Flat FeetNCT03954821
How Prefabricated Plantar Insoles Can Reduce the Pronation
An observational study of Flat Feet, run by University of Extremadura.
Trial summary
Pronation is a very common foot deformity in population. Plantar insoles are one way to treat it, and even correct it, but there are several kind of treatments. In this study we try to prove if prefabricated foot insoles are a solution to correct pronation in adults. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Flat Feet
- What is being tested?
- prefabricated insoles
- Type of treatment
- Medical device
- How many people
- 153 participants
- Where
- No sites listed yet
- Study dates
- 23 Sep 2013to 30 Jan 2017
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 'Participant were pupils of Podiatric, Nursing, Forestry and Economic grades of University of Extremadura in Plasencia Campus, Spain. All of the came to Podiatric University Clinic Of University of Extremadura, Spain to be recruided in the present study. After to be informed of the features and targets of this study, they were be given an informed consent, answering the doubts. All of them signed the informed consent and they were asked to be engaged to use the right shoes with plantar insoles all the week , 8 hours at least for 6 months.
Who may be able to join
- feet without symptom
- not present joint deformities to difficult the right measure of them
- aged between 18 to 50 years
Who cannot join
- don´t have degenerative ostheoarticular deformities
- don´t have surgery iinterventions of lower limbs
- balance problems
- painful keratopaties or plantar warts that difficults stance phase
- use of others orthopaedics treatements (plantar insoles)
- don´t be able to step correctly and coordinated on platform to inspect the foot posture
About this study
Official title: Effect of the Prefabricated Plantar Insoles to Control Pronation Measured With Foot Posture Index
Pronation is a very common foot deformity in population. Plantar insoles are one way to treat it, and even correct it, but there are several kind of treatments. In this study we try to prove if prefabricated foot insoles are a solution to correct pronation in adults. It has been tested by Foot Posture Index, that it is an objetive clinical test to measure the posture of feet. Foot is clasified in supinated , pronated and neutral.
Read the detailed description
Nowadays several treatments have been described to treat pronation foot posture, althought these ones heven´t proved objetively the improvement and progression of foot deformity like "Foot Posture Index" does,. Foot pronation during walking is a physiological movement at the beginning of stance phase. It is a needed mechanism which allows the lower limb muscles to support the reaction forces from the ground and to give the forefoot wider range of movement . When there is pronation movement in weight bearing of subtalar joint, the calcaneus does a movement of eversión while talus does a plantarflexion and movement of aduction .The movement is raised due to the paralelism of midfoot joints and the forefoot is forced to compensate the rearfoot position, gettting into dorsiflexion and abduction which leads to a flattening of the medial arch. it is known pronation or flatfoot. Pronation movement is a pathology when it happens during the second part of the stance phase, the 25% at the beginning or when deformity is abnormal provoking an excessive rearfoot eversion with flattenig of the medial arch which will lead to a lower limb misalignment . This doesn´t allow the foot to be a rigid part needed to propulsion phase, so muscles must work excessively to give balance. The pronated foot etiology can be congenital or laxity or due to triceps sural shortening, or functional etiology like varus forefoot, metatarsus aductus or tibial posterior insufficiency. There are some secundary painful pathologies which are the most frequent reason of podiatric appointment.. Plantar fascitis is one of the pathologies, and adquired deformities like Hallux Abductus Valgus, Hallux Límitus/Rigidus and other lower limb deformities like medial compatiment ostheoartritis of knee or patellofemoral syndrome.
Pronated foot can be defined like a foot that has rearfoot eversion and medial protusion of the head of talus, forefoot abduction, flatted medial arch and joint movement greater. This shows a flat foot aspect, depending on the grades of pronation deformity that pacient presents. Both situations are linked and their behaviour are functionally similar.
Attending on consequences and the pathologies derivated of this deformity there are some treatments to stop it and avoid structural alterations of leg and foot. For instance, hallux abductus Valgus, the pathological pronation is the first ray´s extrinsic ethilogic factor, both frequency and capacity to produce pathology.
The compensation of pathological pronation of rearfoot is important to control the deformity evolution. Is commonly accepted by podiatric scientific community that control of pronation can avoid the deformity progression when it is presented (or this progression was slower) and avoid when it wasn´t present yet. Foot Posture Index is a clinical diagnostics tool compounds by 6 criteria that allow to asses reliability the weightbearing foot posture. It is a inexpensive and simple method that doesn´t imply risks to people.
