Engineering Modeling, Analysis and Optimal Design of Custom Foot Orthotic

This research details a procedure for the systematic design of custom foot orthotics based on simulation models and their validation through experimental and clinical studies. These models may ultimately be able to replace the use of empirical tables for designing custom foot orthotics and enable optimal design thicknesses based on the body weight and activities of end-users. Similarly, they may facilitate effortless simulation of various orthotic and loading conditions, changes in material properties, and foot deformities by simply altering model parameters. Finally, these models and the corresponding results may also form the basis for subsequent design of a new generation of custom foot orthotics. Two studies were carried out, the first involving a methodical approach to development of engineering analysis models using the FEA technique. Subsequently, for model verification and validation purposes, detailed investigations were executed through experimental and clinical studies. The results were within 15% difference for the experimental studies and 26% for the clinical studies, and most of the probability values were greater than α= 0.05 accepting our null hypothesis that the FEA model data versus clinical trial data are not significantly different. The accuracy of the FEA model was further enhanced when the uniform loading condition was replaced with a more realistic pressure distribution of 70% of the weight in the heel and the rest in the front portion of the orthotic. This alteration brought the values down to within 22% difference of the clinical studies, with the P-values once again showed no significant difference between the modified FEA model and the clinical studies for most of the scenarios. The second study dealt with the development of surrogate models from FEA results, which can then be used in lieu of the computationally intensive FEA-based analysis models in the engineering design of CFO. Four techniques were studied, including the second-order polynomial response surface, Kriging, non-parametric regression and neural networking. All four techniques were found to be computationally efficient with an average of over 200% savings in time, and the Kriging technique was found to be the most accurate with an average % difference of below 0.30 for each of the loading conditions (light, medium and heavy). The two studies clearly indicate that engineering modeling, analysis and design using FEA techniques coupled with surrogate modeling methods offer a consistent, accurate and reliable alternative to empirical clinical studies. This powerful alternative simulation-based design framework can be a viable and valuable tool in the custom design of orthotics based on an individual\u27s unique needs and foot characteristics. With these capabilities, the CFO prescriber would be able to design and develop the best-fit CFO with the optimal design characteristics for each individual customer without relying upon extensive and expensive trial and error ad hoc approaches. Such a model could also facilitate the inspection of robustness of resulting designs, as well as enable visual inspection of the impact of even small changes on the overall performance of the CFO. By adding the results from these studies to the CFO community, the prescription process may become more efficient and therefore more affordable and accessible to all populations and groups