , 2021; Goldstein et al , 2020; Guo Dong et al , 2020; Jarl et al , 2012; Stenvall et al , 2020). According to the evaluation, some participants in a recreational pool scenario found an additively manufactured lower limb prosthesis acceptable and straightforward (Goldstein et al , 2020).…”

Additive Manufacturing of Prostheses Using Forest-Based Composites

“…A recent scoping review [ 18 ] only found 11 articles that covered the implications of 3D printing in the field of lower limb amputation, but they concluded that it was a promising advancement in modern prosthetic fabrication. Among the existing studies, the focus has mainly been on user experiences and improved functionality of the AM-fabricated prosthetic parts using commercial materials [ 19 , 20 , 21 ].…”