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
About this trial
This is an interventional treatment trial for Flexible Flatfoot focused on measuring Flatfoot, orthoses, children
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
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
NCT ID
NCT02633566
First Posted
December 10, 2015
Last Updated
December 14, 2015
Sponsor
Fresno, Raquel Lopez, M.D.
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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