Effects of a microprocessor-controlled ankle-foot unit on energy expenditure, quality of life, and postural stability in persons with transtibial amputation: An unblinded, randomized, controlled, cross-over study.

BACKGROUND: Microprocessor-controlled prostheses are designed to improve mobility and quality of life through better balance and energy restoration in persons with transtibial amputation. Quasi-active microprocessor-controlled ankles (MPA) adapt to variable terrain by ankle angle adjustment. OBJECTIVES: To compare energy expenditure, balance, quality of life, and satisfaction of Proprio-foot® (a quasi-active MPA model) with standard prescribed ankle prosthesis (prescribed ankle-foot units [PA]) (standard energy storage and return prosthesis). STUDY DESIGN: Multicenter, unblinded, randomized, controlled, cross-over study. METHODS: Energy expenditure (primary outcome) was assessed by oxygen uptake (VO2) measured at the maximum level reached with the 2 prostheses during treadmill walking at progressively increasing incline and speed. Balance was assessed by stabilometry in different static positions. Quality of life and satisfaction were assessed by "Short Form 36" questionnaire (0-100) and by Evaluation de la Satisfaction envers une Aide Technique (0-5) questionnaires after wearing each of the 2 prostheses for 34 days. RESULTS: Forty-five patients tested the 2 prostheses. No statistical difference in VO2 was observed. Significant improvement of balance was observed both during standing on an incline or decline with MPA and PA (p < 0.01). Short Form 36 questionnaire physical scores and Short Form 36 questionnaire mental scores were 68.5 ± 19.5 vs. 62.1 ± 19.6 (p < 0.01) and 72.0 ± 20.8 vs. 66.2 ± 20.9 (p < 0.01) in MPA and PA, respectively. Evaluation de la Satisfaction envers une Aide Technique score on the device was not statistically significant between the 2 groups (MPA 4.4 ± 0.5 vs. PA 4.3 ± 0.5, p = 0.360). CONCLUSION: Proprio-foot® improved balance, quality of life, and patient satisfaction despite no reduction or increase in energy expenditure in comparison with standard energy storage and return prosthesis.