Objective: Custom foot orthoses (CFOs) are typically used for the prevention and cure of lower extremity injuries (LEIs). Typically, CFOs are designed and prescribed based on iterative loops including: (1) follow-up loops between the patient and the physician, and (2) design feedback loops between the physician and the fabricator. The current prescription methodology has some deficiencies, i.e. excessive time to satisfactory treatment, and low repeatability in custom fabrication because of missing alignment, soft tissue considerations, and subjective feedback. There are significant opportunities to develop a new CFOs prescription procedure which can improve accuracy prior to the fabrication process by reducing time through minimizing iterations.
Methods: First, a novel "rapid evaluate and adjust device" (READ) prescription methodology is proposed for CFO design by combining the follow-up loops with design feedback loop. To support the idea of the READ prescription method a novel 3D ergonomic measurement system (3DEMS) is developed. The 3DEMS is designed for the following key targets to: (1) improve the communication between the patient/physician and the fabricator, (2) reduce time to satisfactory treatment, (3) improve repeatability by considering the alignment and the soft tissue deformations, (4) archive digitally with minimal data, (5) reduce the system complexity, and (6) validate with plantar pressure measurements (i.e. Novel Pedar®). The design process of the 3DEMS involved the following steps: (1) 3D data collection at the desired loading, (2) nested optimization to determine optimal segment design, and (3) system fabrication considering alignment and feedback control.
Results: The results show that the READ prescription method with 3DEMS can be used to recreate the medial longitudinal arch for a range of arch height indices (AHI) by using a minimal number of parameters i.e. 6 parameters, and significant increases in mean peak pressure are observed between optimized and barefoot or flat segments.
Conclusion: This study establishes that the proposed READ prescription method with the 3DEMS may be used for CFOs prescription due to better communication between individuals in the follow-up and design loops, less time for satisfactory treatment, improved repeatability, archivable data, and low system complexity.
Significance: The developed system may be used as measurement systems for CFOs, and in the future the proposed 3DEMS may prove highly important for the measurement of CFOs for flat feet.
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