Evidence-based Customized Ankle-Foot Orthosis with Energy Storage

Abstract

Purpose: Three-dimensional printed ankle-foot orthoses (AFO) have been used in stroke patients recently, but there was little evidence of gait improvement. Here, we designed a novel customized AFO with energy storage, named Energy-Storage 3D Printed Ankle-Foot Orthosis (ESP-AFO), and investigated its effects on gait improvement in stroke patients. Methods: 12 stroke survivors were recruited (9 females/3 males, age: 55.58 ± 5.9 y/o). Participants were instructed to walk (1) bare foot (BF), with (2) anterior AFO (AAFO), and with (3) ESP-AFO, respectively. Gait analysis by the motion capture system was performed bilaterally (SL: Sound limb; AL: Affected limb). Participant satisfaction and fatigue were also compared. Results: We found that the ESP-AFO significantly increased bilateral gait velocity (SL: ESP-AFO 52.62 ± 19.18 cm/s, BF 47.61 ± 22.78 cm/s; AL: ESP-AFO 52.78 ± 19.57 cm/s, BF 47.31 ± 23.27 cm/s), stride length (SL: ESP-AFO 78.96 ± 19.16 cm, BF 74.89 ± 21.92 cm; AL: ESP-AFO 79.06 ± 17.82 cm, BF 74.08 ± 21.31 cm). ESP-AFO reversed drop-foot in swing phase and created a higher ankle moment at terminal stance. Patients also reported more satisfaction with the ESP-AFO (total satisfaction: ESP-AFO 4.3 ± 0.47, AAFO 3.3 ± 0.62). Conclusion: We demonstrated that the novel custom-made ESP-AFO improved the gait performance with better satisfaction than traditional AFOs did. (Registry number of clinical trial: A-BR-106-005)