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/NCT05999617</url>
    </required_header>
    <id_info>
      <org_study_id>CPdualtask</org_study_id>
      <nct_id>NCT05999617</nct_id>
    </id_info>
    <brief_title>Effectiveness of Dual Task Exercise Training in Children With Cerebral Palsy</brief_title>
    <official_title>The Effectiveness of Dual Task Exercise Training on Balance, Mobility, Physical Performance and Quality of Life in Children With Cerebral Palsy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Muğla Sıtkı Koçman University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Muğla Sıtkı Koçman 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>
        Cerebral palsy (CP) is the most common neurological disorder in children and one of the major&#xD;
        causes of motor disability. CP causes changes in postural and sensory integration, balance,&#xD;
        coordination disorders and muscle weakness due to problems in muscle tone. An effective&#xD;
        rehabilitation program is of great importance in solving many problems that can be associated&#xD;
        with decreased balance control. Researchers have stated that rehabilitation programs with&#xD;
        repetitive special tasks are effective. The aim of the study was to compare the effects of&#xD;
        conventional physiotherapy and dual task exercise training in addition to conventional&#xD;
        physiotherapy on balance, mobility, physical performance and quality of life in children with&#xD;
        cerebral palsy.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">May 12, 2023</start_date>
    <completion_date type="Actual">August 31, 2023</completion_date>
    <primary_completion_date type="Actual">August 21, 2023</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pediatric Balance Scale (PBS)</measure>
      <time_frame>Change from Baseline PBS at 12 weeks</time_frame>
      <description>The scale consists of 14 items measuring parameters such as sitting balance and standing balance. Each item is ranked from 0 to 4. 0 indicates that the instruction cannot be fulfilled, while 4 indicates that it can be fulfilled without any difficulty. The maximum total score is 56.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Timed Up and Go Test (TUG)</measure>
      <time_frame>Change from Baseline TUG at 12 weeks</time_frame>
      <description>Participants sit in a chair with arms, hips and knees bent approximately 90◦ and feet resting on the floor. Lower limb orthoses are worn if used. Participants are asked to stand up, walk 10 steps, walk around a mark on the floor, walk back to the chair and sit down. The timing of the TUG test starts with the standing movement after the &quot;ready, go&quot; signal and ends when the participants are seated in the chair and the movement is finished.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>One Leg Standing Test (OLST)</measure>
      <time_frame>Change from Baseline OLST at 12 weeks</time_frame>
      <description>Children are tested standing on one leg using their right and left leg respectively. The test is repeated on a hard surface with eyes open and closed. The child is asked to place both hands on the hips and look at a target on the wall at eye level at a distance of 1 meter. The child is asked to stand with one leg while keeping the other leg in a 90 degree flexion position. A stopwatch is used to record the time the child can hold the test position. The examiner ends the test if the child can hold the position for more than 30 seconds and records the elapsed time.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>3-Meter Backward Walk Test (3MBWT)</measure>
      <time_frame>Change from Baseline 3MBWT at 12 weeks</time_frame>
      <description>A distance of 3 m was measured and marked with black tape. Children were asked to follow the black tape with their heels. They were asked to walk backwards quickly with the command 'start'. When the 3 m distance was completed, they were asked to stop. The assessor walked behind the individuals throughout the test.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>6 Meter Walk Test (6MWT)</measure>
      <time_frame>Change from Baseline 6MWT at 12 weeks</time_frame>
      <description>A 6-meter track is determined. Children are asked to walk at a comfortable pace with the command &quot;Start&quot;. The stopwatch is stopped by touching the finish line.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Generic Children's Health-Related Quality of Life Questionnaire (KINDL)</measure>
      <time_frame>Change from Baseline KINDL at 12 weeks</time_frame>
      <description>The KINDL is a self-report questionnaire available for 3 different age groups: Kiddy-KINDL for children aged 4-7 years, Kid-KINDL for children aged 8-12 years and Kiddo-KINDL for adolescents aged 13-16 years. The total score ranges from 0-100. A higher score represents a better situation.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">30</enrollment>
    <condition>Cerebral Palsy</condition>
    <arm_group>
      <arm_group_label>Intervention Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Conventional rehabilitation (stretching, strengthening, balance) plus dual task exercise training (simple math during active stretching, carrying the ball without dropping child while on the balance pad) will be applied 3 days a week for 12 weeks. Interventions will be implemented individually. Patients will be evaluated before and 12 weeks after the interventions.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Conventional rehabilitation program (stretching, strengthening, balance) will be employed.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Rehabilitation</intervention_name>
      <description>Conventional rehabilitation (stretching, strengthening, balance) and dual task exercise training (simple math during active stretching, carrying the ball without dropping child while on the balance pad) will be applied 3 days a week for 12 weeks. Interventions will be implemented individually. Patients will be evaluated before and 12 weeks after the interventions.</description>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_label>Intervention Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Hemiplegic, monoplegic, unilaterally affected or diplegic children aged 5-12 years&#xD;
               with cerebral palsy&#xD;
  &#xD;
            -  Gross Motor Function Classification (GMFCS) level 1 (walks without restrictions) or 2&#xD;
               (walks with restrictions)&#xD;
  &#xD;
            -  Understand simple commands&#xD;
  &#xD;
            -  Signing the consent form&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Children and their families who do not want to be involved in the study&#xD;
  &#xD;
            -  Children with vision and hearing problems&#xD;
  &#xD;
