journal article·2022-04-30Open access

The Functionality Verification through Pilot Human Subject Testing of MyFlex-δ: An ESR Foot Prosthesis with Spherical Ankle Joint

Johnnidel Tabucol, Vera Geertruida Maria Kooiman, Marco Leopaldi, Tommaso Maria Brugo, Ruud Adrianus Leijendekkers, Gregorio Tagliabue, Vishal Raveendranathan, Eleonora Sotgiu, Pietro Benincasa, Magnus Oddsson, Nico Verdonschot, Raffaella Carloni, Andrea Zucchelli

Applied Sciences· Volume 12· Issue 9

Abstract

Most biomechanical research has focused on level-ground walking giving less attention to other conditions. As a result, most lower limb prosthesis studies have focused on sagittal plane movements. In this paper, an ESR foot is presented, of which five different stiffnesses were optimized for as many weight categories of users. It is characterized by a spherical ankle joint, with which, combined with the elastic elements, the authors wanted to create a prosthesis that gives the desired stiffness in the sagittal plane but at the same time, gives flexibility in the other planes to allow the adaptation of the foot prosthesis to the ground conditions. The ESR foot was preliminarily tested by participants with transfemoral amputation. After a brief familiarization with the device, each participant was asked to wear markers and to walk on a sensorized treadmill to measure their kinematics and kinetics. Then, each participant was asked to leave feedback via an evaluation questionnaire. The measurements and feedback allowed us to evaluate the performance of the prosthesis quantitatively and qualitatively. Although there were no significant improvements on the symmetry of the gait, due also to very limited familiarization time, the participants perceived an improvement brought by the spherical ankle joint.
Source: crossref · Quality: baseline

Research context

OpenAlex topics: Prosthetics and Rehabilitation Robotics · Muscle activation and electromyography studies · Advanced Sensor and Energy Harvesting Materials

SciVX discovery tags are terminology-based. OpenAlex topics are source-provided classifications.

Affiliations

Department of Industrial Engineering, University of Bologna, 40131 Bologna, Italy

Interdepartmental Centre for Industrial Research in Advanced Mechanical Engineering Applications and Materials Technology, University of Bologna, 40131 Bologna, Italy

Bernoulli Institute for Mathematics, Computer Science and Artificial Intelligence, Faculty of Science and Engineering, University of Groningen, 9747 AG Groningen, The Netherlands

Orthopedic Research Laboratory, Radboud University Medical Center, 6525 GA Nijmegen, The Netherlands

Department of Rehabilitation, Donders Institute for Brain, Cognition and Behavior, Radboud University Medical Center, 6525 GA Nijmegen, The Netherlands

IQ Healthcare, Radboud Institute for Health Sciences, Radboud University Medical Center, 6525 GA Nijmegen, The Netherlands

Research and Development, Össur, 110 Reykjavík, Iceland

Department of Biomechanical Engineering, University of Twente, 7522 NB Enschede, The Netherlands

Funding

European Commission’s Horizon 2020 Programme

References (100+)

