Our aim was to develop and evaluate a new antipronation foot orthosis that addressed problems perceived by clinicians and users with existing foot orthoses. Clinicians and users were engaged to develop a user specification for the orthosis, and orthotic geometry and materials were developed using clinical reasoning. The orthotic material properties were tested and the ability of the orthosis to reduce foot pronation evaluated on 27 individuals. Clinicians expressed concern that current prefabricated orthoses often did not offer sufficient support to the foot because of a combination of the shape and materials used, and users concurred but also highlighted issues of durability and hygiene. The geometry of the new orthosis was, therefore, adjusted to enable individual foot size orthoses to be produced. A material was selected that was harder and more durable than materials used in many prefabricated orthoses. When the new orthosis was being worn, maximum rear foot eversion was reduced in both walking (mean reduction -3.8 degrees, p < 0.001) and running (mean reduction -2.5 degrees, p < 0.001). Through a structured process, orthotic design decisions were made that addressed the specific concerns of clinicians and users and the new orthosis was proven to reduce rearfoot pronation.
Keywords: antipronation; biomechanics; eversion; foot; orthotic geometry; orthotic materials; prefabricated orthosis; pronation; rehabilitation; running; walking.