A Reconfigurable and Adjustable Compliance System for the Measurement of Interface Orthotic Properties

Custom foot orthoses (CFOs) have shown treatment effectiveness by providing improved pressure/load redistribution, skeletal support and comfort level. However, the current design methodologies of CFOs have some problems: (1) the plantar surface is captured without considering the soft tissue impedance, (2) the stiffness of the CFOs is limited to rigid, semi-rigid and soft, which ignores the potential effect of local variation of stiffness on the interface pressure/load distribution and subjective evaluations, and (3) the lack of a human-in-the-loop may lead to multiple design-to-deliver iterations. A new prescription methodology of CFOs is required to satisfy the pressure/load distribution, improve comfort level and decrease iterations. Method: A measurement system which provides INterface with Tunable Ergonomic properties using a Reconfigurable Framework with Adjustable Compliant Elements (INTERFACE system) is developed to implement the Rapid Evaluate and Adjust Device (READ) methodology. The geometry and stiffness of the Medial Longitudinal Arch (MLA) support provided by the INTERFACE system can be adjusted via linear actuators and tunable stiffness mechanisms, based on objective interface pressure/load distribution and subjective feedback evaluations. Validation tests were conducted on 13 subjects to measure the plantar pressure/load distribution and record the subjective feedback in different combinations of geometry and stiffness. Results: The interface pressure/load distribution and subjective feedback of the support level indicate the efficacy of the adjustable geometry and stiffness. As the stiffness and geometrical height increased, the plantar loadings increased in the MLA region and decreased in the rear foot. Geometrical fitting can be achieved with the reconfigurable MLA support. The integration of locally adjustable stiffness makes it possible to fine tune the plantar pressure/load and provides the subjects with options of orthotic stiffness. Conclusion: The proposed INTERFACE system can be applied to conduct the measurement of the desired orthotic properties which satisfy the interface pressure/load requirement and the subject's comfort.