<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/NCT03252444</url>
  </required_header>
  <id_info>
    <org_study_id>201412043RINA</org_study_id>
    <nct_id>NCT03252444</nct_id>
  </id_info>
  <brief_title>Therapeutic Approaches for Subjects With Scapula Dyskinesis</brief_title>
  <official_title>Therapeutic Approaches for Subjects With Scapula Dyskinesis: Conscious Control, EMG Biofeedback Training, and Intensive Scapula-focused Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</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>
      The investigators will test whether conscious control with manual guides and video or EMG&#xD;
      biofeedback will enhance 3-D kinematics of scapula in shoulder dysfunction subjects with&#xD;
      different type of scapula dyskinesis. The investigators will also examine how correction of&#xD;
      scapular orientation may affect the activation of associated muscles during various dynamic&#xD;
      movements in these subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 25, 2015</start_date>
  <completion_date type="Actual">May 21, 2017</completion_date>
  <primary_completion_date type="Actual">May 21, 2017</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Shoulder complex kinematics</measure>
    <time_frame>The scapular kinematics will be measured before scapular control and immediately after scapular control</time_frame>
    <description>Scapular orientation relative to the thorax is described using a Euler angle sequence of rotation about Zs (protraction/retraction), rotation about Y's (downward /upward rotation), and rotation about X&quot;s (posterior/anterior tipping). Scapular elevation is defined as the vertical displacement of the scapular sensor during arm elevation. Humeral orientation relative to the scapula is described using a Euler angle sequence in which the first rotation represents the plane of elevation, the second rotation defines the amount of elevation, and the third rotation describes the amount of axial rotation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Shoulder associated muscular activities</measure>
    <time_frame>The muscle activation will be measured before scapular control and immediately after scapular control</time_frame>
    <description>Full bandwidth sEMG data, captured by data acquisition software (AcqKnowledge, Biopac systems Inc., CA, USA)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Forward shoulder posture</measure>
    <time_frame>After subjects are included in the study, the forward shoulder posture will be measured before scapular control, and be done within 2 hours.</time_frame>
    <description>The measurement of the distance between the posterior border of the acromion and the table</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pectoralis minor muscle length</measure>
    <time_frame>After subjects are included in the study, the muscle length will be measured before scapular control, and be done within 2 hours.</time_frame>
    <description>The distance from the fourth rib to the coracoids process will be measured with FASTRAK system with accuracy of 0.08 cm. This distance (in centimeter) is divided by the subjects height and multiplied by 100. This results in a pectoralis muscle length index</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">139</enrollment>
  <condition>Shoulder Impingement</condition>
  <arm_group>
    <arm_group_label>Biofeedback group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After 1 minute of rest, participants will perform 6 trials of bilateral, active, weighted arm elevation in the scapular plane and a therapist classifies the scapular motion into specific patterns of scapular dyskinesis. After the evaluation of scapular dyskinesis, the kinematics and surface EMG (sEMG) data will be collected during 5 trials of the same arm movements and 3 selected exercises.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conscious control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conscious correction of scapular orientation will be taught to the subjects in the manner described in previous studies. The starting position is determined in each individual by actively positioning the scapula between maximal upward and downward rotation, external and internal rotation, and posterior and anterior tilt. Scapular assistance test (SAT) is also conducted by passively assisting patients' scapula into appropriate position to correct scapula dyskinesis</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conscious control</intervention_name>
    <description>Conscious control of the scapula is important and can correct neuromuscular coordination as well as strength deficits. The strategy in learning control of scapula into normal orientation can be facilitated by manual guides and/or external cues</description>
    <arm_group_label>Conscious control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conscious control+biofeedback</intervention_name>
    <description>In electromyography (EMG) biofeedback training, electronic equipment is used to reveal instantaneously certain physiological events.</description>
    <arm_group_label>Biofeedback group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  At least three positive of five tests, including Neer's test, Hawkin's test, Empty can&#xD;
