xml: <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/NCT05977660</url>
    </required_header>
    <id_info>
      <org_study_id>EskisehirTU-SBF-CK-01</org_study_id>
      <nct_id>NCT05977660</nct_id>
    </id_info>
    <brief_title>Turkish Language and Cross-cultural Adaptation of the Cumberland Ankle Instability Tool</brief_title>
    <acronym>CAIT-TR</acronym>
    <official_title>Cross-cultural Adaptation and Cut-off Score Determination of the Turkish Version of the Cumberland Ankle Instability Tool (CAIT-TR)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Eskisehir Technical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Eskisehir Technical 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>
    </oversight_info>
    <brief_summary>
      <textblock>
        Cumberland Ankle Instability Tool (CAIT) is a valid patient-reported outcome measure (PROM)&#xD;
        to determine the presence of ankle instability (AI) and assess its severity. The aim of&#xD;
        current study is to adapt the CAIT into the Turkish language, test its psychometric&#xD;
        properties and determine cut-off score in the Turkish population with AI compare to healthy&#xD;
        counterparts. In order to evaluate the Turkish version of CAIT (CAIT-TR), data will obtaine&#xD;
        from 200-250 participants with and without AI. Test-retest reliability, internal consistency,&#xD;
        cut-off score, and ceiling and floor effects will evaluate.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The foot and ankle are the most common injured body parts after the knee in the general&#xD;
        population and athletes. Ankle sprain, which is the most common injury in the ankle, consists&#xD;
        of more than 80% of all ankle injuries. While the rate of ankle injury among all sports&#xD;
        injuries is 23%, according to a study, the most common sports injury seen among 33 sports is&#xD;
        ankle sprain (76.7%). Taking into account that ankle sprains are considered insignificant by&#xD;
        athletes and coaches and that 40-55% of individuals who experienced ankle sprains for the&#xD;
        first time do not seek medical support and treatment from a healthcare professional, it is&#xD;
        understood that this rate is higher than it seems. Almost half of the ankle sprains (49.3%)&#xD;
        occur during athletic activities, and these ankle sprains that are related to athletic&#xD;
        activity are mostly common in basketball (41.1%), football (9.3%), and soccer (7.9%). The&#xD;
        incidence of ankle sprain is seen higher in the field (i.e. field, court) and team sports&#xD;
        (such as rugby, soccer, volleyball, handball, basketball, American football, Australian&#xD;
        football, Gaelic football, tennis, netball, lacrosse, and field hockey). The incidence of&#xD;
        ankle sprains, which is quite common in athletes and also in the general population, has been&#xD;
        seen as higher in women compared to men, in adults compared to adolescents, and in children&#xD;
        compared to adolescents.&#xD;
  &#xD;
        Despite the acute symptoms of ankle sprain disappearing very quickly, most individuals&#xD;
        develop long-term symptoms such as pain, a feeling of instability, a perception of weakness,&#xD;
        and crepitus, which play a role in the development of chronic ankle instability (CAI) after&#xD;
        the injury. Seventy-four percent of individuals with an ankle sprain show at least one&#xD;
        symptom for 1.5-4 years following the injury, and 32% of individuals with a history of ankle&#xD;
        sprain have chronic complaints even 7 years after the injury. One of the most common of these&#xD;
        permanent problems is CAI and the feeling of &quot;giving way&quot;, which occurs as a result of&#xD;
        multiple recurrences of ankle sprain. Ankle stabilization is an integral part of normal&#xD;
        movement and minimizes the risk of ankle sprain during sports activities.&#xD;
  &#xD;
        Ankle sprains have a high recurrence rate, and approximately 30% of individuals with a&#xD;
        history of ankle sprains experience CAI. CAI is observed within 1 year after the injury in&#xD;
        40.5% of individuals who have had their first ankle sprain, and the incidence of CAI can&#xD;
        reach up to 70% shortly after the sprain. The chronicity of recurrent sprains, the decrease&#xD;
        in physical activity level and quality of life, the increase in post-traumatic ankle&#xD;
        osteoarthritis rates, and the large financial costs cause deterioration in the athletic&#xD;
        performance of athletes. Considering all these results, the necessity of an appropriate&#xD;
        approach to prevent injury and comprehensive rehabilitation programs is a fact.&#xD;
  &#xD;
        Although there are different definitions such as chronic ankle instability, functional ankle&#xD;
        instability, and mechanical ankle instability. The term CAI is most frequently used when&#xD;
        describing patients who report that their symptoms continue after their first ankle sprain,&#xD;
        and the most reported losses associated with CAI are the number/repeat of sprains and the&#xD;
