Community ambulators with quadriceps insufficiency generally use stance control orthoses (SCO) but show limitations in mobility and daily activities.

This study compared the impact on mobility of SCO and the C-Brace, an innovative microprocessor-controlled orthosis. We used the PLUS-M™ 12-item self-questionnaire and analyzed the effect on quality of life, endurance, balance confidence, participation, satisfaction, and psychosocial adjustment.

This international multicenter randomized crossover trial was conducted in 17 rehabilitation centers from 2 European countries. Community ambulators (ie, ability to walk at 3 km/h) were fitted with the C-Brace and their SCO, in a randomized sequence (2-week transition period). The impact of each orthosis was assessed after 2 months of use in real-life conditions through 6 self-questionnaires and a walking test.

We recruited 38 participants with quadriceps insufficiency (26 males; 12 females; mean age 52.3; SD 12.8). The analysis on the per-protocol (PP) cohort (n = 30) showed that the mobility score (PLUS-M) significantly improved (+21.5%; P <0.001) with the C-Brace. Similarly, the EQ-5D utility significantly improved (+27.2%; P <0.001), as well as the health scores (+21.6%; P = 0.002). The 6MWT score was significantly (P <0.001) improved by 65.9 (SD 84.2) meters (+19.5%). Balance, functional, and user satisfaction scores also showed significant improvement (P <0.001), and the global PIADS score improved by +60.0% on the [-3; +3] scale. Moreover, the C-Brace led to a significant (P = 0.005) decrease in the use of walking aids when walking outdoors. Safety has been reported as the most important satisfaction criterion for participants. In all, 86.7% of participants preferred the C-Brace to their SCO.

Community ambulators with limited knee stability in the stance phase could benefit greatly from this microprocessor-controlled KAFO to improve their outdoor mobility and facilitate completion of daily activities.