- Conditions
- Flat Feet
- Being tested
- prefabricated insoles
- Keywords
- Foot posture index, foot pronation ,foot orthoses
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prefabricated insolesDevice
| Study group | Role | What they receive |
|---|---|---|
| control group | control group in which all of them present pronated foot without tratment | |
| experimental group | Group in which they have been treated with prefabricated plantar insoles to stop pronation Receives: Device: prefabricated insoles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot Posture Index
Foot Posture Index is a diagnostic tool to measure the foot posture while it is weightbearing. The Foot Posture Index is a 6-item foot posture assessment with the subject standing relaxed in a bipedal position, The 6 items of FPI include talar head palpation, curves above and below the lateral melleoli, calcaneal angle, talonavicular bulge, medial longitudinal arch and forefoot to rearfoot alignment. Each item was scored on a 5-point scale between -2 and +2 and provides a total sum of all items between -12 (highly supinated) and +12(highly pronated).
Measured: 5 minutes total assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start23 Sep 2013
- Primary completion20 Nov 2014
- Study completion30 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Flat FeetStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 153 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Victoria Cáceres, University of Extremadura
- Investigators
- Julian F Garcia, Nursing, Study director, University of Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03954821
- Sponsor's protocol ID
- UExtremadura
- Status last verified
- May 2019
- First submitted
- 15 May 2019
- Last updated
- 20 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Barton CJ, Levinger P, Crossley KM, Webster KE, Menz HB. Relationships between the Foot Posture Index and foot kinematics during gait in individuals with and without patellofemoral pain syndrome. J Foot Ankle Res. 2011 Mar 14;4:10. doi: 10.1186/1757-1146-4-10.
PubMed 21401957Benhamú S (2011). Factores pododólogicos predictivos de la laxitud ligamentosa en la población adulta [Tesis doctoral]. Departamento de Podología. Sevilla, Universidad de Sevilla.
Cornwall MW, McPoil TG. Relationship between static foot posture and foot mobility. J Foot Ankle Res. 2011 Jan 18;4:4. doi: 10.1186/1757-1146-4-4.
PubMed 21244705Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
PubMed 12900694Edwards MR, Jack J, Singh SK (2008). Tibialis posterior dysfunction. CurrOrthop 22(3):185-192.
Fuller EA. The windlass mechanism of the foot. A mechanical model to explain pathology. J Am Podiatr Med Assoc. 2000 Jan;90(1):35-46. doi: 10.7547/87507315-90-1-35.
PubMed 10659531Irving DB, Cook JL, Young MA, Menz HB. Obesity and pronated foot type may increase the risk of chronic plantar heel pain: a matched case-control study. BMC Musculoskelet Disord. 2007 May 17;8:41. doi: 10.1186/1471-2474-8-41.
PubMed 17506905Levinger P, Murley GS, Barton CJ, Cotchett MP, McSweeney SR, Menz HB. A comparison of foot kinematics in people with normal- and flat-arched feet using the Oxford Foot Model. Gait Posture. 2010 Oct;32(4):519-23. doi: 10.1016/j.gaitpost.2010.07.013. Epub 2010 Aug 8.
PubMed 20696579Michaud T (1996). Foot orthoses and other forms of conservative foot cares. Massachusetts: Williams and Wilkins.
Nielsen RG, Rathleff MS, Moelgaard CM, Simonsen O, Kaalund S, Olesen CG, Christensen FB, Kersting UG. Video based analysis of dynamic midfoot function and its relationship with Foot Posture Index scores. Gait Posture. 2010 Jan;31(1):126-30. doi: 10.1016/j.gaitpost.2009.09.012. Epub 2009 Oct 24.
PubMed 19854653Razeghi M, Batt ME. Foot type classification: a critical review of current methods. Gait Posture. 2002 Jun;15(3):282-91. doi: 10.1016/s0966-6362(01)00151-5.
PubMed 11983503Redmond AC, Crosbie J, Ouvrier RA. Development and validation of a novel rating system for scoring standing foot posture: the Foot Posture Index. Clin Biomech (Bristol). 2006 Jan;21(1):89-98. doi: 10.1016/j.clinbiomech.2005.08.002. Epub 2005 Sep 21.
PubMed 16182419Reina M, Lafuente G, Munuera PV. Efecto de las Ortesis Plantares en las Mujeres con Hallux Abductus Valgus Leve y Moderado en Estática. Rev Esp Podol 2010; 21(5): 170-175.
