<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/NCT03259750</url>
  </required_header>
  <id_info>
    <org_study_id>HEK09/103</org_study_id>
    <nct_id>NCT03259750</nct_id>
  </id_info>
  <brief_title>The Foot and Ankle Ability Measure (FAAM) is Translated From English to Turkish and Assess the Validity and Reliability in Athletic Population Who Have Foot and Ankle Disorders.</brief_title>
  <official_title>Validity and Reliability of the Foot and Ankle Ability Measure Turkish Version for Athletes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Serkan Usgu</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sport activity induces a relevant risk for lower extremities especially ankle and foot&#xD;
      structures. Athletes who participate in basketball, volleyball and soccer are predisposed.&#xD;
      Self-reported outcome instruments have been used by clinicians to assess the treatment&#xD;
      interventions effectiveness directed at patients with pathologies and identify impairments,&#xD;
      disabilities and quality of life. The assessment of musculoskeletal injuries can be problem&#xD;
      without clinical, radiological examination and on scores from patient-based questionnaires.&#xD;
      The information from these questionnaires provides us good evidence if there is not&#xD;
      interpretation of obtained scores. The Foot and Ankle Ability Measure (FAAM) is a&#xD;
      self-reported outcome instrument for patients with foot and ankle disorders available in&#xD;
      English, German, and French. The FAAM has a sports subscale and activity of daily living&#xD;
      (ADL) subscale that can assess the activities that requires higher level. The aim of this&#xD;
      study is to translate the FAAM into Turkish language, perform a cross-cultural adaptation,&#xD;
      and investigate the reliability, validity of the translated version in athletic population&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 20, 2009</start_date>
  <completion_date type="Actual">July 12, 2015</completion_date>
  <primary_completion_date type="Actual">May 20, 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>FAAM-T questionnaire</measure>
    <time_frame>3 days</time_frame>
    <description>The FAAM-T is comprised of separately scored 21-item Activity of Daily Living (ADL) and 8-item Sports subscales. Each item is scored on a five-point Likert scale from 4 to 0, item score totals can be varied from 0 to 84 for the ADL and from 0 to 32 for the sports subscale. The percentage scores calculated with the total score of each subscale is divided by the highest potential score and multiplied by 100.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Scale</measure>
    <time_frame>3 days</time_frame>
    <description>Visual analogue scale (VAS) is used to represent pain and also functional limitation in sport. The VAS includes numbers, words, figures, to recognize the patients rate the pain or functional limitation level. Responses were converted to numerical scores by measuring the distance from the zero point to the vertical mark. This distance was recorded to the nearest millimeter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6 meters shuttle run</measure>
    <time_frame>3 days</time_frame>
    <description>Participants sprinted up and back twice along a 6 meters course. Participants were required to start with one leg forward on the start line. Time started from the initial forward movement of the athlete and stopped when the athlete crossed the line. Each participants was timed with a hand-held stopwatch and recorded in second.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triple forward hop</measure>
    <time_frame>3 days</time_frame>
    <description>Participants were asked to face parallel down the test &quot;runway,&quot; and, when signaled, participant hopped as far as possible in the forward direction with 3 consecutive hops on the same leg. The distance between the starting line and the place where participant lands on the third hop measured at the heel was recorded in centimeters</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">51</enrollment>