Show source-provided references
1. Shepherd, M.K., and Rouse, E.J. (June, January 29). Design of a quasi-passive ankle-foot prosthesis with biomimetic, variable stiffness. Proceedings of the 2017 IEEE International Conference on Robotics and Automation (ICRA), Singapore.10.1109/ICRA.2017.7989788 ↗
2. The VSPA foot: A quasi-passive ankle-foot prosthesis with continuously variable stiffness10.1109/TNSRE.2017.2750113 ↗
3. Design and validation of a semi-active variable stiffness foot prosthesis10.1109/TNSRE.2018.2877962 ↗
4. Tryggvason, H., Starker, F., Lecomte, C., and Jonsdottir, F. (2020). Use of dynamic FEA for design modification and energy analysis of a variable stiffness prosthetic foot. Appl. Sci., 10.10.3390/app10020650 ↗
5. Speed Adaptable Prosthetic Foot: Concept Description, Prototyping and Initial User Testing10.1109/TNSRE.2020.3036329 ↗
6. Variable stiffness prosthetic foot based on rheology properties of shear thickening fluid10.1088/1361-665X/ab9547 ↗
7. Variable stiffness foot design and validation10.1016/j.jbiomech.2021.110440 ↗
8. Au, S.K., Weber, J., and Herr, H. (2007, January 13–15). Biomechanical design of a powered ankle-foot prosthesis. Proceedings of the 2007 IEEE 10th International Conference on Rehabilitation Robotics, Noordwijk, The Netherlands.10.1109/ICORR.2007.4428441 ↗
9. Au, S.K., Herr, H., Weber, J., and Martinez-Villalpando, E.C. (2007, January 23–26). Powered ankle-foot prosthesis for the improvement of amputee ambulation. Proceedings of the 2007 29th Annual International Conference of the IEEE Engineering in Medicine and Biology Society, Lyon, France.10.1109/IEMBS.2007.4352965 ↗
10. Powered ankle-foot prosthesis to assist level-ground and stair-descent gaits10.1016/j.neunet.2008.03.006 ↗
11. Powered ankle-foot prosthesis10.1109/MRA.2008.927697 ↗
12. Powered ankle–foot prosthesis improves walking metabolic economy10.1109/TRO.2008.2008747 ↗
13. Control of a powered ankle–foot prosthesis based on a neuromuscular model10.1109/TNSRE.2009.2039620 ↗
14. Bionic ankle–foot prosthesis normalizes walking gait for persons with leg amputation10.1098/rspb.2011.1194 ↗
15. Effects of a powered ankle-foot prosthesis on kinetic loading of the unaffected leg during level-ground walking10.1186/1743-0003-10-49 ↗
16. Design and development of ankle-foot prosthesis with delayed release of plantarflexion10.1682/JRRD.2011.06.0107 ↗
17. Robotic transtibial prosthesis with biomechanical energy regeneration10.1108/01439910910980169 ↗
18. An active foot-ankle prosthesis with biomechanical energy regeneration10.1115/1.4001139 ↗
19. Bellman, R.D., Holgate, M.A., and Sugar, T.G. (2008, January 19–22). SPARKy 3: Design of an active robotic ankle prosthesis with two actuated degrees of freedom using regenerative kinetics. Proceedings of the 2008 2nd IEEE RAS & EMBS International Conference on Biomedical Robotics and Biomechatronics, Scottsdale, AZ, USA.10.1109/BIOROB.2008.4762887 ↗
20. Design and control of a powered transfemoral prosthesis10.1177/0278364907084588 ↗
21. Sup, F., Varol, H.A., Mitchell, J., Withrow, T., and Goldfarb, M. (2008, January 19–22). Design and control of an active electrical knee and ankle prosthesis. Proceedings of the 2008 2nd IEEE RAS & EMBS International Conference on Biomedical Robotics and Biomechatronics, Scottsdale, AZ, USA.10.1109/BIOROB.2008.4762811 ↗
22. Preliminary evaluations of a self-contained anthropomorphic transfemoral prosthesis10.1109/TMECH.2009.2032688 ↗
