<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/NCT04476004</url>
  </required_header>
  <id_info>
    <org_study_id>201901788A3</org_study_id>
    <nct_id>NCT04476004</nct_id>
  </id_info>
  <brief_title>Effects of Electromyographic Visual Feedback for Spinal Accessory Nerve Dysfunction After Neck Dissection</brief_title>
  <official_title>Effects of Electromyographic Visual Feedback for Spinal Accessory Nerve Dysfunction in Oral Cancer Survivors With Neck Dissection: a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</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>
      Patients with head and neck cancer and undergo neck dissection often suffer from spinal&#xD;
      accessory nerve dysfunction (e.g. shoulder droop, shoulder pain, and decreased active range&#xD;
      of motion (AROM) of the shoulder joint and scapular muscle strength), even the spinal&#xD;
      accessory nerve is preserved during surgery. Abnormal muscle activities of scapular muscles,&#xD;
      including upper trapezius (UT), middle trapezius (MT), lower trapezius (LT), serratus&#xD;
      anterior (SA) and rhomboid were reported in subsequent research articles. Particularly for&#xD;
      the trapezius muscle, the decreased amplitudes were observed even after 9 months of neck&#xD;
      dissection. It has been reported that conscious correction of scapular orientation during arm&#xD;
      movement could increase trapezius muscle activities, and motor control training could change&#xD;
      scapular kinematic such as increased posterior tilt and upward rotation during arm movement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with head and neck cancer and undergo neck dissection often suffer from spinal&#xD;
      accessory nerve dysfunction (e.g. shoulder droop, shoulder pain, and decreased active range&#xD;
      of motion (AROM) of the shoulder joint and scapular muscle strength), even the spinal&#xD;
      accessory nerve is preserved during surgery. Abnormal muscle activities of scapular muscles,&#xD;
      including upper trapezius (UT), middle trapezius (MT), lower trapezius (LT), serratus&#xD;
      anterior (SA) and rhomboid were reported in subsequent research articles. Particularly for&#xD;
      the trapezius muscle, the decreased amplitudes were observed even after 9 months of neck&#xD;
      dissection. It has been reported that conscious correction of scapular orientation during arm&#xD;
      movement could increase trapezius muscle activities, and motor control training could change&#xD;
      scapular kinematic such as increased posterior tilt and upward rotation during arm movement.&#xD;
&#xD;
      The aim of this study is to explore the effects of electromyographic (EMG) visual feedback on&#xD;
      scapular muscle activities and strength in oral cancer survivors with spinal accessory nerve&#xD;
      dysfunction. Investigators will recruit 60 newly diagnosed oral cancer subjects through the&#xD;
      plastic surgeon's referral from January 2020 to February 2021. The participants will be&#xD;
      randomized separated into experimental or control group. Each group would receive regular&#xD;
      physical therapy for shoulder function (e.g. transcutaneous electrical stimulation, shoulder&#xD;
      joint range of motion exercise) and scapular-focused exercise. EMG visual feedback would be&#xD;
      combined with scapular-focused exercise.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2020</start_date>
  <completion_date type="Actual">February 28, 2021</completion_date>
  <primary_completion_date type="Actual">February 28, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>shoulder pain</measure>
    <time_frame>0, 3 months</time_frame>
    <description>Visual Analog Scale, total range=0-10, 0 means no pain and 10 means the obvious pain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>shoulder joint range of motion</measure>
    <time_frame>0, 3 months</time_frame>
    <description>abduction measured by goniometer, total range: 0-180</description>
  </primary_outcome>
  <primary_outcome>
    <measure>scapular position</measure>
    <time_frame>0, 3 months</time_frame>
    <description>Modified Lateral Scapular Slide Test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>quality of life C-30</measure>
    <time_frame>0, 3 months</time_frame>
    <description>European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30, total range= 0-100. A higher score on the functional scale or global health scale represents a higher level of functioning or quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>shoulder function</measure>
    <time_frame>3 months</time_frame>
    <description>The Disabilities of the Arm, Shoulder and Hand (DASH) Score, total range: 0-100. Higher scores indicate greater disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>muscle activity to perform arm movement</measure>
    <time_frame>3 months</time_frame>
    <description>EMG activities measure the muscle activities of the upper trapezius, middle trapezius, and lower trapezius</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>maximal isometric muscle strength (MVIC)</measure>
    <time_frame>3 months</time_frame>
    <description>measurement of MVIC of the upper trapezius, middle trapezius, and lower trapezius</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EMG activities of maximal isometric muscle strength (MVIC)</measure>
    <time_frame>3 months</time_frame>
    <description>measurement of surface EMG activities of the upper trapezius, middle trapezius, and lower trapezius during MVIC</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Oral Cancer</condition>
  <arm_group>
    <arm_group_label>experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>EMG group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>exercise group</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>scapular-focused exercise</intervention_name>
    <description>scapular-focused exercise</description>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>visual feedback</intervention_name>
    <description>EMG visual feedback</description>
    <arm_group_label>experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  newly diagnosed oral cancer subjects with neck dissection&#xD;
&#xD;
          -  age between 20 and 65 years&#xD;
&#xD;
          -  having the clinical signs of neck-dissection related shoulder dysfunction (e.g.&#xD;
             shoulder droop, limited AROM of shoulder abduction, and insufficient muscle strength&#xD;
             of shoulder abduction to against gravity)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  were pregnant or breastfeeding&#xD;
&#xD;
          -  had distant metastasis or recurrence&#xD;
