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)

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Acknowledgements

We are grateful to Professor Chung-Yi Lee and Wan-Ni Chen for providing statistical consulting services from the Biostatistics Consulting Center, National Cheng Kung University Hospital.

Funding

This study was supported by the Ministry of Science and Technology of Taiwan (Grant No.: MOST 107-2218-E-006-010-.) and by the Medical Device Innovation Center (MDIC), National Cheng Kung University (NCKU) from the Featured Areas Research Center Program within the framework of the Higher Education Sprout Project by the Ministry of Education (MoE) in Taiwan.

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Correspondence to Fong-Chin Su.

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Lin, CC., Yeh, CH., Tsai, YC. et al. Evidence-based Customized Ankle-Foot Orthosis with Energy Storage. J. Med. Biol. Eng. 41, 126–136 (2021). https://doi.org/10.1007/s40846-020-00593-w

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Keywords

  • 3D printed ankle-foot orthosis
  • Energy storage
  • AAFO
  • Stroke
  • Gait analysis