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

Completed

• Conditions: Ankle Injuries and Disorders; Foot Injuries and Disorders

• Registration Number: NCT03262324
• Lead Sponsor: Hasan Kalyoncu University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-24
• Study First Submitted QC: 2017-08-24
• Study First Posted: 2017-08-25
• Study Start: 2020-09-30
• Primary Completion: 2021-03-30
• Study Completion: 2021-08-30
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-15
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
VAS-FA Turkish version	1 week	The VAS-FA contains 20 questions for the patient with five 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.

Secondary Outcome Measures

Name	Time	Method
Short Form-36 (SF-36)	1 week	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%.
Foot Function Index (FFI)	1 week	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.

Trial Locations

Locations (2)

Hasan kalyoncu üniversity; 🇹🇷 Gaziantep, Turkey

İstanbul Haseki Training and Research Hospital; 🇹🇷 Istanbul, Turkey