<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03262324</url>
  </required_header>
  <id_info>
    <org_study_id>2017-09</org_study_id>
    <nct_id>NCT03262324</nct_id>
  </id_info>
  <brief_title>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</brief_title>
  <official_title>Reliability and Validity of the Turkish Version of the Visual Analogue Scale Foot and Ankle (VAS-FA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hasan Kalyoncu University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hasan Kalyoncu University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      There have previously been no validated a specific foot and ankle patient-reported outcome&#xD;
      measures in Turkish. The Visual Analogue Scale Foot and Ankle (VAS-FA) will translated and&#xD;
      adapted into Turkish language. Thereafter, 200 patients who had foot and ankle disorders or&#xD;
      surgery will complete VAS-FA questionnaire set on two separate occasions. Analyses included&#xD;
      testing of ﬂoor-ceiling effect, internal consistency, reproducibility, and validity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 30, 2020</start_date>
  <completion_date type="Actual">August 30, 2021</completion_date>
  <primary_completion_date type="Actual">March 30, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>VAS-FA Turkish version</measure>
    <time_frame>1 week</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Foot Function Index (FFI)</measure>
    <time_frame>1 week</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Form-36 (SF-36)</measure>
    <time_frame>1 week</time_frame>
    <description>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%.</description>
  </secondary_outcome>
  <enrollment type="Actual">69</enrollment>
  <condition>Ankle Injuries and Disorders</condition>
  <condition>Foot Injuries and Disorders</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>VAS-FA Turkish version</intervention_name>
    <description>Self-reported outcome questionnaires</description>
    <other_name>Foot Function Index</other_name>
    <other_name>Short Form-36</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants must be sedentary person from Turkey and receiving treatment intervention&#xD;
        between study dates for ankle or foot disorders&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18 and 65&#xD;
&#xD;
          -  Participants who have foot and ankle disorders&#xD;
&#xD;
          -  Participants must have an orthopedic intervention last 3 months;&#xD;
&#xD;
               1. Conservative intervention&#xD;
&#xD;
               2. Surgery intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age less than 18 or more than 65&#xD;
&#xD;
          -  Positive medical history concerning the entire lower extremity,&#xD;
&#xD;
               1. Diabetes mellitus&#xD;
&#xD;
               2. Drug abuse&#xD;
&#xD;
               3. Psychiatric diseases&#xD;
&#xD;
               4. Rheumatoid arthritis&#xD;
&#xD;
               5. Neurological diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Serkan Usgu, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Hasan Kalyoncu University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Günseli Usgu, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hasan Kalyoncu University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Can Muslu, MD</last_name>
    <role>Study Chair</role>
    <affiliation>İstanbul Haseki Training and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hasan kalyoncu üniversity</name>
      <address>
        <city>Gaziantep</city>
        <zip>27144</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>İstanbul Haseki Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <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.</citation>
    <PMID>23965711</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>21863677</PMID>
  </results_reference>
  <results_reference>
    <citation>Richter, M., Zech, S., Geerling, J., Frink, M., Knobloch, K., &amp; 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.</citation>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>25937413</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>21783078</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>10201543</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>19423644</PMID>
  </results_reference>
  <results_reference>
    <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. doi: 10.1177/107110070402500802.</citation>
    <PMID>15363371</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>21189208</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>29409192</PMID>
  </results_reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>March 15, 2022</last_update_submitted>
  <last_update_submitted_qc>March 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hasan Kalyoncu University</investigator_affiliation>
    <investigator_full_name>Serkan Usgu</investigator_full_name>
    <investigator_title>Assistant Professor of Physiotherapy and Rehabilitation</investigator_title>
  </responsible_party>
  <keyword>Foot and Ankle</keyword>
  <keyword>Disorders</keyword>
  <keyword>Outcome Measure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Ankle Injuries</mesh_term>
    <mesh_term>Foot Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03262324
org study id: 2017-09
nct id: NCT03262324
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Cohort
time perspective: Cross-Sectional
measure: VAS-FA Turkish version
time frame: 1 week
description: 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.
measure: Foot Function Index (FFI)
time frame: 1 week
description: 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.
measure: Short Form-36 (SF-36)
time frame: 1 week
description: 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%.
intervention type: Other
intervention name: VAS-FA Turkish version
description: Self-reported outcome questionnaires
other name: Foot Function Index
other name: Short Form-36
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Serkan Usgu, PhD
role: Study Director
affiliation: Hasan Kalyoncu University
last name: Günseli Usgu, Phd
role: Principal Investigator
affiliation: Hasan Kalyoncu University
last name: Can Muslu, MD
role: Study Chair
affiliation: İstanbul Haseki Training and Research Hospital
facility: 
facility: 
country: Turkey
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.
PMID: 23965711
citation: 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.
PMID: 21863677
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.
citation: 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.
PMID: 25937413
citation: 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.
PMID: 21783078
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.
PMID: 10201543
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.
PMID: 19423644
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. doi: 10.1177/107110070402500802.
PMID: 15363371
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.
PMID: 21189208
citation: 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.
PMID: 29409192
responsible party type: Principal Investigator
investigator affiliation: Hasan Kalyoncu University
investigator full name: Serkan Usgu
investigator title: Assistant Professor of Physiotherapy and Rehabilitation
mesh term: Wounds and Injuries
mesh term: Ankle Injuries
mesh term: Foot Injuries
sharing ipd: Undecided