  <condition>Ankle; Injury, Superficial, Multiple (With Foot)</condition>
  <arm_group>
    <arm_group_label>professional athletes</arm_group_label>
    <description>athlete who volunteered in this study that should be a member of a professional sport team, All athletes must complete self reported outcome instrument (FAAM-T)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Foot and Ankle Ability Measure Turkish version (FAAM-T) questionnaire</intervention_name>
    <description>Self reported outcome instrument</description>
    <arm_group_label>professional athletes</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The professional Turkish-speaking athletes who foot and ankle disorders participate in this&#xD;
        study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Participants should be professional athletes&#xD;
&#xD;
          2. Age ranges must be 18-40 years old&#xD;
&#xD;
          3. Clinical diagnosis of ankle and foot injury&#xD;
&#xD;
               1. Acute condition&#xD;
&#xD;
               2. Chronic condition&#xD;
&#xD;
          4. Injuries must to happened in sport activities.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. If athletes had injuries to hip, knee, lower leg within the previous 6 months before&#xD;
             the study.&#xD;
&#xD;
          2. The history of surgery to the above-mentioned areas.&#xD;
&#xD;
          3. Coexisting musculoskeletal injuries in other body parts, or chronic conditions.&#xD;
&#xD;
               1. Systematic diseases&#xD;
&#xD;
               2. Neurological or vascular conditions.&#xD;
&#xD;
               3. Alcohol abuse&#xD;
&#xD;
               4. Psychiatric disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Serkan Usgu, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hasan Kalyoncu University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yavuz Yakut, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Hasan Kalyoncu University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sıdıka Fatma Uygur, Prof</last_name>
    <role>Study Director</role>
    <affiliation>Cyprus International University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gunseli Usgu, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hasan Kalyoncu University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hasan Kalyoncu University</name>
      <address>
        <city>Gaziantep</city>
        <state>Şahinbey</state>
        <zip>27410</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Gonzalez-Sanchez M, Li GZ, Ruiz Munoz M, Cuesta-Vargas AI. Foot and ankle ability measure to measure functional limitations in patients with foot and ankle disorders: a Chinese cross-cultural adaptation and validation. Disabil Rehabil. 2017 Oct;39(21):2182-2189. doi: 10.1080/09638288.2016.1219772. Epub 2016 Sep 6.</citation>
    <PMID>27597231</PMID>
  </reference>
  <results_reference>
    <citation>Martin RL, Irrgang JJ, Burdett RG, Conti SF, Van Swearingen JM. Evidence of validity for the Foot and Ankle Ability Measure (FAAM). Foot Ankle Int. 2005 Nov;26(11):968-83. doi: 10.1177/107110070502601113.</citation>
    <PMID>16309613</PMID>
  </results_reference>
  <results_reference>
    <citation>Carcia CR, Martin RL, Drouin JM. Validity of the Foot and Ankle Ability Measure in athletes with chronic ankle instability. J Athl Train. 2008 Apr-Jun;43(2):179-83. doi: 10.4085/1062-6050-43.2.179.</citation>
    <PMID>18345343</PMID>
  </results_reference>
  <results_reference>
    <citation>Borloz S, Crevoisier X, Deriaz O, Ballabeni P, Martin RL, Luthi F. Evidence for validity and reliability of a French version of the FAAM. BMC Musculoskelet Disord. 2011 Feb 8;12:40. doi: 10.1186/1471-2474-12-40.</citation>
    <PMID>21303520</PMID>
  </results_reference>
  <results_reference>
    <citation>Moreira TS, Magalhaes Lde C, Silva RD, Martin RL, Resende MA. Translation, cross-cultural adaptation and validity of the Brazilian version of the Foot and Ankle Ability Measure questionnaire. Disabil Rehabil. 2016 Dec;38(25):2479-90. doi: 10.3109/09638288.2015.1137979. Epub 2016 Feb 15.</citation>
    <PMID>26878102</PMID>
  </results_reference>
  <results_reference>
