Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

How Prefabricated Plantar Insoles Can Reduce the Pronation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03954821
Recruitment Status : Completed
First Posted : May 17, 2019
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
María Victoria Cáceres, University of Extremadura

Brief 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. 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.

Condition or disease Intervention/treatment
Flat Feet Device: prefabricated insoles

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.


Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 153 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 6 Months
Official Title: Effect of the Prefabricated Plantar Insoles to Control Pronation Measured With Foot Posture Index
Actual Study Start Date : September 23, 2013
Actual Primary Completion Date : November 20, 2014
Actual Study Completion Date : January 30, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Device: prefabricated insoles



Primary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • feet without symptom
  • not present joint deformities to difficult the right measure of them
  • aged between 18 to 50 years

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03954821


Sponsors and Collaborators
University of Extremadura
Investigators
Layout table for investigator information
Study Director: Julian F Garcia, Nursing University of Extremadura

Publications:
Benhamú S (2011). Factores pododólogicos predictivos de la laxitud ligamentosa en la población adulta [Tesis doctoral]. Departamento de Podología. Sevilla, Universidad de Sevilla.
Edwards MR, Jack J, Singh SK (2008). Tibialis posterior dysfunction. CurrOrthop 22(3):185-192.
Michaud T (1996). Foot orthoses and other forms of conservative foot cares. Massachusetts: Williams and Wilkins.
Reina 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.
Sánchez Rodríguez R, Martínez Nova A, Escamilla Martinez E, Gómez Martín B (2010). Patrones de presión plantar según el Índice de Postura del Pie. El peu 30(4):184-192.

Layout table for additonal information
Responsible Party: María Victoria Cáceres, Associated teacher of University of Extremadura, University of Extremadura
ClinicalTrials.gov Identifier: NCT03954821     History of Changes
Other Study ID Numbers: UExtremadura
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by María Victoria Cáceres, University of Extremadura:
Foot posture index, foot pronation ,foot orthoses

Additional relevant MeSH terms:
Layout table for MeSH terms
Flatfoot
Talipes
Foot Deformities, Acquired
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Congenital
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities