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/NCT06041243</url>
    </required_header>
    <id_info>
      <org_study_id>ATADEK 2023-10/347</org_study_id>
      <nct_id>NCT06041243</nct_id>
    </id_info>
    <brief_title>Effects of Progressive Exercise Method Using Balance Board in Recreational Athletes With Functional Ankle Instability</brief_title>
    <official_title>Effects of Progressive Exercise Method Using Balance Board in Recreational Athletes With Functional Ankle Instability</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Acibadem University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Acibadem University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Ankle sprains are common injuries in physically active individuals who are involved in sports&#xD;
        such as soccer and volleyball. It is also frequently seen in sedentary individuals who are&#xD;
        not physically active and in people who engage in recreational sports. The recurrence rate of&#xD;
        lateral ankle sprains has been shown to be 80%. Functional Ankle Instability can be defined&#xD;
        as recurrent ankle sprain and/or a &quot;giving away sensation&quot; happens after the initial sprain.&#xD;
  &#xD;
        Conservative treatments are recommended to prevent recurrent injuries and to return to&#xD;
        activity after stability, since the group that usually experiences a feeling of stability&#xD;
        consists of young people. As a treatment, sensory and cognitive notifications and exercise&#xD;
        applications that involve progression by increasingly challenging the individual, including&#xD;
        reducing the support surface and changing the center of gravity, are recommended.&#xD;
  &#xD;
        The Balance Board is a simple, cheap and applicable tool used to improve balance in&#xD;
        treatment. In addition to improving balance, it reduces ankle sprains by up to 50%. The&#xD;
        balance board can train the ankle unidirectionally or multiaxially. Unidirectional balance&#xD;
        usually allows uniaxial movement based on a flat wood and a semicircle underneath. Multiaxial&#xD;
        balance board systems are systems that allow multi-directional movement in all axes&#xD;
        regardless of the position of the foot. It was reported that the performance gained as a&#xD;
        result of the use of the multiaxial balance board was long-lasting and showed a rapid&#xD;
        recovery in injuries. It has been concluded that balance training with a balance board&#xD;
        restores the normal neuromuscular feedback loop by improving mechanoreceptor function, which&#xD;
        contributes to the retraining of the sensorimotor system.&#xD;
  &#xD;
        The use of game elements in treatment is defined as gamification and is a cheap and&#xD;
        alternative method to perform various medical procedures. The increasing interest in&#xD;
        gamification is due to lack of compliance with traditional treatment, increase in health care&#xD;
        costs and inequitable access to health care. Musculoskeletal disorders are one of the leading&#xD;
        causes of physical disability worldwide and gamification can be useful in various&#xD;
        musculoskeletal rehabilitation such as tendonitis, degenerative joint disorders, neural&#xD;
        compressions. Games are more attractive to patients and provide therapists with a wide range&#xD;
        of alternatives for rehabilitation, making the treatment more dynamic and attractive.&#xD;
  &#xD;
        The aim of our study was to investigate the effects of the exercise method on ankle&#xD;
        stability, ankle functionality and enjoyment level of exercise in individuals with functional&#xD;
        ankle instability.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 11, 2023</start_date>
    <completion_date type="Anticipated">March 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 15, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Star Excursion Balance Test</measure>
      <time_frame>4 weeks</time_frame>
      <description>Straight lines are drawn on the floor in anterior, posterior, posterolateral and posteromedial directions. The individual is in the middle of these directions with the leg with instability on the floor. The other leg is asked to reach in these directions. The individual is asked to reach each of these four directions three times and the average is taken.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Foot and Ankle Ability Measure</measure>
      <time_frame>4 weeks</time_frame>
