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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Turkey
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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:

  1. Participants should be professional athletes
  2. Age ranges must be 18-40 years old

  3. Clinical diagnosis of ankle and foot injury

    1. Acute condition
    2. Chronic condition
  4. Injuries must to happened in sport activities.

Exclusion Criteria:

  1. If athletes had injuries to hip, knee, lower leg within the previous 6 months before the study.
  2. The history of surgery to the above-mentioned areas.

  3. Coexisting musculoskeletal injuries in other body parts, or chronic conditions.

    1. Systematic diseases
    2. Neurological or vascular conditions.
    3. Alcohol abuse
    4. 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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Self reported outcome instrument

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Serkan Usgu

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 20, 2009

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 20, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 12, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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)

Clinical Trials on Foot and Ankle Ability Measure Turkish version (FAAM-T) questionnaire

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings