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/NCT05998083</url>
    </required_header>
    <id_info>
      <org_study_id>Uskudar71</org_study_id>
      <nct_id>NCT05998083</nct_id>
    </id_info>
    <brief_title>The Effectiveness of Purposeful Exercises in Children Diagnosed With Special Learning Disabilities</brief_title>
    <official_title>Investigation of the Effect of Purposeful Balance and Coordination Exercises on Attention and Quality of Life in Children Diagnosed With Special Learning Disabilities.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Uskudar University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Uskudar 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>
        The aim of the study is to examine the effect of purposeful balance and coordination&#xD;
        exercises on attention and quality of life in children diagnosed with special learning&#xD;
        disabilities.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study was planned as a randomized controlled trial, and children aged 7-17 who were&#xD;
        diagnosed with &quot;Special Learning Disability&quot; in a special education center in Kocaeli-Darica&#xD;
        were included as a sample. Children were divided into experimental and control groups by&#xD;
        randomization. In addition to the individual training program they received from the special&#xD;
        training center, the experimental group was given goal-oriented balance and coordination&#xD;
        exercises for 8 weeks, 2 days a week for 40 minutes. The control group continued only the&#xD;
        individual training program. All participants and their parents were informed about the&#xD;
        study, and an informed consent form was obtained from the participants and their parents. In&#xD;
        order to collect data from the participants; &quot;Leisure Time Activity Questionnaire for&#xD;
        Children&quot; to determine physical activity levels, &quot;Quality of Life Assessment Questionnaire&#xD;
        for Children&quot; to determine their quality of life, &quot;Bruininks-Oseretsky Motor Proficiency Test&#xD;
        2 short form&quot; to evaluate motor skills, &quot;Burdon Attention Test&quot; to measure attention level&#xD;
        used. These tests and forms were repeated before starting the study and at the end of the&#xD;
        study. Pre- and post-intervention data were statistically analyzed and compared.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 1, 2021</start_date>
    <completion_date type="Actual">April 1, 2022</completion_date>
    <primary_completion_date type="Actual">November 1, 2021</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>
      <intervention_model_description>In addition to the individual training program they received from the special training center, the experimental group was given goal-oriented balance and coordination exercises for 40 minutes, 2 days a week.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The Quality of Life Scale for Children (QoL-C)</measure>
      <time_frame>10 weeks</time_frame>
      <description>Quality of Life Scale for Children, parent form for children or adolescents 2-4, 5-7, 8-12, 13-18 years old, and self for children or adolescents 5-7, 8-12, 13-18 years old It consists of a total of 7 forms, including a notification form. This scale questions the last month of children and adolescents. It was developed as a Likert-type scale with 3 options for children aged 5-7 and 5 options for children and adolescents aged 8-18. Items are scored between 0-100. The answer to the question is scored 100 if it is marked as never, 75 if it is marked as rarely, 50 if it is marked as sometimes, 25 if it is marked as often, and 0 if it is marked as almost always. The total score is obtained by summing the scores and dividing by the number of items filled. The score obtained is directly proportional to the quality of life.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Leisure Activity Questionnaire for Children (CPAQ)</measure>
      <time_frame>10 weeks</time_frame>
      <description>The form was filled by the children and their exercise levels were determined by calculations. MET values were classified as low, medium, high and moderately high. Low-intensity activities of 3 METs or less per hour are moderate and high-intensity activities of 3 METs and above. It is considered as moderate (3-5.9 MET), high intensity (6 MET and above), and medium-high intensity (3 MET and above).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>bourdon attention test</measure>
      <time_frame>10 weeks</time_frame>
      <description>Bourdon Test (also dubbed a/b/q Test, ABQ) is an approach to measure focus and attentiveness that requires its taker to spot and cross out the query chars a, b and q in a potpourri of letters.&#xD;