    <citation>Hoch JM, Legner JL, Lorete C, Hoch MC. The Validity of the Quick-FAAM in Patients Seeking Treatment for an Acute or Subacute Foot or Ankle Health Condition. J Sport Rehabil. 2017 May 1;26(3):jsr.2016-0089. doi: 10.1123/jsr.2016-0089. Epub 2016 Sep 16.</citation>
    <PMID>27633016</PMID>
  </results_reference>
  <results_reference>
    <citation>Arunakul M, Arunakul P, Suesiritumrong C, Angthong C, Chernchujit B. Validity and Reliability of Thai Version of the Foot and Ankle Ability Measure (FAAM) Subjective Form. J Med Assoc Thai. 2015 Jun;98(6):561-7.</citation>
    <PMID>26219160</PMID>
  </results_reference>
  <results_reference>
    <citation>Weel H, Zwiers R, Azim D, Sierevelt IN, Haverkamp D, van Dijk CN, Kerkhoffs GM. Validity and reliability of a Dutch version of the Foot and Ankle Ability Measure. Knee Surg Sports Traumatol Arthrosc. 2016 Apr;24(4):1348-54. doi: 10.1007/s00167-014-3480-9. Epub 2014 Dec 25.</citation>
    <PMID>25536950</PMID>
  </results_reference>
  <results_reference>
    <citation>Uematsu D, Suzuki H, Sasaki S, Nagano Y, Shinozuka N, Sunagawa N, Fukubayashi T. Evidence of validity for the Japanese version of the foot and ankle ability measure. J Athl Train. 2015 Jan;50(1):65-70. doi: 10.4085/1062-6050-49.3.42. Epub 2014 Oct 13.</citation>
    <PMID>25310247</PMID>
  </results_reference>
  <results_reference>
    <citation>Sartorio F, Vercelli S, Bravini E, Bargeri S, Moroso M, Plebani G, Ferriero G. [Foot and ankle ability measure: cross-cultural translation and validation of the Italian version of the ADL module (FAAM-I/ADL)]. Med Lav. 2014 Jul 15;105(5):357-65. Italian.</citation>
    <PMID>25134631</PMID>
  </results_reference>
  <results_reference>
    <citation>Donahue M, Simon J, Docherty CL. Critical review of self-reported functional ankle instability measures. Foot Ankle Int. 2011 Dec;32(12):1140-6. doi: 10.3113/FAI.2011.1140.</citation>
    <PMID>22381198</PMID>
  </results_reference>
  <results_reference>
    <citation>Martin RL, Irrgang JJ. A survey of self-reported outcome instruments for the foot and ankle. J Orthop Sports Phys Ther. 2007 Feb;37(2):72-84. doi: 10.2519/jospt.2007.2403.</citation>
    <PMID>17366962</PMID>
  </results_reference>
  <results_reference>
    <citation>Arnold BL, Wright CJ, Ross SE. Functional ankle instability and health-related quality of life. J Athl Train. 2011 Nov-Dec;46(6):634-41. doi: 10.4085/1062-6050-46.6.634.</citation>
    <PMID>22488189</PMID>
  </results_reference>
  <results_reference>
    <citation>Hoch JM, Druvenga B, Ferguson BA, Houston MN, Hoch MC. Patient-Reported Outcomes in Male and Female Collegiate Soccer Players During an Athletic Season. J Athl Train. 2015 Sep;50(9):930-6. doi: 10.4085/1062-6050-50.5.03. Epub 2015 Jul 24.</citation>
    <PMID>26207439</PMID>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>August 21, 2017</last_update_submitted>
  <last_update_submitted_qc>August 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-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>Self-reported outcome instrument</keyword>
  <keyword>Sport</keyword>
  <keyword>Ankle and foot</keyword>
  <keyword>Injury</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ankle Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All collected individual participant data</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>6 months after publication</ipd_time_frame>
  </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/NCT03259750
org study id: HEK09/103
nct id: NCT03259750
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Sport activity induces a relevant risk for lower extremities especially ankle and foot
      structures. Athletes who participate in basketball, volleyball and soccer are predisposed.
      Self-reported outcome instruments have been used by clinicians to assess the treatment
      interventions effectiveness directed at patients with pathologies and identify impairments,
      disabilities and quality of life. The assessment of musculoskeletal injuries can be problem
      without clinical, radiological examination and on scores from patient-based questionnaires.
