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

Translation, Cross-cultural Adaptation, and Validation of the Foot Posture Index (FPI-6) in Spain

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07590297
Acronym
FPI-6-ES
Enrollment
100
Registered
2026-05-15
Start date
2026-05-16
Completion date
2028-05-01
Last updated
2026-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Flatfoot, Foot Deformities

Keywords

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

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

Detailed description

This study follows a prospective, observational design and will be carried out in two phases: Phase 1: Translation and Cross-Cultural Adaptation. Following international standards (forward-backward translation method), the original English FPI-6 will be translated into Spanish by two independent translators. A synthesis version will be created, followed by a back-translation into English to ensure conceptual equivalence. A pilot test will be conducted to ensure the clarity of the items. Phase 2: Validation and Psychometric Evaluation. The Spanish version of the FPI-6 will be administered to a sample of participants. To evaluate reliability, intra-rater and inter-rater reliability will be calculated using the Intraclass Correlation Coefficient (ICC). Internal consistency will be assessed using Cronbach's alpha. Construct validity will be analyzed by comparing FPI-6 scores with other validated clinical measures of foot posture

Interventions

OTHERSpanish version of the Foot Posture Index (FPI-6)

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

Sponsors

Paloma López Ros
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 89 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Intra-rater and Inter-rater Reliability of the Spanish FPI-6Baseline and 7-14 days laterConsistency 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.
Internal Consistency of the Spanish FPI-6At Baseline (Day 1)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.

Secondary

MeasureTime frameDescription
Criterion ValidityAt Baseline (Day 1)Correlation of the Spanish FPI-6 total score with the Foot Function Index (FFI) and the American Orthopaedic Foot and Ankle Society (AOFAS) scale using Spearman's correlation

Contacts

CONTACTPaloma López Ros, PhD
plopez@umh.es+34656928127
PRINCIPAL_INVESTIGATORJonatan García-Campos, PhD

Universidad Miguel Hernández

PRINCIPAL_INVESTIGATORJavier Marco-Lledó, PhD

Universidad Miguel Hernández

PRINCIPAL_INVESTIGATORVicenta Martínez-Córcoles, PhD

Universidad Miguel Hernández

PRINCIPAL_INVESTIGATORRoberto Pascual-Gutiérrez, MSc

Universidad Miguel Hernández

PRINCIPAL_INVESTIGATORLaura Tabernero-Grau, MSc

Universidad Miguel Hernández

PRINCIPAL_INVESTIGATORDavid Montoro-Cremades, MSc

Universidad Miguel Hernández

STUDY_DIRECTORPaloma López Ros, PhD

Universidad Miguel Hernández

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 16, 2026