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

December 14, 2015 updated by: Raquel Lopez Fresno, Fresno, Raquel Lopez, M.D.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fresno, Raquel Lopez, M.D.

Investigators

  • Study Director: Javier Pascual Huerta, PhD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

December 10, 2015

First Submitted That Met QC Criteria

December 14, 2015

First Posted (Estimate)

December 17, 2015

Study Record Updates

Last Update Posted (Estimate)

December 17, 2015

Last Update Submitted That Met QC Criteria

December 14, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1 (Other Identifier: Mobile Health and Wellness Program)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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