<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/NCT04413162</url>
  </required_header>
  <id_info>
    <org_study_id>1490166</org_study_id>
    <nct_id>NCT04413162</nct_id>
  </id_info>
  <brief_title>Using Kinect Motion Capture to Measure Shoulder Motion in Patients Undergoing Capsular Distension for Adhesive Capsulitis</brief_title>
  <official_title>Measurement of Shoulder Range of Motion Using Microsoft Kinect 2.0 in Patients Undergoing Ultrasound-guided Capsular Distension for Adhesive Capsulitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Davis</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>
      This study will compare shoulder range of motion assessment using the Kinect motion tracking&#xD;
      system vs goniometer in patients with adhesive capsulitis (frozen shoulder) undergoing&#xD;
      ultrasound-guided capsular distention procedures (standard of care).&#xD;
&#xD;
      The investigators hypothesize that, for shoulder adhesive capsulitis, the Kinect Motion&#xD;
      Analysis 2.0 system will provide reliable results in a shorter and more efficient amount of&#xD;
      time in comparison to traditional goniometer methods.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be a single-center, investigator-initiated protocol to assess the reliability&#xD;
      of the Kinect Motion Analysis 2.0 Motion Tracking System for Range Of Motion (ROM) assessment&#xD;
      in patients with Shoulder Adhesive Capsulitis undergoing ultrasound guided capsular&#xD;
      distention procedures (standard of care for adhesive capsulitis). Secondarily, the study will&#xD;
      describe the relationship between range of motion of the shoulder girdle in the four&#xD;
      quadrants of normalized reachable workspace by the Kinect 2.0, PROMIS person-reported outcome&#xD;
      scores for pain, pain interference and function (general mobility and upper extremity&#xD;
      function), and VAS pain scores.&#xD;
&#xD;
      Study participants are anticipated to remain in the study for 12 weeks: an initial visit&#xD;
      followed by 6- and 12-week follow up visits. Given the nature of scheduling appointments in&#xD;
      medical clinics, 12 weeks is an approximation; the actual duration may occasionally be 1-2&#xD;
      weeks longer if needed to successfully complete the follow-up visit.&#xD;
&#xD;
      The investigators hypothesize that, for shoulder adhesive capsulitis, the Kinect Motion&#xD;
      Analysis 2.0 system will provide reliable results in a shorter and more efficient amount of&#xD;
      time in comparison to traditional goniometer methods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 10, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in shoulder range of motion</measure>
    <time_frame>12 weeks</time_frame>
    <description>measured in degrees (high number of degrees = better range of motion)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PROMIS score - upper extremity</measure>
    <time_frame>12 weeks</time_frame>
    <description>Patient-Reported Outcomes Measurement Information System (PROMIS) is a validated, 46-item, self-reported system to assess physical function and symptoms in patients with disorders of the limb. Range of possible values: 46-230. (Higher score indicates higher function and outcomes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DASH score</measure>
    <time_frame>12 weeks</time_frame>
    <description>The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 38-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. Range of possible values: 38-150. (Lower score indicates better function / less disability)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS score</measure>
    <time_frame>12 weeks</time_frame>
    <description>Visual analog scale is a validated, subjective measure for pain. Range of possible values: 0-10. (Higher score indicates more pain)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Adhesive Capsulitis</condition>
  <condition>Adhesive Capsulitis of Shoulder</condition>
  <condition>Frozen Shoulder</condition>
  <condition>Shoulder Frozen</condition>
  <condition>Shoulder Pain</condition>
  <condition>Mobility Limitation</condition>
  <arm_group>
    <arm_group_label>measurement before and after capsular distention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Kinect motion tracking system</intervention_name>
    <description>Kinect motion tracking system is used to measure shoulder range of motion compared to goniometric measurement.</description>
    <arm_group_label>measurement before and after capsular distention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. diagnosis of limited ROM due to adhesive capsulitis&#xD;
&#xD;
          2. duration of symptoms of ≥ 3 months&#xD;
&#xD;
          3. persistent functional limitation (defined as either limitations occupationally, in&#xD;
             independent activities of daily living, or activities of daily living)&#xD;
&#xD;
          4. X-rays and MRI excluding alternative diagnosis&#xD;
&#xD;
          5. age 18 years or older.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. prior shoulder surgery on the affected side&#xD;
&#xD;
          2. complete rotator cuff tear (based on clinical history, examination, and imaging) or&#xD;
             planned surgical intervention on the affected side&#xD;
&#xD;
          3. ipsilateral subacromial injection within the last 3 months&#xD;
&#xD;
          4. autoimmune or rheumatologic disease affecting the joints&#xD;
&#xD;
          5. lack of scheduled same-day physical therapy appointment&#xD;
&#xD;
          6. inability to complete follow-up appointments or surveys&#xD;
&#xD;
          7. inability to provide informed consent&#xD;
&#xD;
          8. symptomatic glenohumeral or acromioclavicular pathology&#xD;
&#xD;
          9. referred pain from the neck or internal organs&#xD;
&#xD;
         10. generalized myofascial pain syndrome&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kevin Mullins, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UC Davis Health</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Brandon Hassid, MD</last_name>
    <phone>916-734-5292</phone>
    <email>bvhassid@ucdavis.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Dana Sheng, MD</last_name>
    <email>dana.sheng@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UC Davis Sports Medicine</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95816</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Brandon Hassid, MD</last_name>
      <phone>916-734-6805</phone>
      <email>bvhassid@ucdavis.edu</email>
    </contact>
    <investigator>
      <last_name>Kevin Mullins, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://studypages.com/s/using-kinect-motion-capture-to-measure-shoulder-motion-for-capsular-distension-in-adhesive-capsulitis-frozen-shoulder-654329/</url>
    <description>Learn more or sign up for the study here!</description>
  </link>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>August 15, 2022</last_update_submitted>
  <last_update_submitted_qc>August 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>adhesive capsulitis</keyword>
  <keyword>frozen shoulder</keyword>
  <keyword>shoulder pain</keyword>
  <keyword>range of motion</keyword>
  <keyword>capsular distention</keyword>
  <keyword>capsular distension</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Pain</mesh_term>
    <mesh_term>Bursitis</mesh_term>
    <mesh_term>Mobility Limitation</mesh_term>
    <mesh_term>Dilatation, Pathologic</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/NCT04413162
org study id: 1490166
nct id: NCT04413162
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study will compare shoulder range of motion assessment using the Kinect motion tracking
      system vs goniometer in patients with adhesive capsulitis (frozen shoulder) undergoing
      ultrasound-guided capsular distention procedures (standard of care).

