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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Flexible Flatfoot

Intervention / Treatment
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* Device: Plantar orthoses


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Functional plantar orthoses<br>Functional plantar orthoses in polypropylene with Medial Heel Skive technique | Device: Plantar orthoses<br> <br> |
| Placebo Comparator: Placebo plantar orthoses<br>Plantar orthoses made in Ethil Vinyl Acetate (22º Shore) without correction of the pronation | Device: Plantar orthoses<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| X-ray measurements of the angles: talus-calcaneus, talus-navicular and talus-first metatarsal angle. | 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. | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Flatfoot, orthoses, children