<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/NCT04438707</url>
  </required_header>
  <id_info>
    <org_study_id>CEUSP</org_study_id>
    <nct_id>NCT04438707</nct_id>
  </id_info>
  <brief_title>Pilates Method and Therapeutic Exercise in Children That Play String Instruments</brief_title>
  <official_title>Pilates Method and Therapeutic Exercise in Children That Play String Instruments: Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CEU San Pablo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CEU San Pablo University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Introduction: An inappropriate posture in children for a while kept playing some instrument&#xD;
      of the group of the rubbed string, can cause pain and alterations of the spine, as it&#xD;
      continues to consolidate.&#xD;
&#xD;
      Objective: To study the benefits acquired during the application of the Pilates Method&#xD;
      combined with therapeutic exercise against the Therapeutic Exercise to reduce alterations of&#xD;
      the vertebral rachis in children from 10 to 14 years old who play instruments of rubbed&#xD;
      strings.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Material and methods: A pilot study designed by a randomized controlled trial in two parallel&#xD;
      intervention groups was carried out; 9 children performed the combination of the Pilates&#xD;
      Method and Therapeutic Exercise (experimental) and 7 children performed the Therapeutic&#xD;
      Exercise (control). At the beginning and at the end of the study, pain measurements have been&#xD;
      made through the Visual Analogue Scale (EVA), and the Kinovea programme for the alignment of&#xD;
      shoulder, scapula and hip postures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 8, 2019</start_date>
  <completion_date type="Actual">September 25, 2020</completion_date>
  <primary_completion_date type="Actual">April 9, 2019</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>Pilot study designed by a randomized controlled trial in two parallel intervention groups</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>SVA</measure>
    <time_frame>4 weeks</time_frame>
    <description>to assess the pain in children. The child must choose a number (0-10) depending of the pain intensity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Kinovea tool</measure>
    <time_frame>4 weeks</time_frame>
    <description>to assess the alignement in shoulders, hips. It meusered in degrees of movement to observe the amplitud in the movemente and the simetry of joints. It is used a software to analyse the information and obtain the posture in the child.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Postural Kyphosis</condition>
  <condition>Postural Lordosis</condition>
  <condition>Postural Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pilates Method combined with Therapeutic exercice.</intervention_name>
    <description>Children must perform specific exercices in this combined method with the pilates principes (for back) during 50 min (1 day per week) for 4 weeks.</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Therapeutic exercise</intervention_name>
    <description>Children must perform specific exercices without the pilates principes (for back) during 50 min (1 day per week) for 4 weeks.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with typical development and ages between 10 and 14 years old.&#xD;
&#xD;
          -  Subjects who play the violin, viola, cello or double bass. Subjects who have learned&#xD;
             to play the violin, viola, cello or double bass in this school year or up to a maximum&#xD;
             of four previous years, eligible to receive Pilates classes.&#xD;
&#xD;
          -  Subjects with cognitive ability to understand simple orders.&#xD;
&#xD;
          -  Subjects who are enrolled this year in Orchestrated Neighborhoods.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects whose ages are not between 10 and 14 years of age.&#xD;
&#xD;
          -  Subjects who do not play the violin, viola, cello, or double bass.Subjects who have&#xD;
             more than four school years playing the violin, viola, cello or double bass.&#xD;
&#xD;
          -  Subjects who do not have cognitive capacity to understand simple orders.&#xD;
&#xD;
          -  Subjects who are not registered this year in Orchestrated Neighborhoods.&#xD;
&#xD;
          -  Subjects who do not complete the four sessions of Therapeutic Exercise + Pilates or&#xD;
             Therapeutic Exercise.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carolina Poncela, Therapyst</last_name>
    <role>Principal Investigator</role>
    <affiliation>CEU San Pablo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Carolina Poncela</name>
      <address>
        <city>Tenerife</city>
        <state>Santa Cruz De Tenerife</state>
        <zip>38111</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>January 25, 2021</last_update_submitted>
  <last_update_submitted_qc>January 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pilates</keyword>
  <keyword>Therapeutic Exercise</keyword>
  <keyword>Children</keyword>
  <keyword>String instruments</keyword>
  <keyword>Vertebral column</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kyphosis</mesh_term>
    <mesh_term>Lordosis</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>We will show the study protocol, de statistical resulst done with SPSS and the informed consent form.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>When the study is finished and all the data are analized by SPSS. It will be available for 6 months.</ipd_time_frame>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04438707
org study id: CEUSP
nct id: NCT04438707
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Introduction: An inappropriate posture in children for a while kept playing some instrument
      of the group of the rubbed string, can cause pain and alterations of the spine, as it
      continues to consolidate.

      Objective: To study the benefits acquired during the application of the Pilates Method
      combined with therapeutic exercise against the Therapeutic Exercise to reduce alterations of
      the vertebral rachis in children from 10 to 14 years old who play instruments of rubbed
      strings.
Material and methods: A pilot study designed by a randomized controlled trial in two parallel
      intervention groups was carried out; 9 children performed the combination of the Pilates
      Method and Therapeutic Exercise (experimental) and 7 children performed the Therapeutic
      Exercise (control). At the beginning and at the end of the study, pain measurements have been
      made through the Visual Analogue Scale (EVA), and the Kinovea programme for the alignment of
      shoulder, scapula and hip postures.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Pilot study designed by a randomized controlled trial in two parallel intervention groups
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
measure: SVA
time frame: 4 weeks
description: to assess the pain in children. The child must choose a number (0-10) depending of the pain intensity.
measure: Kinovea tool
time frame: 4 weeks
description: to assess the alignement in shoulders, hips. It meusered in degrees of movement to observe the amplitud in the movemente and the simetry of joints. It is used a software to analyse the information and obtain the posture in the child.
arm group label: Experimental group
arm group type: Experimental
arm group label: Control group
arm group type: Active Comparator
intervention type: Other
intervention name: Pilates Method combined with Therapeutic exercice.
description: Children must perform specific exercices in this combined method with the pilates principes (for back) during 50 min (1 day per week) for 4 weeks.
arm group label: Experimental group
intervention type: Other
intervention name: Therapeutic exercise
description: Children must perform specific exercices without the pilates principes (for back) during 50 min (1 day per week) for 4 weeks.
arm group label: Control group
criteria: 
gender: All
minimum age: 10 Years
maximum age: 14 Years
healthy volunteers: No
last name: Carolina Poncela, Therapyst
role: Principal Investigator
affiliation: CEU San Pablo University
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Kyphosis
mesh term: Lordosis
mesh term: Low Back Pain
sharing ipd: Yes
ipd description: We will show the study protocol, de statistical resulst done with SPSS and the informed consent form.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: When the study is finished and all the data are analized by SPSS. It will be available for 6 months.