NCT03954821

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2013

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 23, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2014

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2017

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2019

Completed
Last Updated

May 20, 2019

Status Verified

May 1, 2019

Enrollment Period

1.2 years

First QC Date

May 15, 2019

Last Update Submit

May 17, 2019

Conditions

Flat Feet

Keywords

Foot posture index, foot pronation ,foot orthoses

Outcome Measures

Primary Outcomes (1)

  • 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).

    5 minutes total assessment

Study Arms (2)

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

Interventions

prefabricated insolesDEVICE
experimental group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (19)

  • 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.

    PMID: 21401957BACKGROUND

  • Benhamú S (2011). Factores pododólogicos predictivos de la laxitud ligamentosa en la población adulta [Tesis doctoral]. Departamento de Podología. Sevilla, Universidad de Sevilla.

    BACKGROUND

  • 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.

    PMID: 21244705BACKGROUND

  • Craig 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.

    PMID: 12900694BACKGROUND

  • Edwards MR, Jack J, Singh SK (2008). Tibialis posterior dysfunction. CurrOrthop 22(3):185-192.

    BACKGROUND

  • 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.

    PMID: 10659531BACKGROUND

  • Irving 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.

    PMID: 17506905BACKGROUND

  • Levinger 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.

    PMID: 20696579BACKGROUND

  • Michaud T (1996). Foot orthoses and other forms of conservative foot cares. Massachusetts: Williams and Wilkins.

    BACKGROUND

  • 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.

    PMID: 19854653BACKGROUND

  • Razeghi 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.

    PMID: 11983503BACKGROUND

  • Redmond 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.

    PMID: 16182419BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • Sammarco VJ, Nichols R. Orthotic management for disorders of the hallux. Foot Ankle Clin. 2005 Mar;10(1):191-209. doi: 10.1016/j.fcl.2004.09.003.

    PMID: 15831266BACKGROUND

  • Scott G, Menz HB, Newcombe L. Age-related differences in foot structure and function. Gait Posture. 2007 Jun;26(1):68-75. doi: 10.1016/j.gaitpost.2006.07.009. Epub 2006 Sep 1.

    PMID: 16945538BACKGROUND

  • Teyhen DS, Stoltenberg BE, Collinsworth KM, Giesel CL, Williams DG, Kardouni CH, Molloy JM, Goffar SL, Christie DS, McPoil T. Dynamic plantar pressure parameters associated with static arch height index during gait. Clin Biomech (Bristol). 2009 May;24(4):391-6. doi: 10.1016/j.clinbiomech.2009.01.006. Epub 2009 Feb 25.

    PMID: 19246138BACKGROUND

MeSH Terms

Conditions

Flatfoot

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Julian F Garcia, Nursing

    University of Extremadura

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated teacher of University of Extremadura

Study Record Dates

First Submitted

May 15, 2019

First Posted

May 17, 2019

Study Start

September 23, 2013

Primary Completion

November 20, 2014

Study Completion

January 30, 2017

Last Updated

May 20, 2019

Record last verified: 2019-05