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.