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

Hallux Valgus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05579054
• Other study ID #: FPI-6
• Status: Completed
• Start date: September 20, 2022
• Est. completion date: November 29, 2022

Study information

• Verified date: December 2022
• Source: Suleyman Demirel University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 29, 2022
• Est. primary completion date: November 20, 2022
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Feet Pes Planus (Flatfoot)
• Flatfoot
• Foot Deformities
• Hallux Valgus
• Metatarsalgia
• Pes Planus

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Turkey	Güllü Aydin Yagcioglu	Isparta

Sponsors (1)

Lead Sponsor	Collaborator
Suleyman Demirel University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 minutes
Secondary	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.	10 minutes
Secondary	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.	10 minutes
Secondary	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.	15 minutes