Rodríguez E. Estudio de los Efectos de los Soportes Plantares en la prevención y/o tratamiento del HAV. Rev Esp Podol 1993; 4(7): 323-330.
Sánchez Rodríguez R (2011). Influencia del índice de Postura del pie en las presiones plantares durante la marcha. [Tesis doctoral]. Departamento de Enfermería. Plasencia, Universidad de Extremadura.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Prefabricated Plantar Insoles to Control Pronation Measured With Foot Posture Index
- ClinicalTrials.gov ID
- NCT03954821
- Acronym / sponsor ID
- UExtremadura
- Conditions
- Flat Feet
- Keywords
- Foot posture index, foot pronation ,foot orthoses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- University of ExtremaduraUniversity, hospital or other
- Study start
- 23 Sep 2013 (actual)
- Primary completion
- 20 Nov 2014 (actual)
- Study completion
- 30 Jan 2017 (actual)
- First posted
- 17 May 2019 (actual)
- 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.
Pronation is a very common foot deformity in population. Plantar insoles are one way to treat it, and even correct it, but there are several kind of treatments. In this study we try to prove if prefabricated foot insoles are a solution to correct pronation in adults. It has been tested by Foot Posture Index, that it is an objetive clinical test to measure the posture of feet. Foot is clasified in supinated , pronated and neutral.
Detailed description
Nowadays several treatments have been described to treat pronation foot posture, althought these ones heven´t proved objetively the improvement and progression of foot deformity like "Foot Posture Index" does,. Foot pronation during walking is a physiological movement at the beginning of stance phase. It is a needed mechanism which allows the lower limb muscles to support the reaction forces from the ground and to give the forefoot wider range of movement . When there is pronation movement in weight bearing of subtalar joint, the calcaneus does a movement of eversión while talus does a plantarflexion and movement of aduction .The movement is raised due to the paralelism of midfoot joints and the forefoot is forced to compensate the rearfoot position, gettting into dorsiflexion and abduction which leads to a flattening of the medial arch. it is known pronation or flatfoot. Pronation movement is a pathology when it happens during the second part of the stance phase, the 25% at the beginning or when deformity is abnormal provoking an excessive rearfoot eversion with flattenig of the medial arch which will lead to a lower limb misalignment . This doesn´t allow the foot to be a rigid part needed to propulsion phase, so muscles must work excessively to give balance. The pronated foot etiology can be congenital or laxity or due to triceps sural shortening, or functional etiology like varus forefoot, metatarsus aductus or tibial posterior insufficiency. There are some secundary painful pathologies which are the most frequent reason of podiatric appointment.. Plantar fascitis is one of the pathologies, and adquired deformities like Hallux Abductus Valgus, Hallux Límitus/Rigidus and other lower limb deformities like medial compatiment ostheoartritis of knee or patellofemoral syndrome.
Pronated foot can be defined like a foot that has rearfoot eversion and medial protusion of the head of talus, forefoot abduction, flatted medial arch and joint movement greater. This shows a flat foot aspect, depending on the grades of pronation deformity that pacient presents. Both situations are linked and their behaviour are functionally similar.
Attending on consequences and the pathologies derivated of this deformity there are some treatments to stop it and avoid structural alterations of leg and foot. For instance, hallux abductus Valgus, the pathological pronation is the first ray´s extrinsic ethilogic factor, both frequency and capacity to produce pathology.
The compensation of pathological pronation of rearfoot is important to control the deformity evolution. Is commonly accepted by podiatric scientific community that control of pronation can avoid the deformity progression when it is presented (or this progression was slower) and avoid when it wasn´t present yet. Foot Posture Index is a clinical diagnostics tool compounds by 6 criteria that allow to asses reliability the weightbearing foot posture. It is a inexpensive and simple method that doesn´t imply risks to people.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | – | –control group in which all of them present pronated foot without tratment |
| experimental group | – | Device: prefabricated insolesGroup in which they have been treated with prefabricated plantar insoles to stop pronation |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 'Participant were pupils of Podiatric, Nursing, Forestry and Economic grades of University of Extremadura in Plasencia Campus, Spain. All of the came to Podiatric University Clinic Of University of Extremadura, Spain to be recruided in the present study. After to be informed of the features and targets of this study, they were be given an informed consent, answering the doubts. All of them signed the informed consent and they were asked to be engaged to use the right shoes with plantar insoles all the week , 8 hours at least for 6 months.
