Impact of a microprocessor-controlled knee-ankle-foot orthosis in community ambulators with quadriceps insufficiency fitted with an SCO:a randomized crossover trial.

BACKGROUND

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

OBJECTIVES

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.

METHODS

This international multicenter randomized crossover trial was conducted in 17 rehabilitation centers from two 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 six self-questionnaires and a walking test.

RESULTS

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.

CONCLUSIONS

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.