NCT03262324

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2017

Completed
3.1 years until next milestone

Study Start

First participant enrolled

September 30, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

6 months

First QC Date

August 24, 2017

Last Update Submit

March 15, 2022

Conditions

Keywords

Foot and AnkleDisordersOutcome Measure

Outcome Measures

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.

    1 week

Secondary Outcomes (2)

  • Foot Function Index (FFI)

    1 week

  • Short Form-36 (SF-36)

    1 week

Interventions

Self-reported outcome questionnaires

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

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants must be sedentary person from Turkey and receiving treatment intervention between study dates for ankle or foot disorders

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hasan kalyoncu üniversity

Gaziantep, 27144, Turkey (Türkiye)

Location

İstanbul Haseki Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (10)

  • 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.

  • 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.

  • 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.

    RESULT
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Ankle InjuriesDiseaseFoot Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and InjuriesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Serkan Usgu, PhD

    Hasan Kalyoncu University

    STUDY DIRECTOR
  • Günseli Usgu, Phd

    Hasan Kalyoncu University

    PRINCIPAL INVESTIGATOR
  • Can Muslu, MD

    İstanbul Haseki Training and Research Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Physiotherapy and Rehabilitation

Study Record Dates

First Submitted

August 24, 2017

First Posted

August 25, 2017

Study Start

September 30, 2020

Primary Completion

March 30, 2021

Study Completion

August 30, 2021

Last Updated

March 31, 2022

Record last verified: 2022-03

Locations