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Introduction: Simulations based on computational musculoskeletal models are powerful tools for evaluating the effects of potential biomechanical interventions, such as implementing a novel prosthesis. However, the utility of simulations to evaluate the effects of varied prosthesis design parameters on gait mechanics has not been fully realized due to the lack of a readily-available limb loss-specific gait model and methods for efficiently modeling the energy storage and return dynamics of passive foot prostheses. The purpose of this study was to develop and validate a forward simulation-capable gait model with lower-limb loss and a semi-active variable-stiffness foot (VSF) prosthesis. Methods: A seven-segment 28-DoF gait model was developed and forward kinematics simulations, in which experimentally observed joint kinematics were applied and the resulting contact forces under the prosthesis evolved accordingly, were computed for four subjects with unilateral below-knee amputation walking with a VSF. Results: Model-predicted resultant ground reaction force (GRFR) matched well under trial-specific optimized parameter conditions (mean R²: 0.97, RMSE: 7.7% body weight (BW)) and unoptimized (subject-specific, but not trial-specific) parameter conditions (mean R²: 0.93, RMSE: 12% BW). Simulated anterior-posterior center of pressure demonstrated a mean R² = 0.64 and RMSE = 14% foot length. Simulated kinematics remained consistent with input data (0.23 deg RMSE, R² > 0.99) for all conditions. Conclusions: These methods may be useful for simulating gait among individuals with lower-limb loss and predicting GRFR arising from gait with novel VSF prostheses. Such data are useful to optimize prosthesis design parameters on a user-specific basis. [ABSTRACT FROM AUTHOR]

Introduction: Simulations based on computational musculoskeletal models are powerful tools for evaluating the effects of potential biomechanical interventions, such as implementing a novel prosthesis. However, the utility of simulations to evaluate the effects of varied prosthesis design parameters on gait mechanics has not been fully realized due to the lack of a readily-available limb loss-specific gait model and methods for efficiently modeling the energy storage and return dynamics of passive foot prostheses. The purpose of this study was to develop and validate a forward simulation-capable gait model with lower-limb loss and a semi-active variable-stiffness foot (VSF) prosthesis. Methods: A seven-segment 28-DoF gait model was developed and forward kinematics simulations, in which experimentally observed joint kinematics were applied and the resulting contact forces under the prosthesis evolved accordingly, were computed for four subjects with unilateral below-knee amputation walking with a VSF. Results: Model-predicted resultant ground reaction force (GRFR) matched well under trial-specific optimized parameter conditions (mean R2: 0.97, RMSE: 7.7% body weight (BW)) and unoptimized (subject-specific, but not trial-specific) parameter conditions (mean R2: 0.93, RMSE: 12% BW). Simulated anterior-posterior center of pressure demonstrated a mean R2 = 0.64 and RMSE = 14% foot length. Simulated kinematics remained consistent with input data (0.23 deg RMSE, R2 > 0.99) for all conditions. Conclusions: These methods may be useful for simulating gait among individuals with lower-limb loss and predicting GRFR arising from gait with novel VSF prostheses. Such data are useful to optimize prosthesis design parameters on a user-specific basis. [ABSTRACT FROM AUTHOR]

Passive energy storage and return (ESR) feet are current performance standard in lower limb prostheses. A recently developed semi-active variable-stiffness foot (VSF) prosthesis balances the simplicity of a passive ESR device with the adaptability of a powered design. The purpose of this study was to model and simulate the ESR properties of the VSF prosthesis. The ESR properties of the VSF were modeled as a lumped parameter overhung beam. The overhung length is variable, allowing the model to exhibit variable ESR stiffness. Foot-ground contact was modeled using sphere-to-plane contact models. Contact parameters were optimized to represent the geometry and dynamics of the VSF and its foam base. Static compression tests and gait were simulated. Simulation outcomes were compared to corresponding experimental data. Stiffness of the model matched that of the physical VSF (R2: 0.98, root-mean-squared error (RMSE): 1.37 N/mm). Model-predicted resultant ground reaction force (GRFR) matched well under optimized parameter conditions (R2: 0.98, RMSE: 5.3% body weight,) and unoptimized parameter conditions (R2: 0.90, mean RMSE: 13% body weight). Anterior-posterior center of pressure matched well with R2 > 0.94 and RMSE < 9.5% foot length in all conditions. The ESR properties of the VSF were accurately simulated under benchtop testing and dynamic gait conditions. These methods may be useful for predicting GRFR arising from gait with novel prostheses. Such data are useful to optimize prosthesis design parameters on a user-specific basis. [ABSTRACT FROM AUTHOR]

This paper presents the design and validation of a novel lower limb prosthesis called the variable stiffness foot (VSF), designed to vary its forefoot stiffness in response to user activity. The VSF is designed as a semi-active device that adjusts its stiffness once per stride during swing phases, in order to minimize size, mass, and power consumption. The forefoot keel is designed as an overhung composite beam, whose stiffness is varied by moving a support fulcrum to change the length of the overhang. Stiffness modulation is programmed in response to the gait characteristics detected through foot trajectory reconstruction based on an embedded inertial sensor. The prototype VSF has a mass of only 649 g including the battery, and a build height of 87 mm. Mechanical testing demonstrated a forefoot stiffness range of 10–32 N/mm for the prototype, a threefold range of stiffness variation. The stiffness range can be altered by changing the keel material or geometry. Actuation testing showed that the VSF can make a full-scale stiffness adjustment within three strides, and tracks moderate speed-driven variations within one swing phase. Human subjects testing demonstrated greater energy storage and return with lower stiffness settings. This capability may be useful for the modulating prosthesis energy return to better mimic human ankle function. Subjective feedback indicated clear perception by the subjects of contrasts among the stiffness settings, including interpretation of scenarios for which different settings may be beneficial. Future applications of the VSF include adapting stiffness to optimize stairs, ramps, turns, and standing. [ABSTRACT FROM AUTHOR]