      The information from these questionnaires provides us good evidence if there is not
      interpretation of obtained scores. The Foot and Ankle Ability Measure (FAAM) is a
      self-reported outcome instrument for patients with foot and ankle disorders available in
      English, German, and French. The FAAM has a sports subscale and activity of daily living
      (ADL) subscale that can assess the activities that requires higher level. The aim of this
      study is to translate the FAAM into Turkish language, perform a cross-cultural adaptation,
      and investigate the reliability, validity of the translated version in athletic population
observational model: Case-Crossover
time perspective: Prospective
measure: FAAM-T questionnaire
time frame: 3 days
description: The FAAM-T is comprised of separately scored 21-item Activity of Daily Living (ADL) and 8-item Sports subscales. Each item is scored on a five-point Likert scale from 4 to 0, item score totals can be varied from 0 to 84 for the ADL and from 0 to 32 for the sports subscale. The percentage scores calculated with the total score of each subscale is divided by the highest potential score and multiplied by 100.
measure: Visual Analogue Scale
time frame: 3 days
description: Visual analogue scale (VAS) is used to represent pain and also functional limitation in sport. The VAS includes numbers, words, figures, to recognize the patients rate the pain or functional limitation level. Responses were converted to numerical scores by measuring the distance from the zero point to the vertical mark. This distance was recorded to the nearest millimeter.
measure: 6 meters shuttle run
time frame: 3 days
description: Participants sprinted up and back twice along a 6 meters course. Participants were required to start with one leg forward on the start line. Time started from the initial forward movement of the athlete and stopped when the athlete crossed the line. Each participants was timed with a hand-held stopwatch and recorded in second.
measure: Triple forward hop
time frame: 3 days
description: Participants were asked to face parallel down the test "runway," and, when signaled, participant hopped as far as possible in the forward direction with 3 consecutive hops on the same leg. The distance between the starting line and the place where participant lands on the third hop measured at the heel was recorded in centimeters
arm group label: professional athletes
description: athlete who volunteered in this study that should be a member of a professional sport team, All athletes must complete self reported outcome instrument (FAAM-T)
intervention type: Other
intervention name: Foot and Ankle Ability Measure Turkish version (FAAM-T) questionnaire
description: Self reported outcome instrument
arm group label: professional athletes
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Serkan Usgu, PhD
role: Principal Investigator
affiliation: Hasan Kalyoncu University
last name: Yavuz Yakut, Prof
role: Study Chair
affiliation: Hasan Kalyoncu University
last name: Sıdıka Fatma Uygur, Prof
role: Study Director
affiliation: Cyprus International University
last name: Gunseli Usgu, PhD
role: Principal Investigator
affiliation: Hasan Kalyoncu University
facility: 
country: Turkey
citation: Gonzalez-Sanchez M, Li GZ, Ruiz Munoz M, Cuesta-Vargas AI. Foot and ankle ability measure to measure functional limitations in patients with foot and ankle disorders: a Chinese cross-cultural adaptation and validation. Disabil Rehabil. 2017 Oct;39(21):2182-2189. doi: 10.1080/09638288.2016.1219772. Epub 2016 Sep 6.
PMID: 27597231
citation: Martin RL, Irrgang JJ, Burdett RG, Conti SF, Van Swearingen JM. Evidence of validity for the Foot and Ankle Ability Measure (FAAM). Foot Ankle Int. 2005 Nov;26(11):968-83. doi: 10.1177/107110070502601113.
PMID: 16309613
citation: Carcia CR, Martin RL, Drouin JM. Validity of the Foot and Ankle Ability Measure in athletes with chronic ankle instability. J Athl Train. 2008 Apr-Jun;43(2):179-83. doi: 10.4085/1062-6050-43.2.179.