      The investigators hypothesize that, for shoulder adhesive capsulitis, the Kinect Motion
      Analysis 2.0 system will provide reliable results in a shorter and more efficient amount of
      time in comparison to traditional goniometer methods.
The study will be a single-center, investigator-initiated protocol to assess the reliability
      of the Kinect Motion Analysis 2.0 Motion Tracking System for Range Of Motion (ROM) assessment
      in patients with Shoulder Adhesive Capsulitis undergoing ultrasound guided capsular
      distention procedures (standard of care for adhesive capsulitis). Secondarily, the study will
      describe the relationship between range of motion of the shoulder girdle in the four
      quadrants of normalized reachable workspace by the Kinect 2.0, PROMIS person-reported outcome
      scores for pain, pain interference and function (general mobility and upper extremity
      function), and VAS pain scores.

      Study participants are anticipated to remain in the study for 12 weeks: an initial visit
      followed by 6- and 12-week follow up visits. Given the nature of scheduling appointments in
      medical clinics, 12 weeks is an approximation; the actual duration may occasionally be 1-2
      weeks longer if needed to successfully complete the follow-up visit.

      The investigators hypothesize that, for shoulder adhesive capsulitis, the Kinect Motion
      Analysis 2.0 system will provide reliable results in a shorter and more efficient amount of
      time in comparison to traditional goniometer methods.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: change in shoulder range of motion
time frame: 12 weeks
description: measured in degrees (high number of degrees = better range of motion)
measure: PROMIS score - upper extremity
time frame: 12 weeks
description: Patient-Reported Outcomes Measurement Information System (PROMIS) is a validated, 46-item, self-reported system to assess physical function and symptoms in patients with disorders of the limb. Range of possible values: 46-230. (Higher score indicates higher function and outcomes)
measure: DASH score
time frame: 12 weeks
description: The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 38-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. Range of possible values: 38-150. (Lower score indicates better function / less disability)
measure: VAS score
time frame: 12 weeks
description: Visual analog scale is a validated, subjective measure for pain. Range of possible values: 0-10. (Higher score indicates more pain)
arm group label: measurement before and after capsular distention
arm group type: Other
intervention type: Other
intervention name: Kinect motion tracking system
description: Kinect motion tracking system is used to measure shoulder range of motion compared to goniometric measurement.
arm group label: measurement before and after capsular distention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kevin Mullins, MD
role: Principal Investigator
affiliation: UC Davis Health
last name: Brandon Hassid, MD
phone: 916-734-5292
email: bvhassid@ucdavis.edu
last name: Dana Sheng, MD
email: dana.sheng@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
url: https://studypages.com/s/using-kinect-motion-capture-to-measure-shoulder-motion-for-capsular-distension-in-adhesive-capsulitis-frozen-shoulder-654329/
description: Learn more or sign up for the study here!
responsible party type: Sponsor
mesh term: Shoulder Pain
mesh term: Bursitis
mesh term: Mobility Limitation
mesh term: Dilatation, Pathologic