NCT02633566

Clinical Trial of the Effect of Functional Orthoses in Children With Flat Feet

Randomized Clinical Trial of the Effect of Functional Orthoses on the Joint Position of the Hindfoot in Children With Flat Feet After a Year of Follow-up

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Fresno, Raquel Lopez, M.D. · Individual
• Sex: All
• Age: 3 Years – 4 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the efficay of functional plantar orthoses on flatfoot in children.

Detailed description

There's a considerable controversy regarding the effectiveness of plantar orthoses in the treatment of flexible flat foot, despite being the most widely used treatment. Several studies tried to investigate the correction of the deformity using plantar orthoses, but there are few studies with a control group of people, not enough to compare the effectiveness of the treatment. A randomized, double-blind, parallel design clinical trial was conducted with two study groups. The sample consisted of 61 children, aged 3 and 4 years old, who were randomly assigned to each study group. One group (intervention group) received treatment with functional plantar orthotics, and the other group (control group) received treatment with placebo-type plantar orthotics, to use as a reference or comparison. Both groups were followed for a one-year period. Before delivering the treatment, all subjects underwent dorsoplantar radiography, repeated at the end of the treatment (after one year). Differences in the talus-calcaneus, tibionavicular and talus-first metatarsal angles were compared, pre and post-treatment of both study groups. Test analysis of covariance (ANCOVA) was performed as a statistical test.

Conditions

• Flexible Flatfoot

Interventions

Type	Name	Description
DEVICE	Plantar orthoses

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-04-01
• Completion: 2014-05-01
• First posted: 2015-12-17
• Last updated: 2015-12-17