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/NCT06036069</url>
    </required_header>
    <id_info>
      <org_study_id>P.T.REC/012/004335</org_study_id>
      <nct_id>NCT06036069</nct_id>
    </id_info>
    <brief_title>Improvement of Whole Body Vibration and Core Stability Exercises on Muscle Strength in Down Syndrome Children</brief_title>
    <official_title>Effect of Whole Body Vibration Versus Core Stability Exercises on Balance and Muscle Strength in Children With Down Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ragaee Saeed Mahmoud</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>South Valley 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>
        Children had Down syndrome often have impaired balance and postural control and result as&#xD;
        less active than their peers that can lead to reduced quality of life and movement skills.&#xD;
        Effects of physical activity may be important in preventing falling risk and health&#xD;
        consequences in those children&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Sixty children from both genders (boys and girls) participated in this study, their ages&#xD;
        ranged from 10 to 16 years and they were randomized into three groups of same number (A, B&#xD;
        and C). Groups (A) received conventional physical therapy program, group (B) received the&#xD;
        same conventional physical therapy program of group (A) and core stability exercises while&#xD;
        group (C) received the same conventional physical therapy program of group (A and B) and&#xD;
        whole body vibration exercise&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 15, 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>Randomized control study</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>Single (outcomes Assessor)</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Biodex Balance System</measure>
      <time_frame>before intervention and after 12 weeks of intervention</time_frame>
      <description>it is a reliable and objective assessment in order to quantify dynamic balance</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Hand-held dynamometer</measure>
      <time_frame>before intervention and after 12 weeks of intervention</time_frame>
      <description>It is a portable device (Nicholas Manual Muscle Tester, Model 01160; Lafayette Instrument, Lafayette, IN), characterized as low-cost and convenient method</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Down Syndrome</condition>
    <arm_group>
      <arm_group_label>Conventional physical therapy group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>It consisted of 20 children received conventional physical therapy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Core stability exercises group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>It consisted of 20 children received conventional physical therapy and core stability exercises</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Whole body vibration</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>It consisted of 20 children received conventional physical therapy and whole body vibration exercises</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Conventional physical therapy</intervention_name>
      <description>Standing with feet together while the therapist was sitting behind and manually locking the child knees.&#xD;
  Step standing with the therapist behind the child.&#xD;
  High step standing and trying to keep balanced. The child stood on exercise mattress.&#xD;
  Single leg stance &quot;unilateral standing&quot; with assistance. The child was standing on exercise mattress.&#xD;
  Standing on a declined surface by using wedge. The child was standing on wedge towards the descending direction.&#xD;
  Standing with manual locking of the knees.&#xD;
  Changing position.&#xD;
  Gait training.&#xD;
  Static and dynamic muscle contraction.</description>
      <arm_group_label>Conventional physical therapy group</arm_group_label>
      <arm_group_label>Core stability exercises group</arm_group_label>
      <arm_group_label>Whole body vibration</arm_group_label>
      <other_name>Physical therapy program</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Aged between 10 to 16 years.&#xD;
  &#xD;
            -  Able to recognize commands given to them.&#xD;
  &#xD;
            -  Understand our verbal command and encouragement.&#xD;
  &#xD;
            -  Stand and walk independently without repeated falling.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Children with any neurological (signs of epilepsy and instability of atlantoaxial&#xD;
               joint).&#xD;
  &#xD;
            -  Musculoskeletal, or mobility disorders.&#xD;
  &#xD;
            -  Cardiac anomalies.&#xD;
  &#xD;
            -  Vision or hearing loss.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>10 Years</minimum_age>
      <maximum_age>16 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Ragaee Saeed Mahmoud</name>
        <address>
          <city>Giza</city>
          <state>Faisal</state>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ragaee Mahmoud</last_name>
        <phone>00201223611112</phone>
        <email>ragaeesaeedpt10@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Reham Mahmoud</last_name>
        <phone>00201015447798</phone>
        <email>rsm_211pt@yahoo.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 2, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>South Valley University</investigator_affiliation>
      <investigator_full_name>Ragaee Saeed Mahmoud</investigator_full_name>
      <investigator_title>Lecturer</investigator_title>
    </responsible_party>
    <keyword>Children; Core Stability Exercises; Down Syndrome; Whole Body Vibration</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Down Syndrome</mesh_term>
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_info_type>Study Protocol</ipd_info_type>
    </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/NCT06036069
  org study id: P.T.REC/012/004335
  nct id: NCT06036069
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Children had Down syndrome often have impaired balance and postural control and result as
        less active than their peers that can lead to reduced quality of life and movement skills.
        Effects of physical activity may be important in preventing falling risk and health
        consequences in those children
  Sixty children from both genders (boys and girls) participated in this study, their ages
        ranged from 10 to 16 years and they were randomized into three groups of same number (A, B
        and C). Groups (A) received conventional physical therapy program, group (B) received the
        same conventional physical therapy program of group (A) and core stability exercises while
        group (C) received the same conventional physical therapy program of group (A and B) and
        whole body vibration exercise
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized control study
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: Single (outcomes Assessor)
  measure: Biodex Balance System
  time frame: before intervention and after 12 weeks of intervention
  description: it is a reliable and objective assessment in order to quantify dynamic balance
  measure: Hand-held dynamometer
  time frame: before intervention and after 12 weeks of intervention
  description: It is a portable device (Nicholas Manual Muscle Tester, Model 01160; Lafayette Instrument, Lafayette, IN), characterized as low-cost and convenient method
  arm group label: Conventional physical therapy group
  arm group type: Experimental
  description: It consisted of 20 children received conventional physical therapy
  arm group label: Core stability exercises group
  arm group type: Experimental
  description: It consisted of 20 children received conventional physical therapy and core stability exercises
  arm group label: Whole body vibration
  arm group type: Experimental
  description: It consisted of 20 children received conventional physical therapy and whole body vibration exercises
  intervention type: Other
  intervention name: Conventional physical therapy
  description: Standing with feet together while the therapist was sitting behind and manually locking the child knees.
  Step standing with the therapist behind the child.
  High step standing and trying to keep balanced. The child stood on exercise mattress.
  Single leg stance "unilateral standing" with assistance. The child was standing on exercise mattress.
  Standing on a declined surface by using wedge. The child was standing on wedge towards the descending direction.
  Standing with manual locking of the knees.
  Changing position.
  Gait training.
  Static and dynamic muscle contraction.
  arm group label: Conventional physical therapy group
  arm group label: Core stability exercises group
  arm group label: Whole body vibration
  other name: Physical therapy program
  criteria: 
  gender: All
  minimum age: 10 Years
  maximum age: 16 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Egypt
  responsible party type: Sponsor-Investigator
  investigator affiliation: South Valley University
  investigator full name: Ragaee Saeed Mahmoud
  investigator title: Lecturer
  mesh term: Down Syndrome
  mesh term: Syndrome
  sharing ipd: Yes
  ipd info type: Study Protocol