Health TrialsbyHealthPanel

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

ConditionsFoot DeformitiesFlatfoot
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-89
SponsorPaloma López Ros

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

    Other intervention

    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

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

    Other intervention

    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

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: General Population (Children and Adults)1 intervention

Trial outcomes

Primary outcomes

1

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
2

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)

Secondary outcomes

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)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Paloma López Ros

Lead sponsor

Universidad Miguel Hernandez de Elche

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: