- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
August 21, 2017 updated by: Serkan Usgu
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
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
51
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Şahinbey
-
Gaziantep, Şahinbey, Turkey, 27410
- Hasan Kalyoncu University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The professional Turkish-speaking athletes who foot and ankle disorders participate in this study.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
professional athletes
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)
|
Self reported outcome instrument
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
FAAM-T questionnaire
Time Frame: 3 days
|
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.
|
3 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale
Time Frame: 3 days
|
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.
|
3 days
|
|
6 meters shuttle run
Time Frame: 3 days
|
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.
|
3 days
|
|
Triple forward hop
Time Frame: 3 days
|
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
|
3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Sıdıka Fatma Uygur, Prof, Cyprus International University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 20, 2009
Primary Completion (ACTUAL)
May 20, 2014
Study Completion (ACTUAL)
July 12, 2015
Study Registration Dates
First Submitted
August 14, 2017
First Submitted That Met QC Criteria
August 21, 2017
First Posted (ACTUAL)
August 24, 2017
Study Record Updates
Last Update Posted (ACTUAL)
August 24, 2017
Last Update Submitted That Met QC Criteria
August 21, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HEK09/103
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All collected individual participant data
IPD Sharing Time Frame
6 months after publication
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ankle; Injury, Superficial, Multiple (With Foot)
-
Ankara Yildirim Beyazıt UniversityKırıkkale UniversityCompletedAnkle; Injury, Superficial, Multiple (With Foot)Turkey
-
University of Alabama at BirminghamRecruitingInjury; Muscle, Ankle, and Foot, MultipleUnited States
-
University of California, San DiegoSanford Scholars Program Mentor FundingRecruiting
-
Paul J. Juliano, M.D.CompletedAnkle Injury | Foot InjuryUnited States
-
Poznan University of Medical SciencesRecruitingFoot Diseases | Ankle Disease | Ankle Injuries and Disorders | Foot InjuryPoland
-
American Hospital of ParisNot yet recruitingMusic | Regional Anesthesia | Forearm; Injury, Superficial, Multiple (With Elbow)France
-
Paragon 28CompletedAnkle Injuries | Foot InjuryUnited States
-
Poznan University of Medical SciencesCompletedFoot Diseases | Ankle Injuries | Ankle Disease | Foot InjuryPoland
-
Major Extremity Trauma Research ConsortiumCompletedSevere Distal Tibia Injury | Severe Ankle Injury | Severe Foot Injury | Major Soft Tissue Loss | Major Bone Articular Surface Loss | Major Ankle Articular Surface LossUnited States
-
Nell Blake, DPMTerminatedAnkle Injury | Foot InjuryUnited States
Clinical Trials on Foot and Ankle Ability Measure Turkish version (FAAM-T) questionnaire
-
University of BeykentCompleted
-
Bahçeşehir UniversityAcibadem UniversityCompletedInjury Prevention | Dynamic Knee Valgus | Postural StabilityTurkey