Clinical trial NCT03262324: The Aim of Study is Translate and Adapt the Visual Analog Scale Foot and Ankle (VAS-FA) Instrument Into Turkish and Psycho-metrically Test Its Reliability and Validity Among Patients Who Had Foot and Ankle Disorders or Surgery
Official title: Reliability and Validity of the Turkish Version of the Visual Analogue Scale Foot and Ankle (VAS-FA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankle Injuries and Disorders
Foot Injuries and Disorders
Keywords: Foot and Ankle
Disorders
Outcome Measure
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2017-08-25
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants must be sedentary person from Turkey and receiving treatment intervention between study dates for ankle or foot disorders

Brief summary: There have previously been no validated a specific foot and ankle patient-reported outcome measures in Turkish. The Visual Analogue Scale Foot and Ankle (VAS-FA) will translated and adapted into Turkish language. Thereafter, 200 patients who had foot and ankle disorders or surgery will complete VAS-FA questionnaire set on two separate occasions. Analyses included testing of ﬂoor-ceiling effect, internal consistency, reproducibility, and validity.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 65
* Participants who have foot and ankle disorders
* Participants must have an orthopedic intervention last 3 months;

  1. Conservative intervention
  2. Surgery intervention

Exclusion Criteria:

* Age less than 18 or more than 65
* Positive medical history concerning the entire lower extremity,

  1. Diabetes mellitus
  2. Drug abuse
  3. Psychiatric diseases
  4. Rheumatoid arthritis
  5. Neurological diseases

Primary outcomes:
measure: VAS-FA Turkish version
timeFrame: 1 week
Secondary outcomes:
measure: Foot Function Index (FFI)
timeFrame: 1 week
measure: Short Form-36 (SF-36)
timeFrame: 1 week
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Hasan kalyoncu üniversity
city: Istanbul
country: Turkey
facility: İstanbul Haseki Training and Research Hospital
Study officials:
affiliation: Hasan Kalyoncu University
name: Serkan Usgu, PhD
role: STUDY_DIRECTOR
affiliation: Hasan Kalyoncu University
name: Günseli Usgu, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: İstanbul Haseki Training and Research Hospital
name: Can Muslu, MD
role: STUDY_CHAIR
References:
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citation: Richter, M., Zech, S., Geerling, J., Frink, M., Knobloch, K., & Krettek, C. (2006). A new foot and ankle outcome score: Questionnaire based, subjective, Visual-Analogue-Scale, validated and computerized. Foot and ankle surgery, 12(4), 191-199.
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citation: Lin CW, Moseley AM, Refshauge KM, Bundy AC. The lower extremity functional scale has good clinimetric properties in people with ankle fracture. Phys Ther. 2009 Jun;89(6):580-8. doi: 10.2522/ptj.20080290. Epub 2009 May 7.
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citation: Repo JP, Tukiainen EJ, Roine RP, Kautiainen H, Lindahl J, Ilves O, Jarvenpaa S, Hakkinen A. Reliability and validity of the Finnish version of the Visual Analogue Scale Foot and Ankle (VAS-FA). Foot Ankle Surg. 2018 Dec;24(6):474-480. doi: 10.1016/j.fas.2017.05.009. Epub 2017 Jun 7.