<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/NCT04432441</url>
  </required_header>
  <id_info>
    <org_study_id>19741974</org_study_id>
    <nct_id>NCT04432441</nct_id>
  </id_info>
  <brief_title>Effects of Neuromuscular Electrostimulation on Scapular Stability</brief_title>
  <official_title>Effects of Neuromuscular Electrical Stimulation (NMES) Plus Therapeutic Exercise Combination on Scapular Stability in Female Professional Handball Players With Scapular Dyskinesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Extremadura</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Luis Espejo Antúnez</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Antoni Morral</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Extremadura</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>
      Injuries and shoulder pain are common problems in handball, more often among female athletes.&#xD;
      The impact on performance and participation shows the need to work on the risk factors to&#xD;
      minimize the damage. It has been found an association between scapular dysfunction and pain&#xD;
      in the shoulder. Currently there are many exercise programs, but few with electrotherapy&#xD;
      implemented. The aim of the study is to assess the effect of a therapeutic physical exercise&#xD;
      program for scapulo-humeral stabilitation with and without electrotherapy on scapular&#xD;
      stability, glenohumeral internal rotation and external rotation strength.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2021</start_date>
  <completion_date type="Actual">June 11, 2021</completion_date>
  <primary_completion_date type="Actual">February 16, 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>Two groups. Experimental group realizes a therapeutic physical exercise program for scapulo-humeral stabilitation, and the other group (control group) the same program with electrostimulation. The programme consisted of a two-part sequence of isometric prone push-up, being it an optimal position for periscapular stability exercises.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Scapular Static Positioning Assessment: Upper distance</measure>
    <time_frame>Changes from baseline after a month</time_frame>
    <description>cm</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Scapular Static Positioning Assessment: Lower distance</measure>
    <time_frame>Changes from baseline after a month</time_frame>
    <description>cm</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>RI Range of movement</measure>
    <time_frame>Changes from baseline after a month</time_frame>
    <description>Degrees</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>External rotation strenght</measure>
    <time_frame>Changes from baseline after a month</time_frame>
    <description>kg</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Adult Female Handball Player</condition>
  <arm_group>
    <arm_group_label>Therapeutic physical exercise program for scapulo-humeral stabilitation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Therapeutic physical exercise program for scapulo-humeral stabilitation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Therapeutic physical exercise program for scapulo-humeral stabilitation + Electrostimulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Therapeutic physical exercise program for scapulo-humeral stabilitation + Electrostimulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Therapeutic physical exercise program for scapulo-humeral stabilitation</intervention_name>
    <description>This group realize a therapeutic physical exercise program for scapulo-humeral stabilitation during a month</description>
    <arm_group_label>Therapeutic physical exercise program for scapulo-humeral stabilitation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Therapeutic physical exercise program for scapulo-humeral stabilitation + electrostimulation</intervention_name>
    <description>This group realize a therapeutic physical exercise program for scapulo-humeral stabilitation added electrostimulation during a month</description>
    <arm_group_label>Therapeutic physical exercise program for scapulo-humeral stabilitation + Electrostimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  To have more than 18 YO&#xD;
&#xD;
          -  To be female&#xD;
&#xD;
          -  To do at least 5 hour of sport training per week in last two years&#xD;
&#xD;
          -  To be part of federated club that allows them in their weekly practice to participate&#xD;
             in recreational matches or small local championship during weekends.&#xD;
&#xD;
          -  To have scapular diskinesis by McClure scale&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  To have an actual injury&#xD;
&#xD;
          -  To have an history of injury in last 12 months&#xD;
&#xD;
          -  To take drugs that can affect to control motor.&#xD;
&#xD;
          -  To be part or participate in a control motor program or specific prevention program&#xD;
&#xD;
          -  To have a recent surgery in last year in upper or back.&#xD;
&#xD;
          -  A score below 45 points on the Personal Psychological Apprehension Scale.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Universidad de Extremadura</name>
      <address>
        <city>Badajoz</city>
        <zip>06071</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>November 8, 2021</last_update_submitted>
  <last_update_submitted_qc>November 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Extremadura</investigator_affiliation>
    <investigator_full_name>Javier Gutiérrez Coronado</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>&quot;Electric Stimulation Therapy&quot;</keyword>
  <keyword>&quot;Resistance training&quot;</keyword>
  <keyword>&quot;Overhead sports&quot;</keyword>
  <keyword>&quot;Risk factors&quot;</keyword>
  <keyword>&quot;Scapular anomalies&quot;</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04432441
org study id: 19741974
nct id: NCT04432441
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Injuries and shoulder pain are common problems in handball, more often among female athletes.
      The impact on performance and participation shows the need to work on the risk factors to
      minimize the damage. It has been found an association between scapular dysfunction and pain
      in the shoulder. Currently there are many exercise programs, but few with electrotherapy
      implemented. The aim of the study is to assess the effect of a therapeutic physical exercise
      program for scapulo-humeral stabilitation with and without electrotherapy on scapular
      stability, glenohumeral internal rotation and external rotation strength.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Two groups. Experimental group realizes a therapeutic physical exercise program for scapulo-humeral stabilitation, and the other group (control group) the same program with electrostimulation. The programme consisted of a two-part sequence of isometric prone push-up, being it an optimal position for periscapular stability exercises.
primary purpose: Prevention
masking: None (Open Label)
measure: Scapular Static Positioning Assessment: Upper distance
time frame: Changes from baseline after a month
description: cm
measure: Scapular Static Positioning Assessment: Lower distance
time frame: Changes from baseline after a month
description: cm
measure: RI Range of movement
time frame: Changes from baseline after a month
description: Degrees
measure: External rotation strenght
time frame: Changes from baseline after a month
description: kg
arm group label: Therapeutic physical exercise program for scapulo-humeral stabilitation
arm group type: Active Comparator
description: Therapeutic physical exercise program for scapulo-humeral stabilitation
arm group label: Therapeutic physical exercise program for scapulo-humeral stabilitation + Electrostimulation
arm group type: Active Comparator
description: Therapeutic physical exercise program for scapulo-humeral stabilitation + Electrostimulation
intervention type: Other
intervention name: Therapeutic physical exercise program for scapulo-humeral stabilitation
description: This group realize a therapeutic physical exercise program for scapulo-humeral stabilitation during a month
arm group label: Therapeutic physical exercise program for scapulo-humeral stabilitation
intervention type: Other
intervention name: Therapeutic physical exercise program for scapulo-humeral stabilitation + electrostimulation
description: This group realize a therapeutic physical exercise program for scapulo-humeral stabilitation added electrostimulation during a month
arm group label: Therapeutic physical exercise program for scapulo-humeral stabilitation + Electrostimulation
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Extremadura
investigator full name: Javier Gutiérrez Coronado
investigator title: Principal Investigator
sharing ipd: No