xml: <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/NCT06041542</url>
    </required_header>
    <id_info>
      <org_study_id>GDREC2020291H</org_study_id>
      <nct_id>NCT06041542</nct_id>
    </id_info>
    <brief_title>Evaluation of the Screening Effect of Artificial Intelligence Hand Activity Evaluation System for Cervical Spondylosis</brief_title>
    <official_title>Evaluation of the Screening Effect of Artificial Intelligence Hand Activity Evaluation System for Cervical Spondylosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Guangdong Provincial People's Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Guangdong Provincial People's Hospital</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>
        The purpose of this study:&#xD;
  &#xD;
          1. Build an artificial intelligence screening tool for cervical spondylosis based on hand&#xD;
             function analysis;&#xD;
  &#xD;
          2. Verify the accuracy of cervical spondylosis screening tools.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Cervical spondylotic myelopathy (CSM) has a high incidence in the middle-aged and elderly&#xD;
        people. According to clinical research, the surgeon can makes a preliminary assessment of the&#xD;
        severity of CSM based on a 10-second grip and release (G&amp;R) test. The statistics of G&amp;R test&#xD;
        mainly rely on the surgeon's manual counting. When a patient's hand motion speed is too fast,&#xD;
        the surgeon's manual counting is prone to error, leading to potential misdiagnosis. We&#xD;
        construct and verify the intelligent video analysis system for Grip-&amp;-release. The system has&#xD;
        a high accuracy and inference speed that ensure the proposed model can be used as a screening&#xD;
        examination tool for CSM and a medical assistance tool to help decision making during CSM&#xD;
        treatment planning.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 1, 2020</start_date>
    <completion_date type="Actual">December 30, 2022</completion_date>
    <primary_completion_date type="Actual">May 31, 2022</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>mJOA score</measure>
      <time_frame>2022-10-01-2022-12-30</time_frame>
      <description>Correlate 10-second hand grip and release test with mJOA score</description>
    </primary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Actual">1380</enrollment>
    <condition>10-second G&amp;R Test</condition>
    <arm_group>
      <arm_group_label>Case group</arm_group_label>
      <description>Collect video of hand grasping from patients with cervical spondylotic myelopathy through intelligent video analysis system.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <description>Collect video of hand grasping from normal people through intelligent video analysis system.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Differentiate group</arm_group_label>
      <description>Collect video of hand grasping from Stroke and Parkinson's disease through intelligent video analysis system.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>10-second hand grip and release test</intervention_name>
      <description>To grip and release hand in ten seconds</description>
      <arm_group_label>Case group</arm_group_label>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_label>Differentiate group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          1000 asymptomatic population in community; 200 cases of cervical spondylosis; Arthritis,&#xD;
          Parkinson's disease, cerebral apoplexy 60 patients each.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age between 18-80 years old;&#xD;
  &#xD;
            2. Patients who have received cervical CT or MR examination within the last month and&#xD;
               have been clearly diagnosed or excluded from cervical spondylosis (i.e., those who&#xD;
               have been clearly diagnosed before participating in the study);&#xD;
  &#xD;
            3. People who are willing to participate in the study with CT/MR examination (i.e., those&#xD;
               who have not been diagnosed before joining the study).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Subjects with cervical spondylosis who have been examined but still cannot be&#xD;
               definitively diagnosed or ruled out;&#xD;
  &#xD;
            2. Subjects with definite presence of hand trauma;&#xD;
  &#xD;
            3. People who do not have access to CT or MR;&#xD;
  &#xD;
            4. Subjects who did not comply with the examination, were unable to perform neurological&#xD;
               assessment, or were unable to fill out questionnaires.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yunbing Chang, M.D.</last_name>
      <role>Study Chair</role>
      <affiliation>Guangdong Provincial People's Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Guangdong Provincial People's Hospital</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510080</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 3, 2022</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Guangdong Provincial People's Hospital</investigator_affiliation>
      <investigator_full_name>YunBing Chang</investigator_full_name>
      <investigator_title>Head of spine Department</investigator_title>
    </responsible_party>
    <keyword>10-second G&amp;R test</keyword>
    <keyword>cervical spondylotic myelopathy</keyword>
    <keyword>hand motion analysis</keyword>
    <keyword>video analysis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Spondylosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06041542
  org study id: GDREC2020291H
  nct id: NCT06041542
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study:
  
          1. Build an artificial intelligence screening tool for cervical spondylosis based on hand
             function analysis;
  
          2. Verify the accuracy of cervical spondylosis screening tools.
  Cervical spondylotic myelopathy (CSM) has a high incidence in the middle-aged and elderly
        people. According to clinical research, the surgeon can makes a preliminary assessment of the
        severity of CSM based on a 10-second grip and release (G&R) test. The statistics of G&R test
        mainly rely on the surgeon's manual counting. When a patient's hand motion speed is too fast,
        the surgeon's manual counting is prone to error, leading to potential misdiagnosis. We
        construct and verify the intelligent video analysis system for Grip-&-release. The system has
        a high accuracy and inference speed that ensure the proposed model can be used as a screening
        examination tool for CSM and a medical assistance tool to help decision making during CSM
        treatment planning.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: mJOA score
  time frame: 2022-10-01-2022-12-30
  description: Correlate 10-second hand grip and release test with mJOA score
  arm group label: Case group
  description: Collect video of hand grasping from patients with cervical spondylotic myelopathy through intelligent video analysis system.
  arm group label: Control group
  description: Collect video of hand grasping from normal people through intelligent video analysis system.
  arm group label: Differentiate group
  description: Collect video of hand grasping from Stroke and Parkinson's disease through intelligent video analysis system.
  intervention type: Diagnostic Test
  intervention name: 10-second hand grip and release test
  description: To grip and release hand in ten seconds
  arm group label: Case group
  arm group label: Control group
  arm group label: Differentiate group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 80 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Yunbing Chang, M.D.
  role: Study Chair
  affiliation: Guangdong Provincial People's Hospital
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Guangdong Provincial People's Hospital
  investigator full name: YunBing Chang
  investigator title: Head of spine Department
  mesh term: Spondylosis
  sharing ipd: Undecided