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

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.

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Key information

Conditions

Ankle Injuries and Disorders Ankle Injuries Disease Foot Injuries Foot Injuries and Disorders Leg Injuries Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hasan kalyoncu üniversity, Gaziantep, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Conservative intervention
Surgery intervention

Exclusion criteria

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

Diabetes mellitus
Drug abuse
Psychiatric diseases
Rheumatoid arthritis
Neurological diseases

Treatment and study plan

VAS-FA Turkish version

Other

Self-reported outcome questionnaires

Other names: Foot Function Index, Short Form-36

Primary outcomes

VAS-FA Turkish version

Time frame: 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 outcomes

Foot Function Index (FFI)

Time frame: 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.
Short Form-36 (SF-36)

Time frame: 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%.

Sponsors and collaborators

Lead sponsor

Hasan Kalyoncu University

Other

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Aug 25, 2017
Registry last updated: Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed