Translation, Cross-cultural Adaptation, and Validation of the FPI-6 in Spain

NCT07590297 | Not Yet Recruiting

• 1 other identifier: DCC.PLR.260209
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to translate, cross-culturally adapt, and validate the Spanish version of the Foot Posture Index (FPI-6). This clinical tool is widely used to evaluate standing foot posture through six visual criteria. The study aims to provide Spanish-speaking clinicians and researchers with a reliable and valid instrument to assess foot posture in the Spanish population, ensuring that the psychometric properties of the original scale are preserved

Conditions

Foot Deformities; Flatfoot

Keywords

Foot Posture Index; FPI-6; Validation Study; Reliability; Spanish Version

Outcome Measures

Primary Outcomes (2)

• Intra-rater and Inter-rater Reliability of the Spanish FPI-6

  Consistency of the Foot Posture Index (FPI-6) scores evaluated through the Intraclass Correlation Coefficient (ICC). Intra-rater reliability will be assessed by one examiner repeating the test after 1-2 weeks. Inter-rater reliability will be assessed by two examiners evaluating each subject with a one-hour interval.

  Baseline and 7-14 days later

• Internal Consistency of the Spanish FPI-6

  Measured using Cronbach's alpha to ensure that all six items of the FPI-6 contribute coherently to the total score. A value \> 0.70 is expected.

  At Baseline (Day 1)

Secondary Outcomes (1)

• Criterion Validity

  At Baseline (Day 1)

Study Arms (1)

General Population (Children and Adults)

This group includes participants of all ages, including children (from 5 years old) and adults. The study aims to evaluate the psychometric properties of the Spanish version of the Foot Posture Index (FPI-6) across a diverse age range to ensure its validity and reliability in the general Spanish-speaking population

Other: Spanish version of the Foot Posture Index (FPI-6)

Interventions

Spanish version of the Foot Posture Index (FPI-6) OTHER

The assessment consists of the clinical application of the Spanish version of the Foot Posture Index (FPI-6). This is a non-invasive observational method where the investigator evaluates six specific criteria of the foot while the participant stands in a relaxed position. The six criteria include: talar head palpation, supra and infra-malleolar curvature, calcaneal frontal plane position, prominence in the region of the talonavicular joint, congruence of the internal longitudinal arch, and abduction/adduction of the forefoot on the rearfoot. Each item is scored between -2 and +2, providing a total score between -12 and +12

General Population (Children and Adults)

Eligibility Criteria

• Age: 6 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of individuals from the general population in Spain, covering a wide age range that includes children (from 6 years old), adults, and the elderly (up to 89 years). Participants are recruited through convenience sampling from university clinics and local community centers to ensure a diverse representation of foot types (neutral, pronated, and supinated) across different stages of life

You may qualify if:

• Participants aged between 6 and 89 years
• Ability to understand and sign the informed consent form. In the case of minors, written informed consent from parents or legal guardians and child's assent (where applicable) are required
• Ability to maintain a relaxed standing position unassisted for the duration of the clinical assessment

You may not qualify if:

• History of major surgery or significant trauma in the lower limbs or feet.
• Presence of open wounds or active skin infections on the feet at the time of the examination.
• Neurological or musculoskeletal conditions that severely affect balance or standing posture.
• Cognitive impairment that prevents the participant from following simple clinical instructions

Sponsors & Collaborators

• Paloma López Ros: lead

Related Publications (3)

• Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.

  PMID: 11124735 BACKGROUND

• 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: 16182419 BACKGROUND

• Redmond AC, Crane YZ, Menz HB. Normative values for the Foot Posture Index. J Foot Ankle Res. 2008 Jul 31;1(1):6. doi: 10.1186/1757-1146-1-6.

  PMID: 18822155 BACKGROUND

MeSH Terms

Conditions

Foot Deformities; Flatfoot

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Talipes; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jonatan García-Campos, PhD

  Universidad Miguel Hernández

  PRINCIPAL INVESTIGATOR

• Javier Marco-Lledó, PhD

  Universidad Miguel Hernández

  PRINCIPAL INVESTIGATOR

• Vicenta Martínez-Córcoles, PhD

  Universidad Miguel Hernández

  PRINCIPAL INVESTIGATOR

• Roberto Pascual-Gutiérrez, MSc

  Universidad Miguel Hernández

  PRINCIPAL INVESTIGATOR

• Laura Tabernero-Grau, MSc

  Universidad Miguel Hernández

  PRINCIPAL INVESTIGATOR

• David Montoro-Cremades, MSc

  Universidad Miguel Hernández

  PRINCIPAL INVESTIGATOR

• Paloma López Ros, PhD

  Universidad Miguel Hernández

  STUDY DIRECTOR

Central Study Contacts

Paloma López Ros, PhD

CONTACT

+34656928127; plopez@umh.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, PhD

Study Record Dates

• First Submitted: May 9, 2026
• First Posted: May 15, 2026
• Study Start: May 16, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: May 15, 2026

Record last verified: 2026-05