A Randomized Controlled Trial of Two Types of In-Shoe Orthoses in Children with Flexible Excess Pronation of the Feet

Abstract

Background: Orthoses for children with flexible excess pronation are estimated to cost Australian parents millions of dollars per year; however, there is no high-level evidence that orthoses improve function or reduce pain. Methods: A randomized parallel, single-blinded, controlled trial of custom-made and ready-made orthoses was conducted in children between the ages of 7 and 11 years with bilateral flexible excess pronation. The diagnosis was based on calcaneal eversion and navicular drop. Outcomes included gross motor proficiency, self-perception, exercise efficiency, and pain. Measurements were taken at baseline, and at 3 and 12 months. Of the 178 children who participated at baseline, 160 continued to the end of the trial. Results: After randomization, baseline characteristics were similar between the three treatment groups (custom-made, ready-made, and control). Statistical modeling demonstrated that although for most outcome measures there were statistically significant trends over time, none of the group comparisons were statistically significant. A sub-group analysis of those presenting with pain found no significant differences at 3 or 12 months. Conclusions: This study found no evidence to justify the use of in-shoe orthoses in the management of flexible excess foot pronation in children.