Flexible FlatfootNCT02633566
Clinical Trial of the Effect of Functional Orthoses in Children With Flat Feet
A study testing Plantar orthoses in people with Flexible Flatfoot, run by Fresno, Raquel Lopez, M.D..
Trial summary
The purpose of this study is to investigate the efficay of functional plantar orthoses on flatfoot in children. Read more about this study
- Who is it for?
- Ages 3 to 4 years
- Conditions the study is for
- Flexible Flatfoot
- What is being tested?
- Plantar orthoses
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Flexible flatfoot
Who cannot join
- Congenital Vertical talus
- Tarsal coalition
- Neuromuscular disease
- Ligamentous laxity
- Previous history of surgery on lower limb
- Previous orthotic treatment
About this study
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
The purpose of this study is to investigate the efficay of functional plantar orthoses on flatfoot in children.
Read the 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.
- Conditions
- Flexible Flatfoot
- Being tested
- Plantar orthoses
- Keywords
- Flatfoot, orthoses, children
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plantar orthosesDevice
| Study group | Role | What they receive |
|---|---|---|
| Functional plantar orthoses | Active comparator | Functional plantar orthoses in polypropylene with Medial Heel Skive technique Receives: Device: Plantar orthoses |
| Placebo plantar orthoses | Placebo comparator | Plantar orthoses made in Ethil Vinyl Acetate (22º Shore) without correction of the pronation Receives: Device: Plantar orthoses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startJan 2013
- Primary completionApr 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Flexible FlatfootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresno, Raquel Lopez, M.D.
- Responsible party
- Principal investigator, Raquel Lopez Fresno, Fresno, Raquel Lopez, M.D.
- Investigators
- Javier Pascual Huerta, PhD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02633566
- Sponsor's protocol ID
- 1
- Status last verified
- Dec 2015
- First submitted
- 10 Dec 2015
- Last updated
- 17 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 35080267Evans 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.
PubMed 35029841
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02633566
- Acronym / sponsor ID
- 1
- Conditions
- Flexible Flatfoot
- Keywords
- Flatfoot, orthoses, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Fresno, Raquel Lopez, M.D.
- Study start
- Jan 2013
- Primary completion
- Apr 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 17 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional plantar orthoses | Active comparator | Device: Plantar orthosesFunctional plantar orthoses in polypropylene with Medial Heel Skive technique |
| Placebo plantar orthoses | Placebo comparator | Device: Plantar orthosesPlantar orthoses made in Ethil Vinyl Acetate (22º Shore) without correction of the pronation |
Who may qualify
- Ages
- 3 to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Flexible flatfoot
Key exclusion criteria (6 listed)
- Congenital Vertical talus
- Tarsal coalition
- Neuromuscular disease
- Ligamentous laxity
- Previous history of surgery on lower limb
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plantar orthoses | Device | Functional plantar orthoses, Placebo plantar orthoses |
Primary outcome
X-ray measurements of the angles: talus-calcaneus, talus-navicular and talus-first metatarsal angle.
Time frame: One year
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2015.
- Derived from this study: PubMed 35080267Evans 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.
- Derived from this study: PubMed 35029841Evans 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.
Related trials for Flexible Flatfoot
Not yet recruitingObservational study
Tibialis Posterior Muscle Morphology in Flexible Flatfeet Subjects
Flexible Flatfoot
Active, not recruitingObservational study
Clinical and Functional Outcomes After Subtalar Arthroereisis in Pediatric Flexible Flatfoot
Pediatric Flexible Flatfoot
Not yet recruiting
Effect of Foot Orthoses on Kneecap Position in Adults With Flexible Flatfoot
Patellofemoral Joint, Flatfoot
Recruiting
Effects of Hip-Based Versus Knee-Based Exercises on Medial Longitudinal Arch, Dynamic Balance, and Muscle Strength in Flexible Flatfoot
Flexible Flatfoot, Flexible Flatfoot or Pes Planus
Not yet recruiting
Calcaneal Lengthening Osteotomy With Locking Wedge Plate Versus Synthetic PEEK Cage Interposition for Symptomatic Flexible Pes Planovalgus Foot Deformity in Adolescents
Flexible Flatfoot or Pes Planus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier Pascual Huerta, PhD study director
Questions about this trial
What is this clinical trial studying?
A study testing Plantar orthoses in people with Flexible Flatfoot, run by Fresno, Raquel Lopez, M.D..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
X-ray measurements of the angles: talus-calcaneus, talus-navicular and talus-first metatarsal angle. (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02633566, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2015.