People with lower-limb amputation in low- and middle-income countries (LMICs) lack access to adequate prosthetic devices that would restore their mobility and increase their quality of life. This is largely due to the cost and durability of existing devices. Single-keel energy storage and return (ESR) prosthetic feet have recently been developed using the lower leg trajectory error (LLTE) design framework to provide improved walking benefits at an affordable cost in LMICs. The LLTE framework optimizes the stiffness and geometry of a user’s prosthesis to match a target walking pattern by minimizing the LLTE value, a measure of how closely a prosthetic foot replicates a target walking pattern. However, these low-cost single-keel prostheses do not provide the required durability to fulfill International Standards Organization (ISO) testing, preventing their widespread use and adoption. Here, we developed a multi-keel foot parametric model and extended the LLTE framework to include the multi-keel architecture and durability requirements. Multi-keel designs were shown to provide 76% lower LLTE values, compared with single-keel designs while withstanding ISO fatigue and static tests, validating their durability. Given their single-part 2D extruded geometries, multi-keel feet designed with the extended LLTE framework could be cost-effectively manufactured, providing affordable and durable high-performance prostheses that improve the mobility of LMIC users.
Design and Evaluation of a High-Performance, Low-Cost Prosthetic Foot for Developing Countries
Abstract A novel, high-performance, cosmetic, rugged, appropriately costed, and mass-manufacturable prosthetic foot for use in low-income countries was designed and field tested. This ruggedized foot was created to accommodate the unique economic, environmental, and cultural requirements for users in India. A previous prototype that enabled able-bodied like gait was modified to include a durable cosmetic cover without altering the tuned stiffness of the overall foot. After undergoing mechanical benchtop testing, the foot was distributed to prosthesis users in India to for at least 5 months. Afterward, participants underwent clinical tests to evaluate walking performance, and additional benchtop testing was performed on the field-tested feet to identify changes in performance. The ruggedized foot endured 1 × 106 fatigue cycles without failure and demonstrated the desired stiffness properties. Subjects walked significantly faster (0.14 m/s) with the ruggedized foot compared to the Jaipur foot, and the feet showed no visible sign of damage after months of use. Additionally, the field-tested feet showed little difference in stiffness from a set of unused controls. Anecdotal feedback from the participants indicated that the foot improved their speed and/or walking effort, but may benefit from more degrees-of-freedom about the ankle. The results suggest that the foot fulfills its design requirements; however, further field testing is required with more participants over a longer period to make sure the foot is suitable for use in developing countries.
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- Award ID(s):
- 1653758
- NSF-PAR ID:
- 10407972
- Date Published:
- Journal Name:
- Journal of Medical Devices
- Volume:
- 17
- Issue:
- 1
- ISSN:
- 1932-6181
- Format(s):
- Medium: X
- Sponsoring Org:
- National Science Foundation
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Abstract -
null (Ed.)Abstract While many studies have attempted to characterize the mechanical behavior of passive prosthetic feet to understand their influence on amputee gait, the relationship between mechanical design and biomechanical performance has not yet been fully articulated from a fundamental physics perspective. A novel framework, called lower leg trajectory error (LLTE) framework, presents a means of quantitatively optimizing the constitutive model of prosthetic feet to match a reference kinematic and kinetic dataset. This framework can be used to predict the required stiffness and geometry of a prosthesis to yield a desired biomechanical response. A passive prototype foot with adjustable ankle stiffness was tested by a unilateral transtibial amputee to evaluate this framework. The foot condition with LLTE-optimal ankle stiffness enabled the user to replicate the physiological target dataset within 16% root-mean-square (RMS) error. Specifically, the measured kinematic variables matched the target kinematics within 4% RMS error. Testing a range of ankle stiffness conditions from 1.5 to 24.4 N·m/deg with the same user indicated that conditions with lower LLTE values deviated the least from the target kinematic data. Across all conditions, the framework predicted the horizontal/vertical position, and angular orientation of the lower leg during midstance within 1.0 cm, 0.3 cm, and 1.5 deg, respectively. This initial testing suggests that prosthetic feet designed with low LLTE values could offer benefits to users. The LLTE framework is agnostic to specific foot designs and kinematic/kinetic user targets, and could be used to design and customize prosthetic feet.more » « less
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Abstract The walking pattern and comfort of a person with lower limb amputation are determined by the prosthetic foot’s diverse set of mechanical characteristics. However, most design methodologies are iterative and focus on individual parameters, preventing a holistic design of prosthetic feet for a user’s body size and walking preferences. Here we refined and evaluated the lower leg trajectory error (LLTE) framework, a novel quantitative and predictive design methodology that optimizes the mechanical function of a user’s prosthesis to encourage gait dynamics that match their body size and desired walking pattern. Five people with unilateral below-knee amputation walked over-ground at self-selected speeds using an LLTE-optimized foot made of Nylon 6/6, their daily-use foot, and a standardized commercial energy storage and return (ESR) foot. Using the LLTE feet, target able-bodied kinematics and kinetics were replicated to within 5.2% and 13.9%, respectively, 13.5% closer than with the commercial ESR foot. Additionally, energy return and center of mass propulsion work were 46% and 34% greater compared to the other two prostheses, which could lead to reduced walking effort. Similarly, peak limb loading and flexion moment on the intact leg were reduced by an average of 13.1%, lowering risk of long-term injuries. LLTE-feet were preferred over the commercial ESR foot across all users and preferred over the daily-use feet by two participants. These results suggest that the LLTE framework could be used to design customized, high performance ESR prostheses using low-cost Nylon 6/6 material. More studies with large sample size are warranted for further verification.more » « less
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Abstract Advances in understanding the effects the mechanical characteristics of prosthetic feet on user biomechanics have enabled passive prostheses to improve the walking pattern of people with lower limb amputation. However, there is no consensus on the design methodology and criteria required to maximize specific user outcomes and fully restore their mobility. The Lower Leg Trajectory Error (LLTE) framework is a novel design methodology based on the replication of lower leg dynamics. The LLTE value evaluates how closely a prosthetic foot replicates a target walking pattern. Designing a prosthesis that minimizes the LLTE value, optimizes its mechanical function to enable users to best replicate the target lower leg trajectory. Here, we conducted a systematic sensitivity investigation of LLTE-optimized prostheses. Five people with unilateral transtibial amputation walked overground at self-selected speeds using five prototype energy storage and return feet with varying LLTE values. The prototypes' LLTE values were varied by changing the stiffness of the participant's LLTE-optimized design by 60%, 80%, 120%, and 167%. Users most closely replicated the target able-bodied walking pattern with the LLTE-optimized stiffness, experimentally demonstrating that the predicted optimum was a true optimum. Additionally, the predicted LLTE values were correlated to the user's ability to replicate the target walking pattern, user preferences, and clinical outcomes including roll-over geometries, trunk sway, prosthetic energy return, and peak push-off power. This study further validates the use of the LLTE framework as a predictive and quantitative tool for designing and evaluating prosthetic feet.more » « less
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- Free Publicly Accessible Full Text
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Accepted Manuscript1.0
- Journal Article:
- https://doi.org/10.1115/1.4055967