        sensation of giving way in the ankle joint. Ankle instability is a common clinical problem in&#xD;
        athletes, in which various complex mechanical and neuromuscular factors play a role. Two&#xD;
        hypothetical causes of CAI are defined as mechanical instability and functional instability.&#xD;
        Mechanical instability (MI) is defined as ankle movement beyond the physiological limits of&#xD;
        the ankle range of motion. The term laxity is often used synonymously with mechanical&#xD;
        instability. Functional instability (FI) is defined as ankle instability due to&#xD;
        proprioceptive and neuromuscular deficits or the subjective feeling of recurrent and&#xD;
        symptomatic ankle sprains (or both). As it can be understood from here, the perception of&#xD;
        individuals is an important issue in CAI diagnoses.&#xD;
  &#xD;
        Interventions by clinicians and physiotherapists are usually standard medical tests and&#xD;
        practices and their evaluations, which initially provide key information based on various&#xD;
        screening methods, joint range of motion, and joint and tissue stability. With these results,&#xD;
        which do not include the perspective of the individual, in addition to the measurable&#xD;
        characteristics of the individual, it is largely incomprehensible how the patient feels about&#xD;
        his health status. The goal of most healthcare services is to improve patient's well-being,&#xD;
        and patients themselves are probably the ones who can best assess their feelings.&#xD;
        Patient-reported measures of outcome (PROM) convert qualitative entities such as anxiety,&#xD;
        pain, or social functioning that cannot be directly observed, or that are impractical or&#xD;
        impossible to directly observe (for example, the performance of daily activities), into&#xD;
        quantitative scores that can be processed mathematical statements such as patient perceptions&#xD;
        of certain aspects of their own health. PROMs can provide both valid and reliable results&#xD;
        that directly reflect the patient's own perspective, without the interpretation of the doctor&#xD;
        or others, in response to a series of questions asked about patients' views and priorities&#xD;
        regarding the treatment they receive or their own health status, how they feel, their quality&#xD;
        of life, or their functional status. They are questionnaire-like scales that were developed&#xD;
        to measure patients' own assessments of their health and health-related quality of life.&#xD;
        PROMs such as the Western Ontario Shoulder Instability Index (WOSI) for shoulder instability,&#xD;
        knee injury, osteoarthritis outcome score (KOOS) for knee problems, and Victorian Sports&#xD;
        Assessment Institute (VISA) for tendinopathies are widely used in sports health. PROMs, which&#xD;
        are useful clinical tools to obtain information about the perceived health status of&#xD;
        patients, are becoming increasingly popular for clinicians to measure the changes in&#xD;
        patient's health status over time. PROMs are usually general, regional, or disease-specific.&#xD;
        While using scales such as the SF-36 health questionnaire in the general evaluation of health&#xD;
        status, regional scales designed to be sensitive to the characteristics of the population to&#xD;
        assess problems and functions specific to certain regions of the musculoskeletal system, such&#xD;
        as general shoulder, arm and hand disorders (DASH), Victorian sports institute for Achilles&#xD;
        assessment (VISA-A) or condition-specific examples such as patellar tendinopathy (VISA-P).&#xD;
        Disease-specific rating scales are designed to assess function, pain, and problems in&#xD;
        specific conditions. Scales whose reliability, validity, and responsiveness have been&#xD;
        scientifically tested are the most useful scales.&#xD;
  &#xD;
        A common reason for translating and adapting PROMs from one language to another is that there&#xD;
        is an absence of a local language-adapted version of a specific PROM required for clinical or&#xD;
        academic research. If a PROM has been developed using valid methods with data from relevant&#xD;
        patient groups, and there is content relevance and scope for patients, it is a better reason&#xD;
        to translate and adapt an existing PROM than to develop a new PROM. This method is both&#xD;
        easier and less time-consuming. Adapting a PROM to a new language or culture is important.&#xD;
        Even for languages spoken by many people globally in different countries, such as Spanish,&#xD;
        English, and Arabic, there can be quite many versions of the same base language, as the&#xD;
        habits and cultures of different countries can differ significantly. The same word or phrase&#xD;
        may have different connotations and meanings in different countries, or objects may be&#xD;
        described by different words in the same language, depending on culture or geography. Also,&#xD;
        living conditions can be very different in language areas depending on socioeconomic,&#xD;