23. Zhu, J., Wang, Q., and Wang, L. (2010, January 6–9). PANTOE 1: Biomechanical design of powered ankle-foot prosthesis with compliant joints and segmented foot. Proceedings of the 2010 IEEE/ASME International Conference on Advanced Intelligent Mechatronics, Montreal, QC, Canada.10.1109/AIM.2010.5695879 ↗
24. On the design of a powered transtibial prosthesis with stiffness adaptable ankle and toe joints10.1109/TIE.2013.2293691 ↗
25. Zhu, J., Wang, Q., Li, X., Sun, W., She, H., and Huang, Q. (2015, January 6–9). Importance of series elasticity in a powered transtibial prosthesis with ankle and toe joints. Proceedings of the 2015 IEEE International Conference on Robotics and Biomimetics (ROBIO), Zhuhai, China.10.1109/ROBIO.2015.7418824 ↗
26. PANTOE II: Improved Version of a Powered Transtibial Prosthesis with Ankle and Toe Joints
27. Design of a powered ankle-foot prosthesis with an adjustable stiffness toe joint10.1080/01691864.2020.1750479 ↗
28. Cherelle, P., Matthys, A., Grosu, V., Vanderborght, B., and Lefeber, D. (2012, January 24–27). The amp-foot 2.0: Mimicking intact ankle behavior with a powered transtibial prosthesis. Proceedings of the 2012 4th IEEE RAS & EMBS International Conference on Biomedical Robotics and Biomechatronics (BioRob), Rome, Italy,.10.1109/BioRob.2012.6290783 ↗
29. Grosu, S., Cherelle, P., Verheul, C., Vanderborght, B., and Lefeber, D. (2013, January 1–4). AMP-Foot 2.0 prosthesis dynamic behavior, preliminary computational multibody dynamics simulation results. Proceedings of the ECCOMAS Thematic Conference on Multi-Body Dynamics, Zagreb, Croatia.
30. Madusanka, D., Wijayasingha, L., Sanjeevan, K., Ahamed, M., Edirisooriya, J., and Gopura, R. (2014, January 22–24). A 3DOF transtibial robotic prosthetic limb. Proceedings of the 7th International Conference on Information and Automation for Sustainability, Colombo, Sri Lanka.10.1109/ICIAFS.2014.7069617 ↗
31. Conceptual design of a powered ankle-foot prosthesis for walking with inversion and eversion10.1016/j.protcy.2014.08.030 ↗
32. Design and control of a pneumatically actuated transtibial prosthesis10.1016/S1672-6529(14)60114-1 ↗
33. Walk the walk: A lightweight active transtibial prosthesis10.1109/MRA.2015.2408791 ↗
34. Combining push-off power and nonlinear damping behaviors for a lightweight motor-driven transtibial prosthesis10.1109/TMECH.2017.2766205 ↗
35. Gao, F., Liu, Y., and Liao, W.H. (201, January 3–7). A new powered ankle-foot prosthesis with compact parallel spring mechanism. Proceedings of the 2016 IEEE International Conference on Robotics and Biomimetics (ROBIO), Qingdao, China.10.1109/ROBIO.2016.7866367 ↗
36. Design of powered ankle-foot prosthesis with nonlinear parallel spring mechanism10.1115/1.4039385 ↗
37. Rad, N.F., Yousefi-Koma, A., Tajdari, F., and Ayati, M. (2016, January 26–28). Design of a novel three degrees of freedom ankle prosthesis inspired by human anatomy. Proceedings of the 2016 4th International Conference on Robotics and Mechatronics (ICROM), Tehran, Iran.10.1109/ICRoM.2016.7886776 ↗
38. Biologically inspired design and development of a variable stiffness powered ankle-foot prosthesis10.1115/1.4043603 ↗
39. Design and Control of a Compliant Electro-Hydrostatic-Powered Ankle Prosthesis
40. A compact, lightweight robotic ankle-foot prosthesis: Featuring a powered polycentric design10.1109/MRA.2019.2955740 ↗
41. Gabert, L., Tran, M., and Lenzi, T. (2021, January 1–5). Design of an underactuated powered ankle and toe prosthesis. Proceedings of the 2021 43rd Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC), Virtual, Mexico.10.1109/EMBC46164.2021.9629842 ↗
