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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02633566
Enrollment
61
Registered
2015-12-17
Start date
2013-01-31
Completion date
2014-05-31
Last updated
2015-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Flexible Flatfoot

Keywords

Flatfoot, orthoses, children

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.

Interventions

Sponsors

Fresno, Raquel Lopez, M.D.
Lead SponsorINDIV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
3 Years to 4 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
X-ray measurements of the angles: talus-calcaneus, talus-navicular and talus-first metatarsal angle.One yearBefore 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026