      <description>The Ankle Foot and Ankle Usability Measure consists of 21-questions and 2 subscales (activity of daily living (ADL) subscale and sportive activity subscale). In response to the questions, individuals are asked to mark one of the options &quot;not difficult at all&quot;, &quot;slightly difficult&quot;, &quot;moderately difficult&quot;, &quot;extremely difficult&quot;, &quot;unable to do&quot;, &quot;not applicable&quot;. The total score of the 21-question daily life activity section ranges from 0-84, and the total score of the 8-question sportive activity section ranges from 0-32. A higher score represents a higher functioning of each subscale. In addition, at the end of each subscale, individuals are asked to indicate their function between 0-100%. 100% indicates pre-instability function.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Foot Lift Test</measure>
      <time_frame>4 weeks</time_frame>
      <description>The individual is positioned so that the leg with instability is on the floor and the other leg is slightly flexed at the hip and knee (standing on one leg). For 30 seconds, the number of times he/she lifts the foot on the ground (e.g. lifting the toes) (including touching the opposite foot to the ground) will be tested. Three trials will be made and averaged.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Static Balance</measure>
      <time_frame>4 weeks</time_frame>
      <description>The individual is positioned with the leg with instability on the ground and the other leg slightly flexed at the hip and knee (standing on one leg). How many seconds the individual can balance with eyes closed is measured with a stopwatch. Three trials are performed. The longest time will be evaluated. The maximum time is determined as 60 seconds.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>8 Figure Jump Test</measure>
      <time_frame>4 weeks</time_frame>
      <description>On a 5-meter-long track, the individual is asked to complete the track by jumping with the foot with instability on a path drawn in 8 shapes. It will be checked how many seconds it takes to complete the course with a stopwatch. They will be asked to make two attempts and the shortest time will be evaluated.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Side Jump Test</measure>
      <time_frame>4 weeks</time_frame>
      <description>The individual is asked to jump 10 times with the foot with instability, 30 cm laterally and 30 cm medially. The time it takes to complete the jump is measured with a stopwatch. The individual is asked to try twice and the shortest time will be evaluated.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Short Form-12 Quality of Life Scale</measure>
      <time_frame>4 weeks</time_frame>
      <description>It is a twelve-item questionnaire drawn from the eight subscales of the SF-36. It assesses two general health constructs: physical and mental components. All summary scores range from 0 to 100, where higher scores indicate better quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fear-Avoidance Beliefs Questionnaire</measure>
      <time_frame>4 weeks</time_frame>
      <description>This questionnaire can be used to assess individuals' fear-avoidance beliefs after instability. It includes an 11-question assessment. The total score ranges from 0-66. The higher the score, the higher the fear avoidance belief.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Enjoyment of Physical Activities Scale</measure>
      <time_frame>4 weeks</time_frame>
      <description>This questionnaire aims to assess the enjoyment of the exercises in the intervention by the individuals in the study. The questionnaire consists of eight questions and each question has a score between &quot;1-7&quot;. It is expressed as &quot;1: strongly disagree&quot; and &quot;7: strongly agree&quot;. A high score indicates enjoyment of physical activity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Global Rating of Change Scale</measure>
      <time_frame>4 weeks</time_frame>
      <description>Individuals will be asked to mark one of the numbers &quot;-2 -1 0 +1 +2&quot; on a linear line to evaluate satisfaction after 4 weeks of intervention. &quot;-2: very bad&quot;, &quot;-1: bad&quot;, &quot;0: same&quot;, &quot;+1: good&quot;, &quot;+2: very good.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Ankle Injuries</condition>
    <arm_group>
      <arm_group_label>Treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Game-based balance exercises on BoBo Home Balance Board</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Game-Based Exercises</intervention_name>
      <description>Exercises aimed to improve postural balance with four different games</description>
      <arm_group_label>Treatment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participating recreational sports and doing at least 1.5 hours of cardiovascular or&#xD;
               resistance training per week,&#xD;