42. Design and preliminary results of a reaction force series elastic actuator for bionic knee and ankle prostheses10.1109/TMRB.2021.3098921 ↗
43. Self-Contained 2-DOF Ankle-Foot Prosthesis With Low-Inertia Extremity for Agile Walking on Uneven Terrain10.1109/LRA.2021.3098931 ↗
44. A Review of Commonly Used Prosthetic Feet for Developing Countries: A Call for Research and Development10.4172/2165-7025.1000380 ↗
45. Hansen, A., and Starker, F. (2017). Prosthetic foot principles and their influence on gait. Handbook of Human Motion, Springer.10.1007/978-3-319-14418-4_74 ↗
46. Grimmer, M. (2015). Powered Lower Limb Prostheses. [Ph.D. Thesis, Johannes Kepler University Linz].
47. Ficanha, E.M., and Rastgaar, M. (August, January 12). Preliminary design and evaluation of a multi-axis ankle-foot prosthesis. Proceedings of the 5th IEEE RAS/EMBS International Conference on Biomedical Robotics and Biomechatronics, Sao Paolo, Brazil.
48. Evaluation of the subtalar joint during gait using 3-D motion analysis: Does the STJ achieve neutral position?
49. A public dataset of overground and treadmill walking kinematics and kinetics in healthy individuals10.7717/peerj.4640 ↗
50. Video task analysis of turning during activities of daily living10.1016/j.gaitpost.2006.04.003 ↗
51. Kinematic adaptations of the hindfoot, forefoot, and hallux during cross-slope walking10.1016/j.gaitpost.2010.07.004 ↗
52. Gray, H. (2015). Gray’s Anatomy: With Original Illustrations by Henry Carter, Arcturus Publishing Ltd.
53. Sarrafian, S.K. (1993). Biomechanics of the subtalar joint complex. Clin. Orthop. Relat. Res., 17–26.10.1097/00003086-199305000-00003 ↗
54. The mechanics of the foot: I. The joints
55. Biomechanics of the ankle10.1016/j.mporth.2016.04.015 ↗
56. Biomechanics of the ankle joint and clinical outcomes of total ankle replacement10.1016/j.jmbbm.2008.01.005 ↗
57. Merlette, J.B. (2001). Foot Prosthesis. (6,261,324), U.S. Patent.
58. Smith, N., Rush, D., and Williams, N. (2005). Multi-Axial Prosthetic Foot. (10/663,514), U.S. Patent.
59. Clausen, A.V., Ragnarsdottir, H.G., Lecomte, C., and Thorhallsdottir, H. (2008). Foot Prosthesis with Resilient Multi-Axial Ankle. (7,347,877), U.S. Patent.
60. Lecomte, C.G., Thorhallsdottir, H., Ragnarsdottir, H.G., and Clausen, A.V. (2010). Foot Prosthesis with Resilient Multi-Axial Ankle. (7,846,213), U.S. Patent.
61. Lecomte, C.G., Thorhallsdottir, H., Ragnarsdottir, H.G., and Clausen, A.V. (2011). Foot Prosthesis with Resilient Multi-Axial Ankle. (8,025,699), U.S. Patent.
62. Harrison, N.F. (1911). Ankle-Joint. (1,001,641), U.S. Patent.
63. Kaiser, W.F. (1939). Artificial Ankle Joint. (2,183,076), U.S. Patent.
64. Georg, G. (1952). Artificial Foot with Ankle-joint. (2,620,485), U.S. Patent.
65. Carl, W. (1956). Ankle Joint for Artificial Limbs. (2,731,645), U.S. Patent.
66. Cornelius, C.J. (1996). Prosthetic Ankle Joint for Pivotally Connecting a Residual Limb to a Prosthetic Foot. (5,571,212), U.S. Patent.
67. Farneth, C.S. (1965). Ankle Joint for Artificial Limb. (3,196,463), U.S. Patent.
68. Mccoy, A.J. (1995). Articulated Ankle Joint with Inner and Outer Races for Universal Movement. (5,405,411), U.S. Patent.
69. Christensen, R.J. (2010). Multi-Axial Prosthetic Ankle. (7,794,506), U.S. Patent.
70. Scientific methods to determine functional performance of prosthetic ankle-foot systems10.1097/00008526-200510001-00008 ↗
71. Comprehensive analysis of energy storing prosthetic feet: Flex Foot and Seattle Foot Versus Standard SACH foot10.1016/S0003-9993(23)00022-9 ↗