        religious, and cultural conditions that often vary between countries. Therefore, the content&#xD;
        of items in a PROM may not have the same meaning or precaution when translated into a new&#xD;
        culture.&#xD;
  &#xD;
        Some PROMs are used by clinicians and researchers to evaluate the effects of treatment&#xD;
        interventions for individuals with foot and ankle pathological conditions and subsequent&#xD;
        disorders. Although there are at least 17 PROMs commonly used to evaluate patients with ankle&#xD;
        instability in the literature, only 3 of them were developed by including patients&#xD;
        (Cumberland ankle instability, Lower extremity function scale, Foot and ankle ability&#xD;
        measure) and Cumberland Ankle Instability Tool (CAIT), which is one of these scales with the&#xD;
        best internal consistency and best psychometric properties can be used to diagnose&#xD;
        instability as well as an assessment tool.&#xD;
  &#xD;
        CAIT is a very simple, reliable, and valid measurement tool that is used without comparing&#xD;
        with the contralateral ankle, which consists of 9 questions and is scored between 0 and 30,&#xD;
        developed by Hiller and her colleagues in 2006 to measure the severity of functional ankle&#xD;
        instability. Low scores of the participants indicate poor ankle stability, while high scores&#xD;
        indicate good ankle stability. The International Ankle Consortium (IAC) considers that&#xD;
        patient-reported instability should be measured with valid questionnaires and recommends&#xD;
        using CAIT ≤24 scores as a cut-off value for inclusion criteria. Different cut-off scores&#xD;
        have been revealed in various studies conducted in different groups and cultures. For&#xD;
        example, although it is stated that ≥ 28 scores indicate stability and ≤ 23 scores indicate&#xD;
        instability, Hiller et al. calculated the cut-off score as 27.5. In recent study cut-off&#xD;
        score was calculated as ≤25. Another study conducted on the athlete population, it is stated&#xD;
        that those who score above 28 are unlikely to have AI, while individuals who score ≤27 are&#xD;
        likely to have AI.&#xD;
  &#xD;
        The fact that the original language is English limits CAIT's use of this tool in ankle&#xD;
        instability assessments of many non-English speaking countries and communities around the&#xD;
        world. Testing the psychometric properties of CAIT, which is reliable and valid for English&#xD;
        language and culture. In different languages and cultures, is very important to popularize&#xD;
        the use of this measurement tool. CAIT has been translated from the original language English&#xD;
        to many languages such as Spanish, Brazilian-Portuguese, Korean, Japanese, Dutch, Persian,&#xD;
        French, Cantonese, Taiwanese, Arabic, Thai, Greek, and Urdu. Besides all these, there is also&#xD;
        a digital version of CAIT .&#xD;
  &#xD;
        There are some foot and ankle-specific scales such as the Identification of Functional Ankle&#xD;
        Instability (IdFAI), the Olerud-Molander Ankle Score (OMAS), Foot and Ankle Ability Measure&#xD;
        (FAAM), Foot and Ankle Outcome Score, Self-Reported Foot and Ankle Score which have been&#xD;
        adapted to the Turkish population and language and tested for reliability and validity.&#xD;
  &#xD;
        Since there is no Turkish version of CAIT, it cannot be used by researchers and clinicians&#xD;
        working with Turkish-speaking population to determine ankle instability and severity.&#xD;
        Considering that the demand for such PROM scales, which have widespread applicability to be&#xD;
        used in both clinical and scientific research, is increasing, the aim of the current study is&#xD;
        to adapt CAIT from its original language to Turkish (CAIT-TR) and Turkish culture and examine&#xD;
        its psychometric properties in participants with and without AI.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 29, 2023</start_date>
    <completion_date type="Anticipated">September 15, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 10, 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <target_duration>30 Days</target_duration>
    <primary_outcome>
      <measure>Cumberland Ankle Instabililty Tool (CAIT)</measure>
      <time_frame>two weeks</time_frame>
      <description>CAIT is a very simple, reliable, and valid measurement tool that is used without comparing with the contralateral ankle, which consists of 9 questions and is scored between 0 and 30, developed by Hiller and her colleagues in 2006 to measure the severity of functional ankle instability. Low scores of the participants indicate poor ankle stability, while high scores indicate good ankle stability .</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">250</enrollment>
    <condition>Ankle Injuries</condition>
    <condition>Instability, Joint</condition>
    <arm_group>
      <arm_group_label>With chronic ankle instability (CAI)</arm_group_label>