  The test consists of two forms. The first is to find and mark certain letters among mixed book letters; the second one is in the form of finding and marking certain figures among the figures given as mixed. There are a total of 660 letters in the letter form of the test. In the letter form, certain letters are required to be found among the letters. There is no template created, and the practitioner can choose the letters or shapes he wants and ask the children to mark them, so that the practitioner can create his own template.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>bruninks oserertsky engine proficiency test-2(BOT-2)</measure>
      <time_frame>10 weeks</time_frame>
      <description>BOT-2 measures fine and gross motor proficiency, with subtests that focus on stability, mobility, strength, coordination, and object manipulation. The test is tailored to school-aged children and young adults among the ages of 4-21 years, who have varying motor control abilities ranging from normal to mild or moderate.In both the BOT-2 short form (SF) this scale is used to transform the standard score to final categories (1 - well below average; 2 - below average; 3 - average; 4 - above average; 5 - well above average).The four motor-area composite standard scores, discussed below, range from 27 on Manual Coordination to 61 on Fine Manual Control.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">45</enrollment>
    <condition>Lack of; Attention, With Hyperactivity (ADHD)</condition>
    <condition>Specific Learning Disability</condition>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>continued their normal education and physiotherapy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>they continued their normal training and physiotherapy, in addition, purposeful balance and coordination exercises were given for 40 minutes a day, 2 days a week for 8 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>exercise</intervention_name>
      <description>In addition to the individual support training program, the exercise group was given a balance and coordination exercise protocol including 40 minutes, 2 days a week.&#xD;
  These exercises are:&#xD;
  It consisted of warm-up (10 minutes), purposeful balance and coordination exercises (20 minutes), and cool-down (10 minutes) exercises.&#xD;
  Balance and coordination exercises with purpose were created with a series of exercises based on copying the shape of the blocks on the cards placed at the beginning of a track consisting of stations at the end of the track. The stations were composed of &quot;hopscotch station&quot;, &quot;tandem walking station in one line&quot;, &quot;bounce station&quot;, &quot;bucketing ping pong balls station&quot; and &quot;eight running stations&quot;.</description>
      <arm_group_label>experimental group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>control</intervention_name>
      <description>The control group continued only the individual support education program.</description>
      <arm_group_label>control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being diagnosed with Special Learning Disabilities&#xD;
  &#xD;
            -  To be between the ages of 7-15&#xD;
  &#xD;
            -  To attend the special education and rehabilitation center and individual support&#xD;
               training program regularly.&#xD;
  &#xD;
            -  Not having exercise intolerance or any disease that prevents exercise&#xD;
  &#xD;
            -  The child's willingness to participate in the study and the consent of the parent to&#xD;
               participate in the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having physical or psychological disorders in addition to the diagnosis of Special&#xD;
               Learning Disabilities (ADHD, etc.)&#xD;
  &#xD;
            -  Being diagnosed with Special Learning Disabilities and not complying with the age&#xD;
               range&#xD;
  &#xD;
            -  Not attending the individual training program regularly&#xD;
  &#xD;
            -  Parents not giving consent for the child to participate in the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>7 Years</minimum_age>
      <maximum_age>15 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Elif PUNAR</last_name>
      <role>Study Chair</role>
      <affiliation>Uskudar University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Turgay ALTUNALAN</last_name>
      <role>Study Chair</role>
      <affiliation>Karadeniz Technical University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Özel Eğitim Merkezi</name>
        <address>
          <city>Istanbul</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Blanchet M, Assaiante C. Specific Learning Disorder in Children and Adolescents, a Scoping Review on Motor Impairments and Their Potential Impacts. Children (Basel). 2022 Jun 15;9(6):892. doi: 10.3390/children9060892.</citation>
      <PMID>35740829</PMID>
    </reference>
    <reference>
      <citation>Hallawell B, Stephens J, Charnock D. Physical activity and learning disability. Br J Nurs. 2012 May 24-Jun 13;21(10):609-12. doi: 10.12968/bjon.2012.21.10.609.</citation>
      <PMID>22875298</PMID>
