Efficacy of Personalized Foot Orthoses in Children with Flexible Flat Foot: Protocol for a Randomized Controlled Trial

Abstract

Pediatric flat foot (PFF) is a very frequent entity and a common concern for parents and health professionals. There is no established definition, diagnostic method, or clear treatment approach. There are multiple conservative and surgical treatments, the implantation of foot orthoses (FO) being the most used treatment. The evidence supporting FO is very thin. It is not clearly known what the effect of these is, nor when it is convenient to recommend them. The main objective of this protocol is to design a randomized controlled trial to determine if personalized FO, together with a specific exercise regimen, produce the same or better results regarding the signs and symptoms of PFF, compared to only specific exercises. In order to respond to the stated objectives, we have proposed a randomized controlled clinical trial, in which we intend to evaluate the efficacy of FO together with strengthening exercises, compared to a control group in which placebos will be implanted as FO treatment along with the same exercises as the experimental group. For this, four measurements will be taken throughout 18 months (pre-treatment, two during treatment and finally another post-treatment measurement). The combination of FO plus exercise is expected to improve the signs and symptoms (if present) of PFF compared to exercise alone and the placebo FO group. In addition, it is expected that in both conditions the biomechanics of the foot will improve compared to the initial measurements.