      <description>Participations with CAI diagnosed by a medical doctor</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control (without CAI)</arm_group_label>
      <description>Participations without CAI who didn't have any ankle injury 2 years before the study recruitment</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Cumberland ankle instability tool for diagnose to determine ankle instability and its severity</intervention_name>
      <description>CAIT is a Patient-reported measures of outcome (PROM) and it is very simple, reliable, and valid measurement tool that is used without comparing with the contralateral ankle, which consists of 9 questions and is scored between 0 and 30, developed by Hiller and her colleagues in 2006 to measure the severity of functional ankle instability. Low scores of the participants indicate poor ankle stability, while high scores indicate good ankle stability.</description>
      <arm_group_label>With chronic ankle instability (CAI)</arm_group_label>
      <arm_group_label>control (without CAI)</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          During the research process, the participants will divide into 2 groups, then data will&#xD;
          collect. Group 1 includes individuals with or without ankle sprain. These are individuals&#xD;
          who do not have a history of injury from sprains and are not seeking treatment for similar&#xD;
          reasons. Group 2 consisted of participants who have at least one sprained ankle&#xD;
          injury/injury at least 2 months ago and who were seeking treatment in the past or on an&#xD;
          ongoing basis.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants consisted of women and men aged between 18 and 35.&#xD;
  &#xD;
            -  The volunteers to be included in the study are male and female individuals who have a&#xD;
               history of ankle instabililty in the last two months at least for the study group and&#xD;
               healthy individuals without any injury and the selection will be made at randomly.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  As criteria for excluding the participants in the study; Those who have a risk of&#xD;
               heart disease, use of pacemaker, epilepsy, transient ischemic attack, stroke or&#xD;
               similar nervous disorders and any similar health problems,&#xD;
  &#xD;
            -  Those with psychiatric, cardiac, pulmonary diseases, pregnant women, those who use&#xD;
               drugs that affect the heart rate and blood pressure, those with systemic,&#xD;
               neuroplastic, inflammation disorders, those with structural back anomalies, and those&#xD;
               who have had lumbar disc herniation complications will not be included in the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>35 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Erdem Atalay, Md. Phd.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Sport Medicine, Eskişehir Osmangazi University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>celil kaçoğlu, assoc. prof.</last_name>
      <phone>+905064017872</phone>
      <email>ckacoglu@eskisehir.edu.tr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Anıl Onur Mercanoglu, Phd.</last_name>
      <phone>+905464586523</phone>
      <email>aomercanoglu@eskisehir.edu.tr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Eskişehir Technical University</name>
        <address>
          <city>Eskişehir</city>
          <state>Tepebaşı</state>
          <zip>26555</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Celil Kaçoğlu, assoc prof</last_name>
        <phone>+905064017872</phone>
        <email>ckacoglu@eskisehir.edu.tr</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Eskisehir Technical University</investigator_affiliation>
      <investigator_full_name>Celil Kaçoğlu</investigator_full_name>
      <investigator_title>Associated profesor</investigator_title>
    </responsible_party>
    <keyword>ankle instability</keyword>
    <keyword>chronic ankle instability</keyword>
    <keyword>cumberland ankle instability tool</keyword>
    <keyword>cross-cultural adaptation</keyword>
    <keyword>validity and reliability</keyword>
    <keyword>self-reported questionnaire</keyword>
    <keyword>CAIT</keyword>
    <keyword>Turkish language and cultural adaptation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Joint Instability</mesh_term>
      <mesh_term>Ankle Injuries</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05977660
  org study id: EskisehirTU-SBF-CK-01
  nct id: NCT05977660
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Cumberland Ankle Instability Tool (CAIT) is a valid patient-reported outcome measure (PROM)
        to determine the presence of ankle instability (AI) and assess its severity. The aim of
        current study is to adapt the CAIT into the Turkish language, test its psychometric
        properties and determine cut-off score in the Turkish population with AI compare to healthy
        counterparts. In order to evaluate the Turkish version of CAIT (CAIT-TR), data will obtaine
        from 200-250 participants with and without AI. Test-retest reliability, internal consistency,
        cut-off score, and ceiling and floor effects will evaluate.
