Foot DeformitiesNCT05579054
Translation, Validity, and Reliability of the Foot Posture Index (FPI-6) - Turkish Version
An observational study of Foot Deformities and Pes Planus, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Foot Deformities, Pes Planus, Hallux Valgus
- What is being tested?
- Foot Posture Index (FPI-6)
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2022to 29 Nov 2022
- How long will I take part?
- 15 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- Adult, Older adult
Study population: The study group will consist of individuals between the ages of 18-65 with foot problems.
Who may be able to join
- being between the ages of 18-65,
- having foot-ankle problems (plantar fasciitis, metatarsalgia, pes planus, pes planovalgus/varus, hallux valgus, pes cavus, pain)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Foot Posture Index (FPI-6)
- Medical subject headings
- Foot Deformities, Flatfoot, Hallux Valgus, Metatarsalgia, Clubfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot Posture Index (FPI-6)Diagnostic test
FPI-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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot Posture Index (FPI-6)
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.
Measured: 10 minutes
Secondary outcomes (3)
Foot Function Index
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.
Measured: 10 minutes
American Orthopedic Foot and Ankle Society-AOFAS
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.
Measured: 10 minutes
SF-36
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.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start20 Sep 2022
- Primary completion20 Nov 2022
- Study completion29 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 45 participants (actual)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gullu Aydın Yagcıoglu, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579054
- Sponsor's protocol ID
- FPI-6
- Status last verified
- Dec 2022
- First submitted
- 11 Oct 2022
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation, Validity, and Reliability of the Foot Posture Index (FPI-6) - Turkish Version
- ClinicalTrials.gov ID
- NCT05579054
- Acronym / sponsor ID
- FPI-6
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 20 Nov 2022 (actual)
- Study completion
- 29 Nov 2022 (actual)
- First posted
- 13 Oct 2022 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Days
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study group will consist of individuals between the ages of 18-65 with foot problems.
Key inclusion criteria (2 listed)
- being between the ages of 18-65,
- having foot-ankle problems (plantar fasciitis, metatarsalgia, pes planus, pes planovalgus/varus, hallux valgus, pes cavus, pain)
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Foot Posture Index (FPI-6)FPI-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. | Diagnostic test | – |
Primary outcome
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.
3 secondary outcomes
Foot Function Index
Time frame: 10 minutes
American Orthopedic Foot and Ankle Society-AOFAS
Time frame: 10 minutes
SF-36
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Foot Deformities and Pes Planus, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot Posture Index (FPI-6) (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2022.