             test, tenderness in tendon of rotator cuff and resisted external test.&#xD;
&#xD;
          -  Each patient will need a prescription of the physician or orthopedic surgeon for&#xD;
             diagnosing impingement symptoms&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        - Shoulder pain onset due to trauma, a history of shoulder fractures or dislocation,&#xD;
        cervical radiculopathy, degenerative joint disease of the shoulder, surgical interventions&#xD;
        on the shoulder, or inflammatory arthropathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jiu- Jenq Lin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>June 24, 2019</last_update_submitted>
  <last_update_submitted_qc>June 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Shoulder dyskinesis</keyword>
  <keyword>EMG biofeedback training</keyword>
  <keyword>Intensive Scapula-focused intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Impingement Syndrome</mesh_term>
    <mesh_term>Dyskinesias</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/NCT03252444
org study id: 201412043RINA
nct id: NCT03252444
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The investigators will test whether conscious control with manual guides and video or EMG
      biofeedback will enhance 3-D kinematics of scapula in shoulder dysfunction subjects with
      different type of scapula dyskinesis. The investigators will also examine how correction of
      scapular orientation may affect the activation of associated muscles during various dynamic
      movements in these subjects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Shoulder complex kinematics
time frame: The scapular kinematics will be measured before scapular control and immediately after scapular control
description: Scapular orientation relative to the thorax is described using a Euler angle sequence of rotation about Zs (protraction/retraction), rotation about Y's (downward /upward rotation), and rotation about X"s (posterior/anterior tipping). Scapular elevation is defined as the vertical displacement of the scapular sensor during arm elevation. Humeral orientation relative to the scapula is described using a Euler angle sequence in which the first rotation represents the plane of elevation, the second rotation defines the amount of elevation, and the third rotation describes the amount of axial rotation.
measure: Shoulder associated muscular activities
time frame: The muscle activation will be measured before scapular control and immediately after scapular control
description: Full bandwidth sEMG data, captured by data acquisition software (AcqKnowledge, Biopac systems Inc., CA, USA)
measure: Forward shoulder posture
time frame: After subjects are included in the study, the forward shoulder posture will be measured before scapular control, and be done within 2 hours.
description: The measurement of the distance between the posterior border of the acromion and the table
measure: Pectoralis minor muscle length
time frame: After subjects are included in the study, the muscle length will be measured before scapular control, and be done within 2 hours.
description: The distance from the fourth rib to the coracoids process will be measured with FASTRAK system with accuracy of 0.08 cm. This distance (in centimeter) is divided by the subjects height and multiplied by 100. This results in a pectoralis muscle length index
arm group label: Biofeedback group
arm group type: Experimental
description: After 1 minute of rest, participants will perform 6 trials of bilateral, active, weighted arm elevation in the scapular plane and a therapist classifies the scapular motion into specific patterns of scapular dyskinesis. After the evaluation of scapular dyskinesis, the kinematics and surface EMG (sEMG) data will be collected during 5 trials of the same arm movements and 3 selected exercises.
arm group label: Conscious control group
arm group type: Active Comparator
description: Conscious correction of scapular orientation will be taught to the subjects in the manner described in previous studies. The starting position is determined in each individual by actively positioning the scapula between maximal upward and downward rotation, external and internal rotation, and posterior and anterior tilt. Scapular assistance test (SAT) is also conducted by passively assisting patients' scapula into appropriate position to correct scapula dyskinesis
intervention type: Other
intervention name: Conscious control
description: Conscious control of the scapula is important and can correct neuromuscular coordination as well as strength deficits. The strategy in learning control of scapula into normal orientation can be facilitated by manual guides and/or external cues
arm group label: Conscious control group
intervention type: Other
intervention name: Conscious control+biofeedback
description: In electromyography (EMG) biofeedback training, electronic equipment is used to reveal instantaneously certain physiological events.
arm group label: Biofeedback group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Jiu- Jenq Lin, PhD
role: Principal Investigator
affiliation: National Taiwan University Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Shoulder Impingement Syndrome
mesh term: Dyskinesias