  The foot and ankle are the most common injured body parts after the knee in the general
        population and athletes. Ankle sprain, which is the most common injury in the ankle, consists
        of more than 80% of all ankle injuries. While the rate of ankle injury among all sports
        injuries is 23%, according to a study, the most common sports injury seen among 33 sports is
        ankle sprain (76.7%). Taking into account that ankle sprains are considered insignificant by
        athletes and coaches and that 40-55% of individuals who experienced ankle sprains for the
        first time do not seek medical support and treatment from a healthcare professional, it is
        understood that this rate is higher than it seems. Almost half of the ankle sprains (49.3%)
        occur during athletic activities, and these ankle sprains that are related to athletic
        activity are mostly common in basketball (41.1%), football (9.3%), and soccer (7.9%). The
        incidence of ankle sprain is seen higher in the field (i.e. field, court) and team sports
        (such as rugby, soccer, volleyball, handball, basketball, American football, Australian
        football, Gaelic football, tennis, netball, lacrosse, and field hockey). The incidence of
        ankle sprains, which is quite common in athletes and also in the general population, has been
        seen as higher in women compared to men, in adults compared to adolescents, and in children
        compared to adolescents.
  
        Despite the acute symptoms of ankle sprain disappearing very quickly, most individuals
        develop long-term symptoms such as pain, a feeling of instability, a perception of weakness,
        and crepitus, which play a role in the development of chronic ankle instability (CAI) after
        the injury. Seventy-four percent of individuals with an ankle sprain show at least one
        symptom for 1.5-4 years following the injury, and 32% of individuals with a history of ankle
        sprain have chronic complaints even 7 years after the injury. One of the most common of these
        permanent problems is CAI and the feeling of "giving way", which occurs as a result of
        multiple recurrences of ankle sprain. Ankle stabilization is an integral part of normal
        movement and minimizes the risk of ankle sprain during sports activities.
  
        Ankle sprains have a high recurrence rate, and approximately 30% of individuals with a
        history of ankle sprains experience CAI. CAI is observed within 1 year after the injury in
        40.5% of individuals who have had their first ankle sprain, and the incidence of CAI can
        reach up to 70% shortly after the sprain. The chronicity of recurrent sprains, the decrease
        in physical activity level and quality of life, the increase in post-traumatic ankle
        osteoarthritis rates, and the large financial costs cause deterioration in the athletic
        performance of athletes. Considering all these results, the necessity of an appropriate
        approach to prevent injury and comprehensive rehabilitation programs is a fact.
  
        Although there are different definitions such as chronic ankle instability, functional ankle
        instability, and mechanical ankle instability. The term CAI is most frequently used when
        describing patients who report that their symptoms continue after their first ankle sprain,
        and the most reported losses associated with CAI are the number/repeat of sprains and the
        sensation of giving way in the ankle joint. Ankle instability is a common clinical problem in
        athletes, in which various complex mechanical and neuromuscular factors play a role. Two
        hypothetical causes of CAI are defined as mechanical instability and functional instability.
