Clinical Trial of the Effect of Functional Orthoses in Children With Flat Feet
NCT ID: NCT02633566
Last Updated: 2015-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
61 participants
INTERVENTIONAL
2013-01-31
2014-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Functional plantar orthoses
Functional plantar orthoses in polypropylene with Medial Heel Skive technique
Plantar orthoses
Placebo plantar orthoses
Plantar orthoses made in Ethil Vinyl Acetate (22ยบ Shore) without correction of the pronation
Plantar orthoses
Interventions
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Plantar orthoses
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Tarsal coalition
* Neuromuscular disease
* Ligamentous laxity
* Previous history of surgery on lower limb
* Previous orthotic treatment
3 Years
4 Years
ALL
No
Sponsors
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Fresno, Raquel Lopez, M.D.
INDIV
Responsible Party
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Raquel Lopez Fresno
PhD Student (Podiatrist)
Principal Investigators
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Javier Pascual Huerta, PhD
Role: STUDY_DIRECTOR
References
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Evans AM, Rome K, Carroll M, Hawke F. Foot orthoses for treating paediatric flat feet. Cochrane Database Syst Rev. 2022 Jan 26;1(1):CD006311. doi: 10.1002/14651858.CD006311.pub4.
Evans AM, Rome K, Carroll M, Hawke F. Foot orthoses for treating paediatric flat feet. Cochrane Database Syst Rev. 2022 Jan 14;1(1):CD006311. doi: 10.1002/14651858.CD006311.pub3.
Other Identifiers
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1
Identifier Type: -
Identifier Source: org_study_id