AzTrials
AzTrials

Ankle; Injury, Superficial, Multiple (With Foot)NCT03259750

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.

An observational study of Ankle; Injury, Superficial, Multiple (With Foot), run by Serkan Usgu at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 40 years
What is being tested?
Foot and Ankle Ability Measure Turkish version (FAAM-T) questionnaire
How many people
51 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Aug 2009to 12 Jul 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: The professional Turkish-speaking athletes who foot and ankle disorders participate in this study.

Who may be able to join

  • Participants should be professional athletes
  • Age ranges must be 18-40 years old
  • Clinical diagnosis of ankle and foot injury
  • Acute condition
  • Chronic condition
  • Injuries must to happened in sport activities.

Who cannot join

  • If athletes had injuries to hip, knee, lower leg within the previous 6 months before the study.
  • The history of surgery to the above-mentioned areas.
  • Coexisting musculoskeletal injuries in other body parts, or chronic conditions.
  • Systematic diseases
  • Neurological or vascular conditions.
  • Alcohol abuse
  • Psychiatric disorders

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Hasan Kalyoncu University

    Gaziantep, Şahinbey, 27410

Other trials in Turkey (Türkiye)

About this study

Official title: Validity and Reliability of the Foot and Ankle Ability Measure Turkish Version for Athletes

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

Being tested
Foot and Ankle Ability Measure Turkish version (FAAM-T) questionnaire
Keywords
Self-reported outcome instrument, Sport, Ankle and foot, Injury
Medical subject headings
Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Foot and Ankle Ability Measure Turkish version (FAAM-T) questionnaireOther

    Self reported outcome instrument

Study groups in NCT03259750
Study groupRoleWhat they receive
professional athletesathlete 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)
Receives: Other: Foot and Ankle Ability Measure Turkish version (FAAM-T) questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. FAAM-T questionnaire

    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.

    Measured: 3 days

Secondary outcomes (3)

  1. Visual Analogue Scale

    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.

    Measured: 3 days

  2. 6 meters shuttle run

    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.

    Measured: 3 days

  3. Triple forward hop

    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

    Measured: 3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2017
  2. Study start20 Aug 2009
  3. Primary completion20 May 2014
  4. Study completion12 Jul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case crossover
Time perspective
Prospective
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03259750
Sponsor's protocol ID
HEK09/103
Status last verified
Aug 2017
First submitted
14 Aug 2017
Last updated
24 Aug 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All collected individual participant data

Publications

  • 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.

    PubMed 27597231

  • 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.

    PubMed 16309613

  • 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.

    PubMed 18345343

  • 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.

    PubMed 21303520

  • 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.

    PubMed 26878102

  • 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.

    PubMed 27633016

  • 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.

    PubMed 26219160

  • 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.

    PubMed 25536950

  • 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.

    PubMed 25310247

  • 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.

    PubMed 25134631

  • 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.

    PubMed 22381198

  • 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.

    PubMed 17366962

  • 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.

    PubMed 22488189

  • 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.

    PubMed 26207439

Questions about this trial

What is this clinical trial studying?

An observational study of Ankle; Injury, Superficial, Multiple (With Foot), run by Serkan Usgu at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FAAM-T questionnaire (time frame: 3 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03259750, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in