An observational study in Foot Deformities and Flatfoot, sponsored by Paloma López Ros. Not yet recruiting. Open to participants aged 6 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-15.
Sponsored by Paloma López Ros · Observational
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
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
173 studies on the registry are indexed under Flatfoot; 44 are open to participants now.
This study's planned enrollment of 100 is above the median of 47 across 48 observational studies indexed under Flatfoot.
Browse Flatfoot studies →This is the only study on the registry with Paloma López Ros as lead sponsor.
Compared within Flatfoot, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Foot Deformities. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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
Clinical assessment of standing foot posture using the Spanish translation of the Foot Posture Index (FPI-6). This tool evaluates six criteria: 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 on a scale from -2 to +2. The tool will be applied to a sample of children (from 5 years old) and adults to evaluate its psychometric properties, including reliability and internal consistency
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.
Time frame: 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.
Time frame: At Baseline (Day 1)
Criterion Validity
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
Time frame: At Baseline (Day 1)
No study locations are listed for this record.
Plan to share: Undecided
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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