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

Flexible Flatfoot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02633566
• Other study ID #: 1
• Status: Completed
• Phase: N/A
• First received: December 10, 2015
• Last updated: December 14, 2015
• Start date: January 2013
• Est. completion date: May 2014

Study information

• Verified date: December 2015
• Source: Fresno, Raquel Lopez, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: May 2014
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 4 Years

Eligibility

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

Related Conditions & MeSH terms

• Flatfoot
• Flexible Flatfoot

Intervention

Device:
• Plantar orthoses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fresno, Raquel Lopez, M.D.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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