        Mechanical instability (MI) is defined as ankle movement beyond the physiological limits of
        the ankle range of motion. The term laxity is often used synonymously with mechanical
        instability. Functional instability (FI) is defined as ankle instability due to
        proprioceptive and neuromuscular deficits or the subjective feeling of recurrent and
        symptomatic ankle sprains (or both). As it can be understood from here, the perception of
        individuals is an important issue in CAI diagnoses.
  
        Interventions by clinicians and physiotherapists are usually standard medical tests and
        practices and their evaluations, which initially provide key information based on various
        screening methods, joint range of motion, and joint and tissue stability. With these results,
        which do not include the perspective of the individual, in addition to the measurable
        characteristics of the individual, it is largely incomprehensible how the patient feels about
        his health status. The goal of most healthcare services is to improve patient's well-being,
        and patients themselves are probably the ones who can best assess their feelings.
        Patient-reported measures of outcome (PROM) convert qualitative entities such as anxiety,
        pain, or social functioning that cannot be directly observed, or that are impractical or
        impossible to directly observe (for example, the performance of daily activities), into
        quantitative scores that can be processed mathematical statements such as patient perceptions
        of certain aspects of their own health. PROMs can provide both valid and reliable results
        that directly reflect the patient's own perspective, without the interpretation of the doctor
        or others, in response to a series of questions asked about patients' views and priorities
        regarding the treatment they receive or their own health status, how they feel, their quality
        of life, or their functional status. They are questionnaire-like scales that were developed
        to measure patients' own assessments of their health and health-related quality of life.
        PROMs such as the Western Ontario Shoulder Instability Index (WOSI) for shoulder instability,
        knee injury, osteoarthritis outcome score (KOOS) for knee problems, and Victorian Sports
        Assessment Institute (VISA) for tendinopathies are widely used in sports health. PROMs, which
        are useful clinical tools to obtain information about the perceived health status of
        patients, are becoming increasingly popular for clinicians to measure the changes in
        patient's health status over time. PROMs are usually general, regional, or disease-specific.
        While using scales such as the SF-36 health questionnaire in the general evaluation of health
        status, regional scales designed to be sensitive to the characteristics of the population to
        assess problems and functions specific to certain regions of the musculoskeletal system, such
        as general shoulder, arm and hand disorders (DASH), Victorian sports institute for Achilles
        assessment (VISA-A) or condition-specific examples such as patellar tendinopathy (VISA-P).
        Disease-specific rating scales are designed to assess function, pain, and problems in
        specific conditions. Scales whose reliability, validity, and responsiveness have been
        scientifically tested are the most useful scales.
  
        A common reason for translating and adapting PROMs from one language to another is that there
        is an absence of a local language-adapted version of a specific PROM required for clinical or
        academic research. If a PROM has been developed using valid methods with data from relevant
        patient groups, and there is content relevance and scope for patients, it is a better reason
        to translate and adapt an existing PROM than to develop a new PROM. This method is both
        easier and less time-consuming. Adapting a PROM to a new language or culture is important.
        Even for languages spoken by many people globally in different countries, such as Spanish,
        English, and Arabic, there can be quite many versions of the same base language, as the
        habits and cultures of different countries can differ significantly. The same word or phrase
        may have different connotations and meanings in different countries, or objects may be
        described by different words in the same language, depending on culture or geography. Also,
        living conditions can be very different in language areas depending on socioeconomic,
        religious, and cultural conditions that often vary between countries. Therefore, the content
        of items in a PROM may not have the same meaning or precaution when translated into a new
        culture.
  
        Some PROMs are used by clinicians and researchers to evaluate the effects of treatment
        interventions for individuals with foot and ankle pathological conditions and subsequent
        disorders. Although there are at least 17 PROMs commonly used to evaluate patients with ankle
        instability in the literature, only 3 of them were developed by including patients
        (Cumberland ankle instability, Lower extremity function scale, Foot and ankle ability
        measure) and Cumberland Ankle Instability Tool (CAIT), which is one of these scales with the
        best internal consistency and best psychometric properties can be used to diagnose
        instability as well as an assessment tool.
