How Prefabricated Plantar Insoles Can Reduce the Pronation

Completed

• Conditions: Flat Feet
• Interventions: Device: prefabricated insoles

• Registration Number: NCT03954821
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-09-23
• Primary Completion: 2014-11-20
• Study Completion: 2017-01-30
• Status Verified: 2019-05
• Study First Submitted: 2019-05-15
• Study First Submitted QC: 2019-05-15
• Study First Posted: 2019-05-17
• Last Update Submitted: 2019-05-17
• Last Update Posted: 2019-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
experimental group	prefabricated insoles	Group in which they have been treated with prefabricated plantar insoles to stop pronation

Primary Outcome Measures

Name	Time	Method
Foot Posture Index	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).