User preference and patient benefits of a novel energy storing and return foot: A randomized, cross-over clinical trial.

Abstract

Background: Energy storing and return (ESAR) prosthetic feet often provide high energy return at the cost of increased foot height, compromised appearance, and reduced flexibility. An ESAR foot, Ottobock Evanto, with a novel compact design has been introduced (novel foot).

Objective: To characterize user preference and benefits of a novel foot compared with the subject's previously worn (everyday foot) and comparator foot, Össur Pro-Flex XC.Study Design:Multicenter, randomized, nonblinded, cross-over trial (ClinicalTrials.gov, NCT05628064).

Methods: Transtibial amputees using ESAR feet were eligible. Outcome measures included perceived mobility, the extent of meeting amputees' needs, pain intensity, EuroQol 5-Dimension 5-Level, Activities-specific Balance Confidence, pain interference, foot preference, and walking experience. The first 3 measures with the novel foot vs. the everyday and comparator feet were used for primary objectives.

Results: Data from 20 participants were analyzed. For all primary outcomes, improved scores while wearing the novel foot were obtained. The change in perceived mobility vs. the everyday foot score was highly significant (P = 0.0007). The novel foot was the most preferred foot overall (55% participants) and for many activities, e.g., walking on inclines (85%) and over uneven terrain (70%). Participants confirmed that the novel foot made walking up slopes easier (95%), standing more flexible (85%), and heel strike more comfortable (85%) vs. their everyday feet.

Conclusions: The novel foot offers advantages compared with the tested feet, including making walking on uneven terrain and slopes easier and more comfortable heel strike. Activities in which the novel foot would perform worse than the other feet have not been reported.