Key inclusion criteria (3 listed)
- feet without symptom
- not present joint deformities to difficult the right measure of them
- aged between 18 to 50 years
Key exclusion criteria (6 listed)
- don´t have degenerative ostheoarticular deformities
- don´t have surgery iinterventions of lower limbs
- balance problems
- painful keratopaties or plantar warts that difficults stance phase
- use of others orthopaedics treatements (plantar insoles)
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 |
|---|---|---|
| prefabricated insoles | Device | experimental group |
Primary outcome
Foot Posture Index
Time frame: 5 minutes total assessment
Foot Posture Index is a diagnostic tool to measure the foot posture while it is weightbearing. The Foot Posture Index is a 6-item foot posture assessment with the subject standing relaxed in a bipedal position, The 6 items of FPI include talar head palpation, curves above and below the lateral melleoli, calcaneal angle, talonavicular bulge, medial longitudinal arch and forefoot to rearfoot alignment. Each item was scored on a 5-point scale between -2 and +2 and provides a total sum of all items between -12 (highly supinated) and +12(highly pronated).
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 20 May 2019.
- Background: PubMed 21401957Barton CJ, Levinger P, Crossley KM, Webster KE, Menz HB. Relationships between the Foot Posture Index and foot kinematics during gait in individuals with and without patellofemoral pain syndrome. J Foot Ankle Res. 2011 Mar 14;4:10. doi: 10.1186/1757-1146-4-10.
- BackgroundBenhamú S (2011). Factores pododólogicos predictivos de la laxitud ligamentosa en la población adulta [Tesis doctoral]. Departamento de Podología. Sevilla, Universidad de Sevilla.
- Background: PubMed 21244705Cornwall MW, McPoil TG. Relationship between static foot posture and foot mobility. J Foot Ankle Res. 2011 Jan 18;4:4. doi: 10.1186/1757-1146-4-4.
- Background: PubMed 12900694Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
- BackgroundEdwards MR, Jack J, Singh SK (2008). Tibialis posterior dysfunction. CurrOrthop 22(3):185-192.
- Background: PubMed 10659531Fuller EA. The windlass mechanism of the foot. A mechanical model to explain pathology. J Am Podiatr Med Assoc. 2000 Jan;90(1):35-46. doi: 10.7547/87507315-90-1-35.
- Background: PubMed 17506905Irving DB, Cook JL, Young MA, Menz HB. Obesity and pronated foot type may increase the risk of chronic plantar heel pain: a matched case-control study. BMC Musculoskelet Disord. 2007 May 17;8:41. doi: 10.1186/1471-2474-8-41.
- Background: PubMed 20696579Levinger P, Murley GS, Barton CJ, Cotchett MP, McSweeney SR, Menz HB. A comparison of foot kinematics in people with normal- and flat-arched feet using the Oxford Foot Model. Gait Posture. 2010 Oct;32(4):519-23. doi: 10.1016/j.gaitpost.2010.07.013. Epub 2010 Aug 8.
- BackgroundMichaud T (1996). Foot orthoses and other forms of conservative foot cares. Massachusetts: Williams and Wilkins.
- Background: PubMed 19854653Nielsen RG, Rathleff MS, Moelgaard CM, Simonsen O, Kaalund S, Olesen CG, Christensen FB, Kersting UG. Video based analysis of dynamic midfoot function and its relationship with Foot Posture Index scores. Gait Posture. 2010 Jan;31(1):126-30. doi: 10.1016/j.gaitpost.2009.09.012. Epub 2009 Oct 24.
- Background: PubMed 11983503Razeghi M, Batt ME. Foot type classification: a critical review of current methods. Gait Posture. 2002 Jun;15(3):282-91. doi: 10.1016/s0966-6362(01)00151-5.
- Background: PubMed 16182419Redmond AC, Crosbie J, Ouvrier RA. Development and validation of a novel rating system for scoring standing foot posture: the Foot Posture Index. Clin Biomech (Bristol). 2006 Jan;21(1):89-98. doi: 10.1016/j.clinbiomech.2005.08.002. Epub 2005 Sep 21.
- Individual participant dataSharing planned: Undecided
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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.
Julian F Garcia, Nursing study director
University of Extremadura
Questions about this trial
What is this clinical trial studying?
An observational study of Flat Feet, run by University of Extremadura.
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 3 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 20 May 2019. 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. 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?
Foot Posture Index (time frame: 5 minutes total assessment). 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 NCT03954821, which also lists 19 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 20 May 2019.