  
        CAIT is a very simple, reliable, and valid measurement tool that is used without comparing
        with the contralateral ankle, which consists of 9 questions and is scored between 0 and 30,
        developed by Hiller and her colleagues in 2006 to measure the severity of functional ankle
        instability. Low scores of the participants indicate poor ankle stability, while high scores
        indicate good ankle stability. The International Ankle Consortium (IAC) considers that
        patient-reported instability should be measured with valid questionnaires and recommends
        using CAIT ≤24 scores as a cut-off value for inclusion criteria. Different cut-off scores
        have been revealed in various studies conducted in different groups and cultures. For
        example, although it is stated that ≥ 28 scores indicate stability and ≤ 23 scores indicate
        instability, Hiller et al. calculated the cut-off score as 27.5. In recent study cut-off
        score was calculated as ≤25. Another study conducted on the athlete population, it is stated
        that those who score above 28 are unlikely to have AI, while individuals who score ≤27 are
        likely to have AI.
  
        The fact that the original language is English limits CAIT's use of this tool in ankle
        instability assessments of many non-English speaking countries and communities around the
        world. Testing the psychometric properties of CAIT, which is reliable and valid for English
        language and culture. In different languages and cultures, is very important to popularize
        the use of this measurement tool. CAIT has been translated from the original language English
        to many languages such as Spanish, Brazilian-Portuguese, Korean, Japanese, Dutch, Persian,
        French, Cantonese, Taiwanese, Arabic, Thai, Greek, and Urdu. Besides all these, there is also
        a digital version of CAIT .
  
        There are some foot and ankle-specific scales such as the Identification of Functional Ankle
        Instability (IdFAI), the Olerud-Molander Ankle Score (OMAS), Foot and Ankle Ability Measure
        (FAAM), Foot and Ankle Outcome Score, Self-Reported Foot and Ankle Score which have been
        adapted to the Turkish population and language and tested for reliability and validity.
  
        Since there is no Turkish version of CAIT, it cannot be used by researchers and clinicians
        working with Turkish-speaking population to determine ankle instability and severity.
        Considering that the demand for such PROM scales, which have widespread applicability to be
        used in both clinical and scientific research, is increasing, the aim of the current study is
        to adapt CAIT from its original language to Turkish (CAIT-TR) and Turkish culture and examine
        its psychometric properties in participants with and without AI.
  observational model: Other
  time perspective: Cross-Sectional
  measure: Cumberland Ankle Instabililty Tool (CAIT)
  time frame: two weeks
  description: CAIT is a very simple, reliable, and valid measurement tool that is used without comparing with the contralateral ankle, which consists of 9 questions and is scored between 0 and 30, developed by Hiller and her colleagues in 2006 to measure the severity of functional ankle instability. Low scores of the participants indicate poor ankle stability, while high scores indicate good ankle stability .
  arm group label: With chronic ankle instability (CAI)
  description: Participations with CAI diagnosed by a medical doctor
  arm group label: control (without CAI)
  description: Participations without CAI who didn't have any ankle injury 2 years before the study recruitment
  intervention type: Diagnostic Test
  intervention name: Cumberland ankle instability tool for diagnose to determine ankle instability and its severity
  description: CAIT is a Patient-reported measures of outcome (PROM) and it is very simple, reliable, and valid measurement tool that is used without comparing with the contralateral ankle, which consists of 9 questions and is scored between 0 and 30, developed by Hiller and her colleagues in 2006 to measure the severity of functional ankle instability. Low scores of the participants indicate poor ankle stability, while high scores indicate good ankle stability.
  arm group label: With chronic ankle instability (CAI)
  arm group label: control (without CAI)
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 35 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Erdem Atalay, Md. Phd.
  role: Principal Investigator
  affiliation: Department of Sport Medicine, Eskişehir Osmangazi University
  last name: celil kaçoğlu, assoc. prof.
  phone: +905064017872
  email: ckacoglu@eskisehir.edu.tr
  last name: Anıl Onur Mercanoglu, Phd.
  phone: +905464586523
  email: aomercanoglu@eskisehir.edu.tr
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Eskisehir Technical University
  investigator full name: Celil Kaçoğlu
  investigator title: Associated profesor
  mesh term: Joint Instability
  mesh term: Ankle Injuries