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

Primary Purpose

Flexible Flatfoot

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Plantar orthoses
Sponsored by
Fresno, Raquel Lopez, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Flexible Flatfoot focused on measuring Flatfoot, orthoses, children

Eligibility Criteria

3 Years - 4 Years (Child)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Functional plantar orthoses

    Placebo plantar orthoses

    Arm Description

    Functional plantar orthoses in polypropylene with Medial Heel Skive technique

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 10, 2015
    Last Updated
    December 14, 2015
    Sponsor
    Fresno, Raquel Lopez, M.D.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02633566
    Brief Title
    Clinical Trial of the Effect of Functional Orthoses in Children With Flat Feet
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2013 (undefined)
    Primary Completion Date
    April 2013 (Actual)
    Study Completion Date
    May 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fresno, Raquel Lopez, M.D.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Flexible Flatfoot
    Keywords
    Flatfoot, orthoses, children

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    61 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Functional plantar orthoses
    Arm Type
    Active Comparator
    Arm Description
    Functional plantar orthoses in polypropylene with Medial Heel Skive technique
    Arm Title
    Placebo plantar orthoses
    Arm Type
    Placebo Comparator
    Arm Description
    Plantar orthoses made in Ethil Vinyl Acetate (22º Shore) without correction of the pronation
    Intervention Type
    Device
    Intervention Name(s)
    Plantar orthoses
    Primary Outcome Measure Information:
    Title
    X-ray measurements of the angles: talus-calcaneus, talus-navicular and talus-first metatarsal angle.
    Description
    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.
    Time Frame
    One year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    4 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Javier Pascual Huerta, PhD
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    35080267
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    35029841
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

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