            -  hildren with secondary orthopedic problems and children with walking aids&#xD;
  &#xD;
            -  Circumstances that would prevent carrying out assessments and exercise training or&#xD;
               communicating&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>5 Years</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>İsmail Uysal, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Muğla Sıtkı Koçman University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Fatih Özden, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Muğla Sıtkı Koçman University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>İsmet Tümtürk, MSc</last_name>
      <role>Principal Investigator</role>
      <affiliation>Süleyman Demirel University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Ahmet İmerci, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Muğla Sıtkı Koçman University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Fethiye Special Son Atilim Special Education and Rehabilitation Center</name>
        <address>
          <city>Muğla</city>
          <state>Fethiye</state>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Muğla Sıtkı Koçman University</investigator_affiliation>
      <investigator_full_name>Fatih Ozden</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>Cerebral Palsy</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/NCT05999617
  org study id: CPdualtask
  nct id: NCT05999617
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Cerebral palsy (CP) is the most common neurological disorder in children and one of the major
        causes of motor disability. CP causes changes in postural and sensory integration, balance,
        coordination disorders and muscle weakness due to problems in muscle tone. An effective
        rehabilitation program is of great importance in solving many problems that can be associated
        with decreased balance control. Researchers have stated that rehabilitation programs with
        repetitive special tasks are effective. The aim of the study was to compare the effects of
        conventional physiotherapy and dual task exercise training in addition to conventional
        physiotherapy on balance, mobility, physical performance and quality of life in children with
        cerebral palsy.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Pediatric Balance Scale (PBS)
  time frame: Change from Baseline PBS at 12 weeks
  description: The scale consists of 14 items measuring parameters such as sitting balance and standing balance. Each item is ranked from 0 to 4. 0 indicates that the instruction cannot be fulfilled, while 4 indicates that it can be fulfilled without any difficulty. The maximum total score is 56.
  measure: Timed Up and Go Test (TUG)
  time frame: Change from Baseline TUG at 12 weeks
  description: Participants sit in a chair with arms, hips and knees bent approximately 90◦ and feet resting on the floor. Lower limb orthoses are worn if used. Participants are asked to stand up, walk 10 steps, walk around a mark on the floor, walk back to the chair and sit down. The timing of the TUG test starts with the standing movement after the "ready, go" signal and ends when the participants are seated in the chair and the movement is finished.
  measure: One Leg Standing Test (OLST)
  time frame: Change from Baseline OLST at 12 weeks
  description: Children are tested standing on one leg using their right and left leg respectively. The test is repeated on a hard surface with eyes open and closed. The child is asked to place both hands on the hips and look at a target on the wall at eye level at a distance of 1 meter. The child is asked to stand with one leg while keeping the other leg in a 90 degree flexion position. A stopwatch is used to record the time the child can hold the test position. The examiner ends the test if the child can hold the position for more than 30 seconds and records the elapsed time.
  measure: 3-Meter Backward Walk Test (3MBWT)
  time frame: Change from Baseline 3MBWT at 12 weeks
  description: A distance of 3 m was measured and marked with black tape. Children were asked to follow the black tape with their heels. They were asked to walk backwards quickly with the command 'start'. When the 3 m distance was completed, they were asked to stop. The assessor walked behind the individuals throughout the test.
  measure: 6 Meter Walk Test (6MWT)
  time frame: Change from Baseline 6MWT at 12 weeks
  description: A 6-meter track is determined. Children are asked to walk at a comfortable pace with the command "Start". The stopwatch is stopped by touching the finish line.
  measure: The Generic Children's Health-Related Quality of Life Questionnaire (KINDL)
  time frame: Change from Baseline KINDL at 12 weeks
  description: The KINDL is a self-report questionnaire available for 3 different age groups: Kiddy-KINDL for children aged 4-7 years, Kid-KINDL for children aged 8-12 years and Kiddo-KINDL for adolescents aged 13-16 years. The total score ranges from 0-100. A higher score represents a better situation.
  arm group label: Intervention Group
  arm group type: Experimental
  description: Conventional rehabilitation (stretching, strengthening, balance) plus dual task exercise training (simple math during active stretching, carrying the ball without dropping child while on the balance pad) will be applied 3 days a week for 12 weeks. Interventions will be implemented individually. Patients will be evaluated before and 12 weeks after the interventions.
  arm group label: Control Group
  arm group type: Active Comparator
  description: Conventional rehabilitation program (stretching, strengthening, balance) will be employed.
  intervention type: Other
  intervention name: Rehabilitation
  description: Conventional rehabilitation (stretching, strengthening, balance) and dual task exercise training (simple math during active stretching, carrying the ball without dropping child while on the balance pad) will be applied 3 days a week for 12 weeks. Interventions will be implemented individually. Patients will be evaluated before and 12 weeks after the interventions.
  arm group label: Control Group
  arm group label: Intervention Group
  criteria: 
  gender: All
  minimum age: 5 Years
  maximum age: 12 Years
  healthy volunteers: No
  last name: İsmail Uysal, PhD
  role: Study Director
  affiliation: Muğla Sıtkı Koçman University
  last name: Fatih Özden, PhD
  role: Principal Investigator
  affiliation: Muğla Sıtkı Koçman University
  last name: İsmet Tümtürk, MSc
  role: Principal Investigator
  affiliation: Süleyman Demirel University
  last name: Ahmet İmerci, MD
  role: Principal Investigator
  affiliation: Muğla Sıtkı Koçman University
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Muğla Sıtkı Koçman University
  investigator full name: Fatih Ozden
  investigator title: Assistant Professor
  mesh term: Cerebral Palsy
  sharing ipd: No