    </reference>
    <reference>
      <citation>Bluechardt MH, Wiener J, Shephard RJ. Exercise programmes in the treatment of children with learning disabilities. Sports Med. 1995 Jan;19(1):55-72. doi: 10.2165/00007256-199519010-00005.</citation>
      <PMID>7740247</PMID>
    </reference>
    <reference>
      <citation>Fathi Azar E, Mirzaie H, Jamshidian E, Hojati E. Effectiveness of perceptual-motor exercises and physical activity on the cognitive, motor, and academic skills of children with learning disorders: A systematic review. Child Care Health Dev. 2023 Mar 5. doi: 10.1111/cch.13111. Online ahead of print.</citation>
      <PMID>36872844</PMID>
    </reference>
    <reference>
      <citation>Maiano C, Hue O, Morin AJS, Lepage G, Tracey D, Moullec G. Exercise interventions to improve balance for young people with intellectual disabilities: a systematic review and meta-analysis. Dev Med Child Neurol. 2019 Apr;61(4):406-418. doi: 10.1111/dmcn.14023. Epub 2018 Sep 19.</citation>
      <PMID>30230530</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Uskudar University</investigator_affiliation>
      <investigator_full_name>Dr. Öğr. Üyesi Ömer Şevgin</investigator_full_name>
      <investigator_title>assistant professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Learning Disabilities</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/NCT05998083
  org study id: Uskudar71
  nct id: NCT05998083
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the study is to examine the effect of purposeful balance and coordination
        exercises on attention and quality of life in children diagnosed with special learning
        disabilities.
  The study was planned as a randomized controlled trial, and children aged 7-17 who were
        diagnosed with "Special Learning Disability" in a special education center in Kocaeli-Darica
        were included as a sample. Children were divided into experimental and control groups by
        randomization. In addition to the individual training program they received from the special
        training center, the experimental group was given goal-oriented balance and coordination
        exercises for 8 weeks, 2 days a week for 40 minutes. The control group continued only the
        individual training program. All participants and their parents were informed about the
        study, and an informed consent form was obtained from the participants and their parents. In
        order to collect data from the participants; "Leisure Time Activity Questionnaire for
        Children" to determine physical activity levels, "Quality of Life Assessment Questionnaire
        for Children" to determine their quality of life, "Bruininks-Oseretsky Motor Proficiency Test
        2 short form" to evaluate motor skills, "Burdon Attention Test" to measure attention level
        used. These tests and forms were repeated before starting the study and at the end of the
        study. Pre- and post-intervention data were statistically analyzed and compared.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: In addition to the individual training program they received from the special training center, the experimental group was given goal-oriented balance and coordination exercises for 40 minutes, 2 days a week.
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: The Quality of Life Scale for Children (QoL-C)
  time frame: 10 weeks
  description: Quality of Life Scale for Children, parent form for children or adolescents 2-4, 5-7, 8-12, 13-18 years old, and self for children or adolescents 5-7, 8-12, 13-18 years old It consists of a total of 7 forms, including a notification form. This scale questions the last month of children and adolescents. It was developed as a Likert-type scale with 3 options for children aged 5-7 and 5 options for children and adolescents aged 8-18. Items are scored between 0-100. The answer to the question is scored 100 if it is marked as never, 75 if it is marked as rarely, 50 if it is marked as sometimes, 25 if it is marked as often, and 0 if it is marked as almost always. The total score is obtained by summing the scores and dividing by the number of items filled. The score obtained is directly proportional to the quality of life.
  measure: Leisure Activity Questionnaire for Children (CPAQ)
  time frame: 10 weeks
  description: The form was filled by the children and their exercise levels were determined by calculations. MET values were classified as low, medium, high and moderately high. Low-intensity activities of 3 METs or less per hour are moderate and high-intensity activities of 3 METs and above. It is considered as moderate (3-5.9 MET), high intensity (6 MET and above), and medium-high intensity (3 MET and above).
  measure: bourdon attention test
  time frame: 10 weeks
  description: Bourdon Test (also dubbed a/b/q Test, ABQ) is an approach to measure focus and attentiveness that requires its taker to spot and cross out the query chars a, b and q in a potpourri of letters.
