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

Fresno, Raquel Lopez, M.D.

Status: Completed

Conditions: Flexible Flatfoot

Treatments: Device: Plantar orthoses

Study type: Interventional

Identifiers

NCT02633566

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Details and patient eligibility

About

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

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 3 to 4 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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61 participants in 2 patient groups, including a placebo group

Functional plantar orthoses

Active Comparator group

Description:

Functional plantar orthoses in polypropylene with Medial Heel Skive technique

Treatment:

Device: Plantar orthoses

Placebo plantar orthoses

Placebo Comparator group

Description:

Plantar orthoses made in Ethil Vinyl Acetate (22º Shore) without correction of the pronation

Treatment:

Device: Plantar orthoses