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/NCT05983887</url>
    </required_header>
    <id_info>
      <org_study_id>489/10-4-2023</org_study_id>
      <nct_id>NCT05983887</nct_id>
    </id_info>
    <brief_title>The Effect of Therapeutic Climbing on Muscle Strength, Tone and Balance in Hemiplegic Children</brief_title>
    <official_title>The Effect of Therapeutic Climbing on Muscle Strength, Tone and Balance in Hemiplegic Children: a Preliminary Single-blind Randomised Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Pavlos Kitixis</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Thessaly</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>
        The goal of this randomised controlled trial is to learn about the effect of therapeutic&#xD;
        climbing in hemiplegic children. The main questions it aims to answer are:&#xD;
  &#xD;
        Does climbing affect muscle strength and tone? What is its connection between normative data&#xD;
        drawn from healthy children? How can it affect balance?&#xD;
  &#xD;
        Participants (children) will be asked to complete an series of movements used in sports&#xD;
        climbing, such as inside-flag, back-flag and horizontal traverse, while hanging on an in-door&#xD;
        climbing wall.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">April 10, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 31, 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>
      <intervention_model_description>Single-blind Randomised Controlled Trial</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Muscle Strength</measure>
      <time_frame>8 weeks (pre-post evaluation)</time_frame>
      <description>Measured using Kinvent K-PUSH Dynamometer and Jamar Hydraulic Hand Dynamometer ; Unit of Measure: Peak Force in Kilograms</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Balance</measure>
      <time_frame>8 weeks (pre-post evaluation)</time_frame>
      <description>Measured using the Timed Up &amp; Go Test ; Unit of Measure: seconds of completion</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Muscle Tone</measure>
      <time_frame>8 weeks (pre-post evaluation)</time_frame>
      <description>Evaluated using the Modified Ashworth Scale ; Unit of Measure: Scoring Options (0-4)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Normative Strength Data Comparison</measure>
      <time_frame>8 weeks (pre-post evaluation)</time_frame>
      <description>Comparison of normative values of the Jamar Hydraulic Hand Dynamometer of Healthy and Hemiplegic Children ; Unit of Measure: Difference of Peak Force in Kilograms</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">12</enrollment>
    <condition>Hemiplegia and Hemiparesis</condition>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The participants in this group continue their conventional intervention protocol without using the climbing instructions.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Climbing Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The participants in this group continue their conventional intervention protocol plus an in-door climbing intervention protocol.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Therapeutic Climbing</intervention_name>
      <description>The protocol consists of using an in-door climbing wall as an complementary therapeutic intervention model.</description>
      <arm_group_label>Climbing Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Children from 4 to 16 years old&#xD;
  &#xD;
            -  Children with Hemiplegia&#xD;
  &#xD;
            -  Evaluated as Level 1 on GMFCS&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Botulinum toxin injection in last 6 months&#xD;
  &#xD;
            -  Surgery in the last 1 year (myofascial lengthening etc.)&#xD;
  &#xD;
            -  Children with poor cognitive skills (not following instructions etc.)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>4 Years</minimum_age>
      <maximum_age>16 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Thomas Besios, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>University of Thessaly</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Department of Physiotherapy</name>
        <address>
          <city>Lamía</city>
          <state>Phthiotis</state>
          <zip>35100</zip>
          <country>Greece</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Greece</country>
    </location_countries>
    <reference>
      <citation>Buechter RB, Fechtelpeter D. Climbing for preventing and treating health problems: a systematic review of randomized controlled trials. Ger Med Sci. 2011;9:Doc19. doi: 10.3205/000142. Epub 2011 Aug 9.</citation>
      <PMID>21863133</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 6, 2023</last_update_submitted>
    <last_update_submitted_qc>August 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>University of Thessaly</investigator_affiliation>
      <investigator_full_name>Pavlos Kitixis</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>therapeutic climbing</keyword>
    <keyword>hemiplegia</keyword>
    <keyword>children</keyword>
    <keyword>muscle strength</keyword>
    <keyword>balance</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hemiplegia</mesh_term>
      <mesh_term>Paresis</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/NCT05983887
  org study id: 489/10-4-2023
  nct id: NCT05983887
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this randomised controlled trial is to learn about the effect of therapeutic
        climbing in hemiplegic children. The main questions it aims to answer are:
  
        Does climbing affect muscle strength and tone? What is its connection between normative data
        drawn from healthy children? How can it affect balance?
  
        Participants (children) will be asked to complete an series of movements used in sports
        climbing, such as inside-flag, back-flag and horizontal traverse, while hanging on an in-door
        climbing wall.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Single-blind Randomised Controlled Trial
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Muscle Strength
  time frame: 8 weeks (pre-post evaluation)
  description: Measured using Kinvent K-PUSH Dynamometer and Jamar Hydraulic Hand Dynamometer ; Unit of Measure: Peak Force in Kilograms
  measure: Balance
  time frame: 8 weeks (pre-post evaluation)
  description: Measured using the Timed Up & Go Test ; Unit of Measure: seconds of completion
  measure: Muscle Tone
  time frame: 8 weeks (pre-post evaluation)
  description: Evaluated using the Modified Ashworth Scale ; Unit of Measure: Scoring Options (0-4)
  measure: Normative Strength Data Comparison
  time frame: 8 weeks (pre-post evaluation)
  description: Comparison of normative values of the Jamar Hydraulic Hand Dynamometer of Healthy and Hemiplegic Children ; Unit of Measure: Difference of Peak Force in Kilograms
  arm group label: Control Group
  arm group type: No Intervention
  description: The participants in this group continue their conventional intervention protocol without using the climbing instructions.
  arm group label: Climbing Group
  arm group type: Experimental
  description: The participants in this group continue their conventional intervention protocol plus an in-door climbing intervention protocol.
  intervention type: Other
  intervention name: Therapeutic Climbing
  description: The protocol consists of using an in-door climbing wall as an complementary therapeutic intervention model.
  arm group label: Climbing Group
  criteria: 
  gender: All
  minimum age: 4 Years
  maximum age: 16 Years
  healthy volunteers: No
  last name: Thomas Besios, PhD
  role: Study Chair
  affiliation: University of Thessaly
  facility: 
  country: Greece
  citation: Buechter RB, Fechtelpeter D. Climbing for preventing and treating health problems: a systematic review of randomized controlled trials. Ger Med Sci. 2011;9:Doc19. doi: 10.3205/000142. Epub 2011 Aug 9.
  PMID: 21863133
  responsible party type: Sponsor-Investigator
  investigator affiliation: University of Thessaly
  investigator full name: Pavlos Kitixis
  investigator title: Principal Investigator
  mesh term: Hemiplegia
  mesh term: Paresis
  sharing ipd: No