  The test consists of two forms. The first is to find and mark certain letters among mixed book letters; the second one is in the form of finding and marking certain figures among the figures given as mixed. There are a total of 660 letters in the letter form of the test. In the letter form, certain letters are required to be found among the letters. There is no template created, and the practitioner can choose the letters or shapes he wants and ask the children to mark them, so that the practitioner can create his own template.
  measure: bruninks oserertsky engine proficiency test-2(BOT-2)
  time frame: 10 weeks
  description: BOT-2 measures fine and gross motor proficiency, with subtests that focus on stability, mobility, strength, coordination, and object manipulation. The test is tailored to school-aged children and young adults among the ages of 4-21 years, who have varying motor control abilities ranging from normal to mild or moderate.In both the BOT-2 short form (SF) this scale is used to transform the standard score to final categories (1 - well below average; 2 - below average; 3 - average; 4 - above average; 5 - well above average).The four motor-area composite standard scores, discussed below, range from 27 on Manual Coordination to 61 on Fine Manual Control.
  arm group label: control group
  arm group type: Active Comparator
  description: continued their normal education and physiotherapy
  arm group label: experimental group
  arm group type: Experimental
  description: they continued their normal training and physiotherapy, in addition, purposeful balance and coordination exercises were given for 40 minutes a day, 2 days a week for 8 weeks.
  intervention type: Other
  intervention name: exercise
  description: In addition to the individual support training program, the exercise group was given a balance and coordination exercise protocol including 40 minutes, 2 days a week.
  These exercises are:
  It consisted of warm-up (10 minutes), purposeful balance and coordination exercises (20 minutes), and cool-down (10 minutes) exercises.
  Balance and coordination exercises with purpose were created with a series of exercises based on copying the shape of the blocks on the cards placed at the beginning of a track consisting of stations at the end of the track. The stations were composed of "hopscotch station", "tandem walking station in one line", "bounce station", "bucketing ping pong balls station" and "eight running stations".
  arm group label: experimental group
  intervention type: Other
  intervention name: control
  description: The control group continued only the individual support education program.
  arm group label: control group
  criteria: 
  gender: All
  minimum age: 7 Years
  maximum age: 15 Years
  healthy volunteers: No
  last name: Elif PUNAR
  role: Study Chair
  affiliation: Uskudar University
  last name: Turgay ALTUNALAN
  role: Study Chair
  affiliation: Karadeniz Technical University
  facility: 
  country: Turkey
  citation: Blanchet M, Assaiante C. Specific Learning Disorder in Children and Adolescents, a Scoping Review on Motor Impairments and Their Potential Impacts. Children (Basel). 2022 Jun 15;9(6):892. doi: 10.3390/children9060892.
  PMID: 35740829
  citation: Hallawell B, Stephens J, Charnock D. Physical activity and learning disability. Br J Nurs. 2012 May 24-Jun 13;21(10):609-12. doi: 10.12968/bjon.2012.21.10.609.
  PMID: 22875298
  citation: Bluechardt MH, Wiener J, Shephard RJ. Exercise programmes in the treatment of children with learning disabilities. Sports Med. 1995 Jan;19(1):55-72. doi: 10.2165/00007256-199519010-00005.
  PMID: 7740247
  citation: Fathi Azar E, Mirzaie H, Jamshidian E, Hojati E. Effectiveness of perceptual-motor exercises and physical activity on the cognitive, motor, and academic skills of children with learning disorders: A systematic review. Child Care Health Dev. 2023 Mar 5. doi: 10.1111/cch.13111. Online ahead of print.
  PMID: 36872844
  citation: Maiano C, Hue O, Morin AJS, Lepage G, Tracey D, Moullec G. Exercise interventions to improve balance for young people with intellectual disabilities: a systematic review and meta-analysis. Dev Med Child Neurol. 2019 Apr;61(4):406-418. doi: 10.1111/dmcn.14023. Epub 2018 Sep 19.
  PMID: 30230530
  responsible party type: Principal Investigator
  investigator affiliation: Uskudar University
  investigator full name: Dr. Öğr. Üyesi Ömer Şevgin
  investigator title: assistant professor
  mesh term: Learning Disabilities
  sharing ipd: No