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NCT Number: NCT07590297

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

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

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

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

Primary outcomes

  1. Intra-rater and Inter-rater Reliability of the Spanish FPI-6

    Time frame: Baseline and 7-14 days later

    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.

  2. Internal Consistency of the Spanish FPI-6

    Time frame: At 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 outcomes

  1. Criterion Validity

    Time frame: At 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

Study contacts

Contact information is provided by the study sponsor or research team.

Paloma López Ros, PhD

CONTACT

[email protected]

+34656928127

Sponsors and collaborators

Lead sponsor

Paloma López Ros

Other

Registry information

Official study title

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

Acronym: FPI-6-ES

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 15, 2026
Registry last updated
May 15, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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