Mobility and Quality of Life in Unilateral Transtibial Prosthetic Users with Unmet Mobility Needs: A Multicenter Randomized Comparison of a Novel Prosthetic Foot and ESAR Feet

Background: Prosthetic foot design continues to evolve to better address the functional needs and daily challenges of individuals with lower limb loss. Energy-Storing and Returning (ESAR) feet are widely prescribed for individuals with transtibial amputation; however, many users continue to report limitations. A novel prosthetic foot incorporates a pivot mechanism intended to enhance ankle motion and support a more natural gait. Objectives: We aimed to compare mobility, comfort, quality of life, and user satisfaction between a novel prosthetic foot and commonly prescribed ESAR feet in adults with unilateral transtibial amputation with unmet mobility needs. Methods: A prospective, multicenter, randomized cross-over trial was conducted across seven rehabilitation centers in France. Thirty adults with unilateral transtibial amputation, all regular ESAR users, were randomized to one of two sequences: their prescribed ESAR foot followed by the novel foot, or the reverse. Each device was worn for four weeks. The primary outcome was mobility assessed using the Prosthetic Limb Users Survey of Mobility (PLUS-M) T-score. Data were analyzed using linear mixed-effects models. Secondary outcomes included comfort, quality of life, satisfaction, falls, participant preference, and adverse events. Results: All participants completed the study. Mobility scores were significantly higher with the novel foot compared to the prescribed ESAR foot (least squares mean PLUS-M/FC-12 T-score: 60.2 vs. 52.3; difference 7.9; p < 0.001). Participants reported greater comfort, improved quality of life (LS mean difference 5.7; p = 0.001), and higher satisfaction with the novel prosthesis (LS mean difference 0.4; p = 0.002). No falls occurred with the novel foot, compared with three falls with the ESAR foot. Most participants (96.7%) preferred the novel foot. No device-related adverse events were reported. Conclusions: In adults with unilateral transtibial amputation, the novel pivot foot was associated with improvements in mobility, comfort, quality of life, and satisfaction compared to commonly prescribed ESAR feet, supporting its potential benefits for individuals with higher mobility demands.