  &#xD;
            -  History of one or more ankle sprains,&#xD;
  &#xD;
            -  Functional Ankle Instability Definition (FABIT) score &gt;11,&#xD;
  &#xD;
            -  Having experienced a sprain/loss of instability in the last 6 months,&#xD;
  &#xD;
            -  Volunteering to attend the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of an active injury in both lower extremities,&#xD;
  &#xD;
            -  History of surgery or fracture in both lower extremities,&#xD;
  &#xD;
            -  Visual, auditory and vestibular problems,&#xD;
  &#xD;
            -  Neurological and rheumatologic diseases.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Özgül Öztürk, PhD</last_name>
      <phone>902165004185</phone>
      <email>ozgul.ozturk@acibadem.edu.tr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Behiç Turhan</last_name>
      <phone>905323159888</phone>
      <email>behic.turhan@live.acibadem.edu.tr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Acıbadem Mehmet Ali Aydınlar University</name>
        <address>
          <city>Istanbul</city>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Özgül Öztürk, PhD</last_name>
        <phone>2165004185</phone>
        <email>ozgul.ozturk@acibadem.edu.tr</email>
      </contact>
      <investigator>
        <last_name>Behiç Turhan</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 11, 2023</study_first_submitted>
    <study_first_submitted_qc>September 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Acibadem University</investigator_affiliation>
      <investigator_full_name>Özgül Öztürk</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>ankle instability</keyword>
    <keyword>game-based exercises</keyword>
    <keyword>postural balance</keyword>
    <keyword>physical performance</keyword>
    <keyword>recreational athletes</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ankle Injuries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06041243
  org study id: ATADEK 2023-10/347
  nct id: NCT06041243
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Ankle sprains are common injuries in physically active individuals who are involved in sports
        such as soccer and volleyball. It is also frequently seen in sedentary individuals who are
        not physically active and in people who engage in recreational sports. The recurrence rate of
        lateral ankle sprains has been shown to be 80%. Functional Ankle Instability can be defined
        as recurrent ankle sprain and/or a "giving away sensation" happens after the initial sprain.
  
        Conservative treatments are recommended to prevent recurrent injuries and to return to
        activity after stability, since the group that usually experiences a feeling of stability
        consists of young people. As a treatment, sensory and cognitive notifications and exercise
        applications that involve progression by increasingly challenging the individual, including
        reducing the support surface and changing the center of gravity, are recommended.
  
        The Balance Board is a simple, cheap and applicable tool used to improve balance in
        treatment. In addition to improving balance, it reduces ankle sprains by up to 50%. The
        balance board can train the ankle unidirectionally or multiaxially. Unidirectional balance
        usually allows uniaxial movement based on a flat wood and a semicircle underneath. Multiaxial
        balance board systems are systems that allow multi-directional movement in all axes
        regardless of the position of the foot. It was reported that the performance gained as a
        result of the use of the multiaxial balance board was long-lasting and showed a rapid
        recovery in injuries. It has been concluded that balance training with a balance board
        restores the normal neuromuscular feedback loop by improving mechanoreceptor function, which
        contributes to the retraining of the sensorimotor system.
  
        The use of game elements in treatment is defined as gamification and is a cheap and
        alternative method to perform various medical procedures. The increasing interest in
        gamification is due to lack of compliance with traditional treatment, increase in health care
        costs and inequitable access to health care. Musculoskeletal disorders are one of the leading
        causes of physical disability worldwide and gamification can be useful in various
        musculoskeletal rehabilitation such as tendonitis, degenerative joint disorders, neural
        compressions. Games are more attractive to patients and provide therapists with a wide range
        of alternatives for rehabilitation, making the treatment more dynamic and attractive.
