ClinicalTrials.gg
CompletedNCT03262324Updated Mar 31, 2022

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

An observational study in Ankle Injuries and Disorders and Foot Injuries and Disorders, sponsored by Hasan Kalyoncu University. Completed at 2 sites in Turkey. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-03-31.

Sponsored by Hasan Kalyoncu University · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
69
Ages
18 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 38 studies in Ankle Injuries with a site in Turkey — 8 open to participants now, 11 under way, none of them phase 3. Ankle Injuries · Turkey.

Enrollment
7th of 12
69 · median 75
Started
2020
with 1 other
Observational
12 of 38
1 open now
Registered
4th of 38
by date

Among the 38 studies in Ankle Injuries with a site in Turkey, this one is the 7th largest by enrollment of the 12 observational ones, is one of 2 that started in 2020, is one of 12 observational ones, and was the 4th registered.

By phase

38 studies; the count open now beside each. This study's row is marked.

No phase23 · 7 open
Observationalthis study12 · 1 open
Phase 43 · 0 open

By the year they started

First in 2013; this study’s year is marked. 2 started in 2020.

Size and results

Median enrollment 45 across the 26 interventional studies, 75 across the 12 observational. Of the 25 that completed or were terminated, 1 (4%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 38 studies in Ankle Injuries with a site in Turkey, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Ankle Injuries and Disorders
  • Foot Injuries and Disorders

Keywords

  • Foot and Ankle
  • Disorders
  • Outcome Measure
04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
69 participants (actual)
Patient registry
No

Interventions

  • OtherVAS-FA Turkish version

    Self-reported outcome questionnaires

    Also known as: Foot Function Index, Short Form-36

06

What researchers measure

Primary outcomes

  1. VAS-FA Turkish version

    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.

    Time frame: 1 week

Secondary outcomes

  1. 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.

    Time frame: 1 week

  2. 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%.

    Time frame: 1 week

07

Study locations

2 sites
  • Hasan kalyoncu üniversity
    Gaziantep, 27144, Turkey
  • İstanbul Haseki Training and Research Hospital
    Istanbul, Turkey
08

References and documents

Publications

  • 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. PubMed 23965711 ↗
  • 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. PubMed 21863677 ↗
  • 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.
  • Nair AV, Shamsuddin K, John PS, Hamalainen 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.2014.10.006. Epub 2014 Dec 12. PubMed 25937413 ↗
  • Stuber 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. PubMed 21783078 ↗
  • 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. PubMed 10201543 ↗
  • 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. PubMed 19423644 ↗
  • 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. doi: 10.1177/107110070402500802. PubMed 15363371 ↗
  • 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. PubMed 21189208 ↗
  • 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. PubMed 29409192 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2020 to primary completion in Mar 2021, 6 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 24, 2017
First posted
Aug 25, 2017
StartActual
Sep 30, 2020
Primary completionActual
Mar 30, 2021
CompletionActual
Aug 30, 2021
Last update
Mar 31, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03262324
Responsible party
Serkan Usgu (Assistant Professor of Physiotherapy and Rehabilitation, Hasan Kalyoncu University) — Principal investigator
First posted
Aug 25, 2017
Start date
Sep 30, 2020
Primary completion
Mar 30, 2021
Completion
Aug 30, 2021
Last update
Mar 31, 2022

Study contacts

Serkan Usgu, PhD
study director · Hasan Kalyoncu University
Günseli Usgu, Phd
principal investigator · Hasan Kalyoncu University
Can Muslu, MD
study chair · İstanbul Haseki Training and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion