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
1 other identifier
interventional
61
0 countries
N/A
Brief Summary
The purpose of this study is to investigate the efficay of functional plantar orthoses on flatfoot in children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2013
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 10, 2015
CompletedFirst Posted
Study publicly available on registry
December 17, 2015
CompletedDecember 17, 2015
December 1, 2015
3 months
December 10, 2015
December 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
One year
Study Arms (2)
Functional plantar orthoses
ACTIVE COMPARATORFunctional plantar orthoses in polypropylene with Medial Heel Skive technique
Placebo plantar orthoses
PLACEBO COMPARATORPlantar orthoses made in Ethil Vinyl Acetate (22º Shore) without correction of the pronation
Interventions
Eligibility Criteria
You may qualify if:
- Flexible flatfoot
You may not qualify if:
- Congenital Vertical talus
- Tarsal coalition
- Neuromuscular disease
- Ligamentous laxity
- Previous history of surgery on lower limb
- Previous orthotic treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
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.
PMID: 35080267DERIVEDEvans 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.
PMID: 35029841DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Javier Pascual Huerta, PhD
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDIV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Student (Podiatrist)
Study Record Dates
First Submitted
December 10, 2015
First Posted
December 17, 2015
Study Start
January 1, 2013
Primary Completion
April 1, 2013
Study Completion
May 1, 2014
Last Updated
December 17, 2015
Record last verified: 2015-12