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

Ankle Injuries and Disorders Clinical Trial

Official title:

Reliability and Validity of the Turkish Version of the Visual Analogue Scale Foot and Ankle (VAS-FA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03262324
• Other study ID #: 2017-09
• Status: Completed
• Start date: September 30, 2020
• Est. completion date: August 30, 2021

Study information

• Verified date: March 2022
• Source: Hasan Kalyoncu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: August 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Injuries and Disorders
• Disease
• Foot Injuries
• Foot Injuries and Disorders
• Wounds and Injuries

Intervention

Other:
• VAS-FA Turkish version
Self-reported outcome questionnaires

Locations

Country	Name	City	State
Turkey	Hasan kalyoncu üniversity	Gaziantep
Turkey	Istanbul Haseki Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Hasan Kalyoncu University

Country where clinical trial is conducted

Turkey, 

References & Publications (10)

Angthong C, Chernchujit B, Suntharapa T, Harnroongroj T. Visual analogue scale foot and ankle: validity and reliability of Thai version of the new outcome score in subjective form. J Med Assoc Thai. 2011 Aug;94(8):952-7. — View Citation

Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83. — View Citation

Button G, Pinney S. A meta-analysis of outcome rating scales in foot and ankle surgery: is there a valid, reliable, and responsive system? Foot Ankle Int. 2004 Aug;25(8):521-5. — View Citation

Goldstein CL, Schemitsch E, Bhandari M, Mathew G, Petrisor BA. Comparison of different outcome instruments following foot and ankle trauma. Foot Ankle Int. 2010 Dec;31(12):1075-80. doi: 10.3113/FAI.2010.1075. — View Citation

Hunt KJ, Hurwit D. Use of patient-reported outcome measures in foot and ankle research. J Bone Joint Surg Am. 2013 Aug 21;95(16):e118(1-9). doi: 10.2106/JBJS.L.01476. Review. — View 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. — View Citation

Nair AV, Shamsuddin K, John PS, Hämäläinen JA, Kurien MA. Correlation of visual analogue scale foot and ankle (VAS-FA) to AOFAS score in malleolar fractures using Indian language questionnare. Foot Ankle Surg. 2015 Jun;21(2):125-31. doi: 10.1016/j.fas.201 — View Citation

Repo JP, Tukiainen EJ, Roine RP, Kautiainen H, Lindahl J, Ilves O, Järvenpää S, Häkkinen 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.2 — View 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.

Stüber J, Zech S, Bay R, Qazzaz A, Richter M. Normative data of the Visual Analogue Scale Foot and Ankle (VAS FA) for pathological conditions. Foot Ankle Surg. 2011 Sep;17(3):166-72. doi: 10.1016/j.fas.2010.05.005. Epub 2010 Jun 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS-FA Turkish version	The VAS-FA contains 20 questions for the patient with ?ve possible answers. For each question a VAS-value from 0 to 100 points is possible. The total value for the entire score (all 20 questions answered) is therefore 0-2000 points. This total value is then divided by 20, resulting in a possible total score ranging from 0 to 100 points.	1 week
Secondary	Foot Function Index (FFI)	It is a self-administered index consisting of 23 items divided into three subscales. To obtain a subscale score, the item scores for subscales are totaled and then divided by the maximum total possible for all of the subscale items that the patient indicates is applicable. Therefore, subscale scores range from 0 to 100, with higher scores indicating greater impairment. A total foot function score is derived by calculating the average of the three subscale scores.	1 week
Secondary	Short Form-36 (SF-36)	Completion of the 36 items yielded an 8-subscale profile of patient functional health and well being, as well as empirically derived physical and mental health component summary (PCS and MCS) measures. The subscales are scored as percentages and the summary measures are scaled to provide a score out of 50%.	1 week