Abstract
Background. Partial or nonweight bearing is a useful treatment prescribed by medical professionals (e.g., orthopedists, podiatrists) for patients rehabilitating from lower extremity injuries However, there is significant variability in patient conformance with the commonly used, but very imprecise “weight scale method.” Furthermore, the few commercially available load monitoring devices are rarely used because of their high cost. Method of Approach. As a simple and inexpensive alternative to current load monitoring methods and commercial products, a new medical device called a snap dome weight bearing indicator (WBI) has been developed to gently warn a patient when they have exceeded a limited percentage of their body weight on the recovering leg or foot. When installed in a patient’s shoe or medical appliance, the device does so by utilizing the reversible buckling phenomena of a snap dome to provide a tactile and audible feedback when the prescribed weight has been exceeded. To demonstrate the feasibility of this new device, the performance of (1) the snap dome by itself and (2) several WBI designs developed were tested. The most useful of the new designs include one incorporating a heel cup for loose fitting medical appliances and a podiatric off-loading indicator (POLI). In addition, a pilot study and manufacturing cost analysis of the POLI device were performed to investigate patient usability and affordability issues. Results. The particular four-leg snap domes used in device prototypes performed quite well with regards to buckling load consistency between domes, the linearity of buckling load by stacking domes in a parallel arrangement, and buckling load repeatability of a single dome. The performance of each WBI prototype was tested with regards to load transfer, tactile, and audible feedback to the patient, patient comfort, and ease of installation. Prototype performance was generally very good or excellent except for the POLI device, which does not provide sufficient tactile or audible feedback for many patients. A costing analysis of the POLI device suggests that it can be manufactured in the U.S. for around one dollar. Conclusions. The generally positive results from performance testing of commercially available snap domes and WBI prototypes suggest that this new medical device will indeed be an inexpensive, yet effective conformance tool for orthopedists and podiatrists to use in prescribing partial or no weight bearing for a patient.
Published Version
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