Translation, Validity, and Reliability of the Foot Posture Index (FPI-6) - Turkish Version

December 19, 2022 updated by: Gullu Aydın Yagcıoglu, Suleyman Demirel University
Individuals with foot-ankle problems (plantar fasciitis, metarsalgia, pes planus, pes planovalgus/varus) will be included in the study. Permission was obtained from the research group that developed the scale to use the Original Foot Posture Index-6 (FPI-6). Cross-cultural adaptation of the FPI-6 will be made in line with the guidelines published by Ruberto and Beaton. First of all, the FPI-6 will be translated into Turkish by two translators whose native language is Turkish and who can speak English at an advanced level. Translations will be compared and discussed, and a Turkish version will be obtained with the equivalents that best represent each item in the texts. Secondly, this retranslated text will be independently translated back into English by two native English translators. In the third stage, two texts written in English will be synthesized by the authors, thus reaching a consensus on a single translation. Finally, the inconsistent parts of the text will be checked by a multidisciplinary team consisting of two native English-speaking translators, members of the English language and literature department, authors who developed the scale, and physiotherapists. Two independent physiotherapists will evaluate the participants' foot posture indexes by FPI-6 for inter-rater reliability. In addition, patients' quality of life, foot functions, hindfoot profiles will be evaluated. For the calculation of validity between measurements, rater-1 will apply the FPI-6 again to the same participants after 15 days for intra-rater reliability. Patients' functional independence, activities of daily living, and quality of life will also be evaluated for criterion validity. American Orthopedic Foot and Ankle Society-AOFAS, SF-36 and Foot Function Index questionnaires will be applied for the validity of FPI-6.

Study Overview

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Isparta, Turkey, 32100
        • Güllü Aydın Yağcıoğlu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study group will consist of individuals between the ages of 18-65 with foot problems.

Description

Inclusion Criteria:

  • being between the ages of 18-65,
  • having foot-ankle problems (plantar fasciitis, metatarsalgia, pes planus, pes planovalgus/varus, hallux valgus, pes cavus, pain)

Exclusion Criteria:

  • Having undergone any lower extremity surgery in the last two years,
  • patients with congenital foot deformity and neurological problems,
  • Individuals with lower or upper extremity pathology or a cognitive problem that may prevent or limit the application of the test protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Foot Posture Index (FPI-6)
Time Frame: 10 minutes
PI-6 is a valid and reliable assessment tool for pediatrics in which 6 items are scored separately for the right and left feet while the patient was in an upright position in a relaxed posture with their body-weight evenly distributed on the both feet. Each item is scored as -2, -1, 0, 1, 2 and the assessment categorized as follows: 0 to +5 normal; +6 to +9 pronated; 10+ higly pronated; -1 to -4 supianted; and -5 to -12 higly supinated.
10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Foot Function Index
Time Frame: 10 minutes
Foot Function Index consists of 23 items with 3 subgroups as pain, disability and activity limitation. While the nine-item pain subscale measures the level of foot pain in various situations, the 9-item disability subscale determines the degree of difficulty in performing various functional activities depending on foot problems.
10 minutes
American Orthopedic Foot and Ankle Society-AOFAS
Time Frame: 10 minutes
American Orthopedic Foot and Ankle Society-AOFAS; This method, which evaluates the foot alignment and functional status of the participants, is the valid and reliable scoring system of the Turkish version developed by the American Foot and Ankle Orthopedic Society. The pain subscale is evaluated over a total of 40 points, the function subscale is evaluated over a total of 50 points, and the foot alignment subscale is evaluated over a total of 10 points. Higher scores indicate a better situation.
10 minutes
SF-36
Time Frame: 15 minutes
The SF-36 QoL test includes a total of 36 self-assessment questions that are classified into eight domains: physical functioning with ten questions, role-physical with four, bodily pain with two, general health with five, social functioning with two, role-emotional with three, mental health with five and vitality with four. The reference period for all of the questions was the last four weeks prior to the interview.
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2022

Primary Completion (Actual)

November 20, 2022

Study Completion (Actual)

November 29, 2022

Study Registration Dates

First Submitted

October 11, 2022

First Submitted That Met QC Criteria

October 11, 2022

First Posted (Actual)

October 13, 2022

Study Record Updates

Last Update Posted (Actual)

December 21, 2022

Last Update Submitted That Met QC Criteria

December 19, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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