Foot DeformitiesFPI-6-ESNCT07590297
Translation, Cross-cultural Adaptation, and Validation of the FPI-6 in Spain
An observational study of Foot Deformities and Flatfoot, run by Paloma López Ros.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Foot Deformities, Flatfoot
- What is being tested?
- Spanish version of the Foot Posture Index (FPI-6)
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 16 May 2026to May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 89 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Translation, Cross-cultural Adaptation, and Validation of the Foot Posture Index (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
Read the 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
- Conditions
- Foot Deformities, Flatfoot
- Being tested
- Spanish version of the Foot Posture Index (FPI-6)
- Keywords
- Foot Posture Index, FPI-6, Validation Study, Reliability, Spanish Version
- Medical subject headings
- Foot Deformities, Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Spanish version of the Foot Posture Index (FPI-6)Other
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Spanish version of the Foot Posture Index (FPI-6) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: At Baseline (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start16 May 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Foot DeformitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paloma López Ros
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paloma López Ros, Universidad Miguel Hernandez de Elche
- Investigators
- Jonatan García-Campos, PhD, Principal investigator, Universidad Miguel HernándezJavier Marco-Lledó, PhD, Principal investigator, Universidad Miguel HernándezVicenta Martínez-Córcoles, PhD, Principal investigator, Universidad Miguel HernándezRoberto Pascual-Gutiérrez, MSc, Principal investigator, Universidad Miguel HernándezLaura Tabernero-Grau, MSc, Principal investigator, Universidad Miguel HernándezDavid Montoro-Cremades, MSc, Principal investigator, Universidad Miguel HernándezPaloma López Ros, PhD, Study director, Universidad Miguel Hernández
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07590297
- Sponsor's protocol ID
- DCC.PLR.260209
- Acronym
- FPI-6-ES
- Status last verified
- May 2026
- First submitted
- 9 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 11124735Redmond 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.
PubMed 16182419Redmond 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.
PubMed 18822155
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation, Cross-cultural Adaptation, and Validation of the Foot Posture Index (FPI-6) in Spain
- ClinicalTrials.gov ID
- NCT07590297
- Acronym / sponsor ID
- FPI-6-ES / DCC.PLR.260209
- Conditions
- Foot Deformities, Flatfoot
- Keywords
- Foot Posture Index, FPI-6, Validation Study, Reliability, Spanish Version
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Paloma López RosUniversity, hospital or other
- Study start
- 16 May 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| General Population (Children and Adults) | – | Other: Spanish version of the Foot Posture Index (FPI-6)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 |
Who may qualify
- Ages
- 6 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | General Population (Children and Adults) |
| Spanish version of the Foot Posture Index (FPI-6)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 | Other | General Population (Children and Adults) |
Primary outcome
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.
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.
1 secondary outcome
Criterion Validity
Time frame: At Baseline (Day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Background: PubMed 11124735Beaton 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.
- Background: PubMed 16182419Redmond 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.
- Background: PubMed 18822155Redmond 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonatan García-Campos, PhD principal investigator
Universidad Miguel Hernández
Javier Marco-Lledó, PhD principal investigator
Universidad Miguel Hernández
Vicenta Martínez-Córcoles, PhD principal investigator
Universidad Miguel Hernández
Questions about this trial
What is this clinical trial studying?
An observational study of Foot Deformities and Flatfoot, run by Paloma López Ros.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paloma López Ros, PhD (+34656928127, plopez@umh.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-rater and Inter-rater Reliability of the Spanish FPI-6 (time frame: Baseline and 7-14 days later). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07590297, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.