Lower-limb amputees expend more energy to walk than non-amputees and have an elevated risk of secondary disabilities. Insufficient push-off by the prosthetic foot may be a contributing factor. We aimed to systematically study the effect of prosthetic foot mechanics on gait, to gain insight into fundamental prosthetic design principles. We varied a single parameter in isolation, the energy-storing spring in a prototype prosthetic foot, the controlled energy storage and return (CESR) foot, and observed the effect on gait. Subjects walked on the CESR foot with three different springs. We performed parallel studies on amputees and on non-amputees wearing prosthetic simulators. In both groups, spring characteristics similarly affected ankle and body center-of-mass (COM) mechanics and metabolic cost. Softer springs led to greater energy storage, energy return, and prosthetic limb COM push-off work. But metabolic energy expenditure was lowest with a spring of intermediate stiffness, suggesting biomechanical disadvantages to the softest spring despite its greater push-off. Disadvantages of the softest spring may include excessive heel displacements and COM collision losses. We also observed some differences in joint kinetics between amputees and non-amputees walking on the prototype foot. During prosthetic push-off, amputees exhibited reduced energy transfer from the prosthesis to the COM along with increased hip work, perhaps due to greater energy dissipation at the knee. Nevertheless, the results indicate that spring compliance can contribute to push-off, but with biomechanical trade-offs that limit the degree to which greater push-off might improve walking economy. [ABSTRACT FROM PUBLISHER]

(1) Background: Semi-active prosthetic feet can provide adaptation in different circumstances, enabling greater function with less weight and complexity than fully powered prostheses. However, determining how to control semi-active devices is still a challenge. The dynamic mean ankle moment arm (DMAMA) provides a suitable biomechanical metric, as its simplicity matches that of a semi-active device. However, it is unknown how stiffness and locomotion modes affect DMAMA, which is necessary to create closed-loop controllers for semi-active devices. In this work, we develop a method to use only a prosthesis-embedded load sensor to measure DMAMA and classify locomotion modes, with the goal of achieving mode-dependent, closed-loop control of DMAMA using a variable-stiffness prosthesis. We study how stiffness and ground incline affect the DMAMA, and we establish the feasibility of classifying locomotion modes based exclusively on the load sensor. (2) Methods: Human subjects walked on level ground, ramps, and stairs while wearing a variable-stiffness prosthesis in low-, medium-, and high-stiffness settings. We computed DMAMA from sagittal load sensor data and prosthesis geometric measurements. We used linear mixed-effects models to determine subject-independent and subject-dependent sensitivity of DMAMA to incline and stiffness. We also used a machine learning model to classify locomotion modes using only the load sensor. (3) Results: We found a positive linear sensitivity of DMAMA to stiffness on ramps and level ground. Additionally, we found a positive linear sensitivity of DMAMA to ground slope in the low- and medium-stiffness conditions and a negative interaction effect between slope and stiffness. Considerable variability suggests that applications of DMAMA as a control input should look at the running average over several strides. To examine the efficacy of real-time DMAMA-based control systems, we used a machine learning model to classify locomotion modes using only the load sensor. The classifier achieved over 95% accuracy. (4) Conclusions: Based on these findings, DMAMA has potential for use as a closed-loop control input to adapt semi-active prostheses to different locomotion modes. [ABSTRACT FROM AUTHOR]

Introduction: The design and selection of lower-limb prosthetic devices is currently hampered by a shortage of evidence to drive the choice of prosthetic foot parameters. We propose a new approach wherein prostheses could be designed, specified, and provided based on individualized measurements of the benefits provided by candidate feet. In this manuscript, we present a pilot test of this evidence-based and personalized process. Methods: We previously developed a "prosthetic foot emulator," a wearable robotic system that provides users with the physical sensation of trying on different prosthetic feet before definitive fitting. Here we detail preliminary demonstrations of two possible approaches to personalizing foot design: 1) an emulation and test-drive strategy of representative commercial foot models, and 2) a prosthetist-driven tuning procedure to optimize foot parameters. Results: The first experiment demonstrated large and sometimes surprising differences in optimal prosthetic foot parameters across a variety of subjects, walking conditions, and outcome measures. The second experiment demonstrated a quick and effective simple manual tuning procedure for identifying preferred prosthetic foot parameters. Conclusions: Emulator-based approaches could improve individualization of prosthetic foot prescription. The present results motivate future clinical studies of the validity, efficacy, and economics of the approach across larger and more diverse subject populations. Clinical Relevance: Today, emulator technology is being used to accelerate research and development of novel prosthetic and orthotic devices. In the future, after further refinement and validation, this technology could benefit clinical practice by providing a means for rapid test-driving and optimal selection of clinically available prosthetic feet. [ABSTRACT FROM AUTHOR]