PMID: 18345343
citation: Borloz S, Crevoisier X, Deriaz O, Ballabeni P, Martin RL, Luthi F. Evidence for validity and reliability of a French version of the FAAM. BMC Musculoskelet Disord. 2011 Feb 8;12:40. doi: 10.1186/1471-2474-12-40.
PMID: 21303520
citation: Moreira TS, Magalhaes Lde C, Silva RD, Martin RL, Resende MA. Translation, cross-cultural adaptation and validity of the Brazilian version of the Foot and Ankle Ability Measure questionnaire. Disabil Rehabil. 2016 Dec;38(25):2479-90. doi: 10.3109/09638288.2015.1137979. Epub 2016 Feb 15.
PMID: 26878102
citation: Hoch JM, Legner JL, Lorete C, Hoch MC. The Validity of the Quick-FAAM in Patients Seeking Treatment for an Acute or Subacute Foot or Ankle Health Condition. J Sport Rehabil. 2017 May 1;26(3):jsr.2016-0089. doi: 10.1123/jsr.2016-0089. Epub 2016 Sep 16.
PMID: 27633016
citation: Arunakul M, Arunakul P, Suesiritumrong C, Angthong C, Chernchujit B. Validity and Reliability of Thai Version of the Foot and Ankle Ability Measure (FAAM) Subjective Form. J Med Assoc Thai. 2015 Jun;98(6):561-7.
PMID: 26219160
citation: Weel H, Zwiers R, Azim D, Sierevelt IN, Haverkamp D, van Dijk CN, Kerkhoffs GM. Validity and reliability of a Dutch version of the Foot and Ankle Ability Measure. Knee Surg Sports Traumatol Arthrosc. 2016 Apr;24(4):1348-54. doi: 10.1007/s00167-014-3480-9. Epub 2014 Dec 25.
PMID: 25536950
citation: Uematsu D, Suzuki H, Sasaki S, Nagano Y, Shinozuka N, Sunagawa N, Fukubayashi T. Evidence of validity for the Japanese version of the foot and ankle ability measure. J Athl Train. 2015 Jan;50(1):65-70. doi: 10.4085/1062-6050-49.3.42. Epub 2014 Oct 13.
PMID: 25310247
citation: Sartorio F, Vercelli S, Bravini E, Bargeri S, Moroso M, Plebani G, Ferriero G. [Foot and ankle ability measure: cross-cultural translation and validation of the Italian version of the ADL module (FAAM-I/ADL)]. Med Lav. 2014 Jul 15;105(5):357-65. Italian.
PMID: 25134631
citation: Donahue M, Simon J, Docherty CL. Critical review of self-reported functional ankle instability measures. Foot Ankle Int. 2011 Dec;32(12):1140-6. doi: 10.3113/FAI.2011.1140.
PMID: 22381198
citation: Martin RL, Irrgang JJ. A survey of self-reported outcome instruments for the foot and ankle. J Orthop Sports Phys Ther. 2007 Feb;37(2):72-84. doi: 10.2519/jospt.2007.2403.
PMID: 17366962
citation: Arnold BL, Wright CJ, Ross SE. Functional ankle instability and health-related quality of life. J Athl Train. 2011 Nov-Dec;46(6):634-41. doi: 10.4085/1062-6050-46.6.634.
PMID: 22488189
citation: Hoch JM, Druvenga B, Ferguson BA, Houston MN, Hoch MC. Patient-Reported Outcomes in Male and Female Collegiate Soccer Players During an Athletic Season. J Athl Train. 2015 Sep;50(9):930-6. doi: 10.4085/1062-6050-50.5.03. Epub 2015 Jul 24.
PMID: 26207439
responsible party type: Sponsor-Investigator
investigator affiliation: Hasan Kalyoncu University
investigator full name: Serkan Usgu
investigator title: Assistant Professor of Physiotherapy and Rehabilitation
mesh term: Ankle Injuries
sharing ipd: Yes
ipd description: All collected individual participant data
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: 6 months after publication