- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05579054
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
Status
Completed
Intervention / Treatment
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
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-
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Isparta, Turkey, 32100
- Güllü Aydın Yağcıoğlu
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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.
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10 minutes
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American Orthopedic Foot and Ankle Society-AOFAS
Time Frame: 10 minutes
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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
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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.
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15 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Congenital Abnormalities
- Foot Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Musculoskeletal Abnormalities
- Limb Deformities, Congenital
- Foot Deformities, Acquired
- Lower Extremity Deformities, Congenital
- Talipes
- Hallux Valgus
- Flatfoot
- Foot Deformities
- Foot Deformities, Congenital
- Metatarsalgia
Other Study ID Numbers
- FPI-6
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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