NCT03259750

Brief 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 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

August 20, 2009

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2014

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2015

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 24, 2017

Completed
Last Updated

August 24, 2017

Status Verified

August 1, 2017

Enrollment Period

4.8 years

First QC Date

August 14, 2017

Last Update Submit

August 21, 2017

Conditions

Keywords

Self-reported outcome instrumentSportAnkle and footInjury

Outcome Measures

Primary Outcomes (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.

    3 days

Secondary Outcomes (3)

  • Visual Analogue Scale

    3 days

  • 6 meters shuttle run

    3 days

  • Triple forward hop

    3 days

Study Arms (1)

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)

Other: Foot and Ankle Ability Measure Turkish version (FAAM-T) questionnaire

Interventions

Self reported outcome instrument

professional athletes

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, Şahinbey, 27410, Turkey (Türkiye)

Location

Related Publications (14)

  • 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: 27597231BACKGROUND
  • 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.

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Serkan Usgu, PhD

    Hasan Kalyoncu University

    PRINCIPAL INVESTIGATOR
  • Yavuz Yakut, Prof

    Hasan Kalyoncu University

    STUDY CHAIR
  • Sıdıka Fatma Uygur, Prof

    Cyprus International University

    STUDY DIRECTOR
  • Gunseli Usgu, PhD

    Hasan Kalyoncu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Physiotherapy and Rehabilitation

Study Record Dates

First Submitted

August 14, 2017

First Posted

August 24, 2017

Study Start

August 20, 2009

Primary Completion

May 20, 2014

Study Completion

July 12, 2015

Last Updated

August 24, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will share

All collected individual participant data

Shared Documents
STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
Time Frame
6 months after publication

Locations