72. Comprehensive analysis of dynamic elastic response feet: Seattle Ankle/Lite Foot versus SACH foot10.1016/0003-9993(93)90013-Z ↗
73. Knox, E.H. (1996). The Role of Prosthetic Feet in Walking, Northwestern University.
74. Tabucol, J., Brugo, T.M., Povolo, M., Leopaldi, M., Oddsson, M., Carloni, R., and Zucchelli, A. (2022). Structural FEA-Based Design and Functionality Verification Methodology of Energy-Storing-and-Releasing Prosthetic Feet. Appl. Sci., 12.10.3390/app12010097 ↗
75. Energy storage and release of prosthetic feet Part 2: Subjective ratings of 2 energy storing and 2 conventional feet, user choice of foot and deciding factor10.3109/03093649709164527 ↗
76. Erratum: Gait analysis and energy consumption of below-knee amputees wearing three different prosthetic feet (Gait and Posture (2000) 12 (162–168))10.1016/j.gaitpost.2003.08.007 ↗
77. Perception of walking difficulty by below-knee amputees using a conventional foot versus the flex-foot
78. Subjective and objective analysis of an energy-storing prosthetic foot10.1097/00008526-198907000-00006 ↗
79. Functional evaluation by gait analysis of various ankle-foot assemblies used by below-knee amputees10.3109/03093649209164337 ↗
80. With a Spring in one’s step
81. Practical benefits of Flex-Foot in below-knee amputees10.1097/00008526-199100340-00011 ↗
82. The assessment and description of amputee activity10.3109/03093648109146225 ↗
83. The amputee mobility predictor: An instrument to assess determinants of the lower-limb amputee’s ability to ambulate10.1053/apmr.2002.32309 ↗
84. Gait analysis and energy cost of below-knee amputees wearing six different prosthetic feet10.1097/00008526-199212000-00001 ↗
85. Bioenergetic comparison of a new energy-storing foot and SACH foot in traumatic below-knee vascular amputations10.1016/S0003-9993(95)80040-9 ↗
86. Optimisation of the prescription for trans-tibial (TT) amputees10.3109/03093649709164550 ↗
87. Analysis of gait following below-knee amputation: A comparison of the SACH and single-axis foot
88. Below-knee amputation: A comparison of the effect of the SACH foot and single axis foot on electromyographic patterns during locomotion10.3109/03093648609103074 ↗
89. A comparison of the SACH and single axis foot in the gait of unilateral below-knee amputees10.3109/03093648309146713 ↗
90. Biomechanical analysis of the influence of prosthetic feet on below-knee amputee walking10.1097/00002060-199106000-00006 ↗
91. Biomechanical evaluation of SACH and uniaxial feet10.3109/03093648409146077 ↗
92. Physiological measurements of walking and running in people with transtibial amputations with 3 different prostheses10.2519/jospt.1999.29.9.526 ↗
93. Gait comparisons for below-knee amputees using a Flex-Foot versus a conventional prosthetic foot10.1097/00008526-199100340-00008 ↗
94. Mechanical gait analysis of transfemoral amputees: SACH foot versus the Flex-Foot10.1097/00008526-199700940-00004 ↗
95. Comparative biomechanical analysis of energy-storing prosthetic feet
96. Comparison of energy cost and gait efficiency during ambulation in below-knee amputees using different prosthetic feet
97. Prosthetic weight acceptance mechanics in transtibial amputees wearing the Single Axis, Seattle Lite, and Flex Foot10.1109/86.650279 ↗
98. Efficiency of dynamic elastic response prosthetic feet
99. Energy storage and release of prosthetic feet Part 1: Biomechanical analysis related to user benefits10.3109/03093649709164526 ↗
100. Influence of prosthetic foot design on sound limb loading in adults with unilateral below-knee amputations10.1016/0003-9993(94)90146-5 ↗