Effectiveness of a New Microprocessor-Controlled Knee–Ankle–Foot System for Transfemoral Amputees: A Randomized Controlled Trial

Abstract

Background: Advances in prosthetic technology, especially microprocessor-controlled knees (MPKs), have helped enhance gait symmetry and reduce fall risks for individuals who have undergone transfemoral amputation. However, challenges remain in walking in constrained situations due to the limitations of passive prosthetic feet, lacking ankle mobility. This study investigates the benefits of SYNSYS®, a new microprocessor-controlled knee–ankle–foot system (MPKA_NEW), designed to synergize knee and ankle movements. Methods: A randomized crossover trial was conducted on 12 male participants who had undergone transfemoral amputation who tested both the MPKA_NEW and their usual MPK prosthesis. Biomechanical parameters were evaluated using quantitative gait analysis in various walking conditions. Participants also completed self-reported questionnaires on their quality of life, locomotor abilities, and prosthesis satisfaction. Results: The MPKA_NEW showed a significant reduction in the risk of slipping and tripping compared to standard MPK prostheses, as evidenced by increased flat-foot time and minimum toe clearance during gait analysis. The MPKA_NEW also improved physical component scores in quality-of-life assessments (Short-Form 36 General Health Questionnaire), suggesting enhanced stability and reduced cognitive load during walking. Conclusions: The MPKA_NEW offers significant improvements in gait safety and quality of life for people who have undergone TFA, particularly in challenging conditions. Further studies are needed to assess the long-term benefits and adaptability across diverse amputee populations.