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Completed

NCT Number: NCT03954821

How Prefabricated Plantar Insoles Can Reduce the Pronation

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

prefabricated insoles

Device

Primary outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of Extremadura

Other

Registry information

Official study title

Effect of the Prefabricated Plantar Insoles to Control Pronation Measured With Foot Posture Index

Important dates

Study start
2013
Primary completion
2014
Study completion
2017
First posted
May 17, 2019
Registry last updated
May 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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