&#xD;
          -  were unable to communicate or comprehend the questionnaires&#xD;
&#xD;
          -  had a history of shoulder dysfunction before neck dissection (e.g. shoulder pain,&#xD;
             tendinitis, tendon rupture, shoulder capsulitis, or neuropathy)&#xD;
&#xD;
          -  had any disorder that could influence movement performance&#xD;
&#xD;
          -  bilateral neck dissection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yueh-Hsia Chen, Master</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Plastic and Reconstructive Surgery Rehabilitation Center, Chung Gung Memorial Hospital</name>
      <address>
        <city>Taoyuan</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
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    <citation>De Mey K, Danneels LA, Cagnie B, Huyghe L, Seyns E, Cools AM. Conscious correction of scapular orientation in overhead athletes performing selected shoulder rehabilitation exercises: the effect on trapezius muscle activation measured by surface electromyography. J Orthop Sports Phys Ther. 2013 Jan;43(1):3-10. doi: 10.2519/jospt.2013.4283. Epub 2012 Nov 16.</citation>
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  <verification_date>October 2020</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>July 29, 2021</last_update_submitted>
  <last_update_submitted_qc>July 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Scapular-focused exercise</keyword>
  <keyword>Scapular Dyskinesis</keyword>
  <keyword>Spinal accessory nerve</keyword>
  <keyword>Physical therapy</keyword>
  <keyword>Electromyography</keyword>
  <keyword>Visual feedback</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mouth Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT04476004
org study id: 201901788A3
nct id: NCT04476004
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Patients with head and neck cancer and undergo neck dissection often suffer from spinal
      accessory nerve dysfunction (e.g. shoulder droop, shoulder pain, and decreased active range
      of motion (AROM) of the shoulder joint and scapular muscle strength), even the spinal
      accessory nerve is preserved during surgery. Abnormal muscle activities of scapular muscles,
      including upper trapezius (UT), middle trapezius (MT), lower trapezius (LT), serratus
      anterior (SA) and rhomboid were reported in subsequent research articles. Particularly for
      the trapezius muscle, the decreased amplitudes were observed even after 9 months of neck
      dissection. It has been reported that conscious correction of scapular orientation during arm
      movement could increase trapezius muscle activities, and motor control training could change
      scapular kinematic such as increased posterior tilt and upward rotation during arm movement.
Patients with head and neck cancer and undergo neck dissection often suffer from spinal
      accessory nerve dysfunction (e.g. shoulder droop, shoulder pain, and decreased active range
      of motion (AROM) of the shoulder joint and scapular muscle strength), even the spinal
      accessory nerve is preserved during surgery. Abnormal muscle activities of scapular muscles,
      including upper trapezius (UT), middle trapezius (MT), lower trapezius (LT), serratus
      anterior (SA) and rhomboid were reported in subsequent research articles. Particularly for
      the trapezius muscle, the decreased amplitudes were observed even after 9 months of neck
      dissection. It has been reported that conscious correction of scapular orientation during arm
      movement could increase trapezius muscle activities, and motor control training could change
      scapular kinematic such as increased posterior tilt and upward rotation during arm movement.

      The aim of this study is to explore the effects of electromyographic (EMG) visual feedback on
      scapular muscle activities and strength in oral cancer survivors with spinal accessory nerve
      dysfunction. Investigators will recruit 60 newly diagnosed oral cancer subjects through the
      plastic surgeon's referral from January 2020 to February 2021. The participants will be
      randomized separated into experimental or control group. Each group would receive regular
      physical therapy for shoulder function (e.g. transcutaneous electrical stimulation, shoulder
      joint range of motion exercise) and scapular-focused exercise. EMG visual feedback would be
      combined with scapular-focused exercise.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: shoulder pain
time frame: 0, 3 months
description: Visual Analog Scale, total range=0-10, 0 means no pain and 10 means the obvious pain
measure: shoulder joint range of motion
time frame: 0, 3 months
description: abduction measured by goniometer, total range: 0-180
measure: scapular position
time frame: 0, 3 months
description: Modified Lateral Scapular Slide Test
measure: quality of life C-30
time frame: 0, 3 months
description: European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30, total range= 0-100. A higher score on the functional scale or global health scale represents a higher level of functioning or quality of life.
measure: shoulder function
time frame: 3 months
description: The Disabilities of the Arm, Shoulder and Hand (DASH) Score, total range: 0-100. Higher scores indicate greater disability.
measure: muscle activity to perform arm movement
time frame: 3 months
description: EMG activities measure the muscle activities of the upper trapezius, middle trapezius, and lower trapezius
measure: maximal isometric muscle strength (MVIC)
time frame: 3 months
description: measurement of MVIC of the upper trapezius, middle trapezius, and lower trapezius
measure: EMG activities of maximal isometric muscle strength (MVIC)
time frame: 3 months
description: measurement of surface EMG activities of the upper trapezius, middle trapezius, and lower trapezius during MVIC
arm group label: experimental group
arm group type: Experimental
description: EMG group
arm group label: control group
arm group type: Active Comparator
description: exercise group
intervention type: Other
intervention name: scapular-focused exercise
description: scapular-focused exercise
arm group label: control group
arm group label: experimental group
intervention type: Other
intervention name: visual feedback
description: EMG visual feedback
arm group label: experimental group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Yueh-Hsia Chen, Master
role: Principal Investigator
affiliation: Chang Gung Memorial Hospital
facility: 
country: Taiwan
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responsible party type: Sponsor
mesh term: Mouth Neoplasms