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/NCT05965791</url>
    </required_header>
    <id_info>
      <org_study_id>OT-PT-001</org_study_id>
      <nct_id>NCT05965791</nct_id>
    </id_info>
    <brief_title>Median Nerve Function During Phalen's Test</brief_title>
    <official_title>Electrophysiological Assessment of the Median Nerve During the Phalen's Test for Carpal Tunnel Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ahram Canadian University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ahram Canadian University</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 use electromyography and nerve conduction studies to evaluate median nerve&#xD;
        function during the Phalen's wrist flexion test in different wrist positions.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The Phalen's test is commonly used to assess carpal tunnel syndrome. However, it is unclear&#xD;
        which wrist position during this test best isolates median nerve function. This study will&#xD;
        measure thenar muscle activation and median nerve conduction in 30 healthy participants&#xD;
        performing the Phalen's test. Different wrist flexion angles will be evaluated to determine&#xD;
        which position optimally targets the median nerve. Results may enhance utilization of the&#xD;
        Phalen's test in clinical practice and research.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">July 25, 2023</start_date>
    <completion_date type="Anticipated">December 15, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 25, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Thenar Muscle Activation</measure>
      <time_frame>Baseline</time_frame>
      <description>Mean EMG activity of the thenar muscles during the Phalen's test at different wrist angles. Measured in microvolts (μV).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Median Nerve Conduction Velocity during Phalen's Test</measure>
      <time_frame>Baseline</time_frame>
      <description>Median nerve conduction velocity (measured in meters per second, m/s) assessed using surface electrodes at the wrist and elbow during the Phalen's test wrist flexion maneuver. Measured bilaterally at each wrist flexion angle during a single study visit.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Median Nerve Distal Latency during Phalen's Test</measure>
      <time_frame>Baseline</time_frame>
      <description>Median nerve distal latency (measured in milliseconds, ms) assessed using surface electrodes over the abductor pollicis brevis and stimulating the median nerve at the wrist during the Phalen's test. Measured bilaterally at each wrist flexion angle during a single study visit.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Carpal Tunnel Syndrome</condition>
    <arm_group>
      <arm_group_label>Healthy Adults</arm_group_label>
      <description>30 healthy adult participants aged 18-45 years performing the Phalen's wrist flexion test</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Phalen's wrist flexion test</intervention_name>
      <description>The Phalen's test will be performed at different wrist flexion angles from 0 to 90 degrees.</description>
      <arm_group_label>Healthy Adults</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Healthy men and women aged 18-45 recruited from the local community.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Healthy adults aged 18-45 years&#xD;
  &#xD;
            -  No history of hand/wrist disorders&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Contraindications to EMG or NCV&#xD;
  &#xD;
            -  Neurological or muscular disorders&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Amal Fawzy, Ph.d</last_name>
      <role>Study Chair</role>
      <affiliation>Faculty of Physical Therapy, Ahram Canadian University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mohamed M ElMeligie, Ph.d</last_name>
      <phone>+201064442032</phone>
      <email>mohamed.elmeligie@acu.edu.eg</email>
    </overall_contact>
    <location>
      <facility>
        <name>Outpatient clinic of faculty of physical therapy, Ahram Canadian University</name>
        <address>
          <city>Al Ḩayy Ath Thāmin</city>
          <state>Giza</state>
          <zip>3221405</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mohamed M ElMeligie, Ph.d</last_name>
        <phone>01064442032</phone>
        <email>mohamed.elmeligie@acu.edu.eg</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ahram Canadian University</investigator_affiliation>
      <investigator_full_name>Mohamed Magdy ElMeligie</investigator_full_name>
      <investigator_title>Lecturer of Physical Therapy and Director of Electromyography Lab</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carpal Tunnel Syndrome</mesh_term>
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT05965791
  org study id: OT-PT-001
  nct id: NCT05965791
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study will use electromyography and nerve conduction studies to evaluate median nerve
        function during the Phalen's wrist flexion test in different wrist positions.
  The Phalen's test is commonly used to assess carpal tunnel syndrome. However, it is unclear
        which wrist position during this test best isolates median nerve function. This study will
        measure thenar muscle activation and median nerve conduction in 30 healthy participants
        performing the Phalen's test. Different wrist flexion angles will be evaluated to determine
        which position optimally targets the median nerve. Results may enhance utilization of the
        Phalen's test in clinical practice and research.
  observational model: Other
  time perspective: Cross-Sectional
  measure: Thenar Muscle Activation
  time frame: Baseline
  description: Mean EMG activity of the thenar muscles during the Phalen's test at different wrist angles. Measured in microvolts (μV).
  measure: Median Nerve Conduction Velocity during Phalen's Test
  time frame: Baseline
  description: Median nerve conduction velocity (measured in meters per second, m/s) assessed using surface electrodes at the wrist and elbow during the Phalen's test wrist flexion maneuver. Measured bilaterally at each wrist flexion angle during a single study visit.
  measure: Median Nerve Distal Latency during Phalen's Test
  time frame: Baseline
  description: Median nerve distal latency (measured in milliseconds, ms) assessed using surface electrodes over the abductor pollicis brevis and stimulating the median nerve at the wrist during the Phalen's test. Measured bilaterally at each wrist flexion angle during a single study visit.
  arm group label: Healthy Adults
  description: 30 healthy adult participants aged 18-45 years performing the Phalen's wrist flexion test
  intervention type: Diagnostic Test
  intervention name: Phalen's wrist flexion test
  description: The Phalen's test will be performed at different wrist flexion angles from 0 to 90 degrees.
  arm group label: Healthy Adults
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Amal Fawzy, Ph.d
  role: Study Chair
  affiliation: Faculty of Physical Therapy, Ahram Canadian University
  last name: Mohamed M ElMeligie, Ph.d
  phone: +201064442032
  email: mohamed.elmeligie@acu.edu.eg
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Ahram Canadian University
  investigator full name: Mohamed Magdy ElMeligie
  investigator title: Lecturer of Physical Therapy and Director of Electromyography Lab
  mesh term: Carpal Tunnel Syndrome
  mesh term: Syndrome
  sharing ipd: No