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

Not Applicable

Completed

• Conditions: Flexible Flatfoot
• Interventions: Device: Plantar orthoses

• Registration Number: NCT02633566
• Lead Sponsor: Fresno, Raquel Lopez, M.D.

Brief 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.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2013-04
• Study Completion: 2014-05
• Status Verified: 2015-12
• Study First Submitted: 2015-12-10
• Study First Submitted QC: 2015-12-14
• Last Update Submitted: 2015-12-14
• Study First Posted: 2015-12-17
• Last Update Posted: 2015-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• Flexible flatfoot

Exclusion Criteria

• Congenital Vertical talus
• Tarsal coalition
• Neuromuscular disease
• Ligamentous laxity
• Previous history of surgery on lower limb
• Previous orthotic treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo plantar orthoses	Plantar orthoses	Plantar orthoses made in Ethil Vinyl Acetate (22º Shore) without correction of the pronation
Functional plantar orthoses	Plantar orthoses	Functional plantar orthoses in polypropylene with Medial Heel Skive technique

Primary Outcome Measures

Name	Time	Method
X-ray measurements of the angles: talus-calcaneus, talus-navicular and talus-first metatarsal angle.	One year	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 sataistical test.