  
        The aim of our study was to investigate the effects of the exercise method on ankle
        stability, ankle functionality and enjoyment level of exercise in individuals with functional
        ankle instability.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Single (Outcomes Assessor)
  measure: Star Excursion Balance Test
  time frame: 4 weeks
  description: Straight lines are drawn on the floor in anterior, posterior, posterolateral and posteromedial directions. The individual is in the middle of these directions with the leg with instability on the floor. The other leg is asked to reach in these directions. The individual is asked to reach each of these four directions three times and the average is taken.
  measure: Foot and Ankle Ability Measure
  time frame: 4 weeks
  description: The Ankle Foot and Ankle Usability Measure consists of 21-questions and 2 subscales (activity of daily living (ADL) subscale and sportive activity subscale). In response to the questions, individuals are asked to mark one of the options "not difficult at all", "slightly difficult", "moderately difficult", "extremely difficult", "unable to do", "not applicable". The total score of the 21-question daily life activity section ranges from 0-84, and the total score of the 8-question sportive activity section ranges from 0-32. A higher score represents a higher functioning of each subscale. In addition, at the end of each subscale, individuals are asked to indicate their function between 0-100%. 100% indicates pre-instability function.
  measure: Foot Lift Test
  time frame: 4 weeks
  description: The individual is positioned so that the leg with instability is on the floor and the other leg is slightly flexed at the hip and knee (standing on one leg). For 30 seconds, the number of times he/she lifts the foot on the ground (e.g. lifting the toes) (including touching the opposite foot to the ground) will be tested. Three trials will be made and averaged.
  measure: Static Balance
  time frame: 4 weeks
  description: The individual is positioned with the leg with instability on the ground and the other leg slightly flexed at the hip and knee (standing on one leg). How many seconds the individual can balance with eyes closed is measured with a stopwatch. Three trials are performed. The longest time will be evaluated. The maximum time is determined as 60 seconds.
  measure: 8 Figure Jump Test
  time frame: 4 weeks
  description: On a 5-meter-long track, the individual is asked to complete the track by jumping with the foot with instability on a path drawn in 8 shapes. It will be checked how many seconds it takes to complete the course with a stopwatch. They will be asked to make two attempts and the shortest time will be evaluated.
  measure: Side Jump Test
  time frame: 4 weeks
  description: The individual is asked to jump 10 times with the foot with instability, 30 cm laterally and 30 cm medially. The time it takes to complete the jump is measured with a stopwatch. The individual is asked to try twice and the shortest time will be evaluated.
  measure: Short Form-12 Quality of Life Scale
  time frame: 4 weeks
  description: It is a twelve-item questionnaire drawn from the eight subscales of the SF-36. It assesses two general health constructs: physical and mental components. All summary scores range from 0 to 100, where higher scores indicate better quality of life.
  measure: Fear-Avoidance Beliefs Questionnaire
  time frame: 4 weeks
  description: This questionnaire can be used to assess individuals' fear-avoidance beliefs after instability. It includes an 11-question assessment. The total score ranges from 0-66. The higher the score, the higher the fear avoidance belief.
  measure: Enjoyment of Physical Activities Scale
  time frame: 4 weeks
  description: This questionnaire aims to assess the enjoyment of the exercises in the intervention by the individuals in the study. The questionnaire consists of eight questions and each question has a score between "1-7". It is expressed as "1: strongly disagree" and "7: strongly agree". A high score indicates enjoyment of physical activity.
  measure: Global Rating of Change Scale
  time frame: 4 weeks
  description: Individuals will be asked to mark one of the numbers "-2 -1 0 +1 +2" on a linear line to evaluate satisfaction after 4 weeks of intervention. "-2: very bad", "-1: bad", "0: same", "+1: good", "+2: very good.
  arm group label: Treatment
  arm group type: Experimental
  description: Game-based balance exercises on BoBo Home Balance Board
  arm group label: Control
  arm group type: No Intervention
  intervention type: Other
  intervention name: Game-Based Exercises
  description: Exercises aimed to improve postural balance with four different games
  arm group label: Treatment
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: No
  last name: Özgül Öztürk, PhD
  phone: 902165004185
  email: ozgul.ozturk@acibadem.edu.tr
  last name: Behiç Turhan
  phone: 905323159888
  email: behic.turhan@live.acibadem.edu.tr
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Acibadem University
  investigator full name: Özgül Öztürk
  investigator title: Assistant Professor
  mesh term: Ankle Injuries
  sharing ipd: No