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/NCT06004635</url>
    </required_header>
    <id_info>
      <org_study_id>BEU-KTS-02</org_study_id>
      <nct_id>NCT06004635</nct_id>
    </id_info>
    <brief_title>Reliability of Myotonometry in the Assessment of Mechanical Properties of Thenar Muscles</brief_title>
    <official_title>Reliability of Myotonometry in the Assessment of Mechanical Properties of Thenar Muscles: Relationship With Handgrip Strength, Reaction Time and Left/Right Discrimination</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ilke KARA</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Dokuz Eylul University</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>
        This study aims: (i) to determine the intra- and inter-observer reliability of myotonometry&#xD;
        in assessing the mechanical properties of the thenar muscles [abductor pollicis brevis (APB)&#xD;
        and flexor pollicis brevis (FPB)] in healthy subjects; (ii) to investigate the relationship&#xD;
        between reaction time, left/right discrimination, grip strength and these mechanical&#xD;
        properties.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Investigating the mechanical properties of hand muscles using simple applicable methods such&#xD;
        as myotonometry can help to evaluate the effectiveness of programs used in hand&#xD;
        rehabilitation, optimize the skills of performance-oriented individuals such as athletes and&#xD;
        musicians, and create individualized treatment and training programs. In&#xD;
        musculoskeletal-related pathologies such as carpal tunnel syndrome, studying the mechanical&#xD;
        properties of the thenar muscles may be important to better understand hand grip strength,&#xD;
        hand function and mobility. However, the use of myotonometer in the evaluation of the&#xD;
        mechanical properties of the thenar muscles requires a reliability study. Accordingly, the&#xD;
        aims of our study are: (i) to determine the intra- and inter-observer reliability of&#xD;
        myotonometry in assessing the mechanical properties of the thenar muscles [abductor pollicis&#xD;
        brevis (APB) and flexor pollicis brevis (FPB)] in healthy subjects; (ii) to investigate the&#xD;
        relationship between reaction time, left/right discrimination, grip strength and these&#xD;
        mechanical properties.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">November 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2024</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>Muscle tone (Hz)</measure>
      <time_frame>Day 1</time_frame>
      <description>The muscle tone which is a biomechanical property of the forearm muscles will be evaluated with a portable hand-held myotonometer. This myotonometer (MyotonPRO - Tallinn, Estonia) is non-invasive and provides a quantitative assessment of a muscle's biomechanical properties. The MyotonPRO applies a short-intensity mechanical impulse on the skin overlying the muscle or facia. The tissue's response then generates a signal that is recorded, and an internal software program produces an acceleration graph. To determine the feasibility of the MyotonPRO for assessing the muscle tone of forearm muscles measurements will be performed and recorded.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Stiffness (N/m)</measure>
      <time_frame>Day 1</time_frame>
      <description>The stiffness which is a biomechanical property of the forearm muscles will be evaluated with a portable hand-held myotonometer. This myotonometer (MyotonPRO - Tallinn, Estonia) is non-invasive and provides a quantitative assessment of a muscle's biomechanical properties. The MyotonPRO applies a short-intensity mechanical impulse on the skin overlying the muscle or facia. The tissue's response then generates a signal that is recorded, and an internal software program produces an acceleration graph. To determine the feasibility of the MyotonPRO for assessing the stiffness of forearm muscles measurements will be performed and recorded.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Elasticity (Logarithmic decrement)</measure>
      <time_frame>Day 1</time_frame>
      <description>The elasticity which is a viscoelastic property of the forearm muscles will be evaluated with a portable hand-held myotonometer. This myotonometer (MyotonPRO - Tallinn, Estonia) is non-invasive and provides a quantitative assessment of a muscle's viscoelastic properties. The MyotonPRO applies a short-intensity mechanical impulse on the skin overlying the muscle or facia. The tissue's response then generates a signal that is recorded, and an internal software program produces an acceleration graph. To determine the feasibility of the MyotonPRO for assessing the stiffness of forearm muscles measurements will be performed and recorded.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Grip and pinch strength</measure>
      <time_frame>Day 1</time_frame>
      <description>Hand grip strength will be measured using a hydraulic hand dynamometer (Baseline). Pinch grip strength will be assessed using a hydraulic pinchmeter (Baseline). Standard procedures recommended by ASHT will be followed. Hand grip strength and pinch strength tests will be assessed with the elbow flexed 90 degrees as recommended by the American Society of Hand Therapists (ASHT).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Reaction time</measure>
      <time_frame>Day 1</time_frame>
      <description>BlazePod, a new technology for measuring individual reaction time (ms), will be used in the study. Participants will be asked to sit in a height-adjustable chair and position their dominant hand on the assessment table in as comfortable a position as possible. Once the participant's dominant hand is placed on the table, each pod will be placed 25 cm from the center of the hand to form a square pattern. Before starting the test, the participants will perform two practice trials in the same test setup as the real test in order to adapt to the test. Prior to the test, the mobile app will give the participant a three-second audible countdown warning and a start command. Participants will be instructed to touch the pods with the hand being tested to turn off the lights as quickly as possible and to maintain this throughout the test.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Left/Right Judgment Task</measure>
      <time_frame>Day 1</time_frame>
      <description>The Left/Right Discrimination Ability (LRJT) Task test will be performed using the Recognize® tablet application (RecogniseTM application, NOI, Neuro-orthopedic Institute). The Recognize hand assessment kit tablet version iPad (9.7 inch, iPad, Apple Computers) will be downloaded and used.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Muscular Tone</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Healthy adults between 18-35 years old&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
            -  being between 18 and 35 years of age&#xD;
  &#xD;
            -  having normal upper extremity function&#xD;
  &#xD;
            -  having a Montreal Cognitive Assessment Test (MoCA) score &gt; 26 points&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            -  any neuromuscular or musculoskeletal disease&#xD;
  &#xD;
            -  history of upper limb injury&#xD;
  &#xD;
            -  upper limb surgery within the last 6 months&#xD;
  &#xD;
            -  body mass index (BMI) &gt; 30 kg/m2.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>35 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Tülay Çevik Saldıran, PhD</last_name>
      <phone>+90 (434) 222 83 03</phone>
      <email>tcsaldiran@beu.edu.tr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Bitlis Eren University</name>
        <address>
          <city>Bitlis</city>
          <zip>13000</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Dokuz Eylul University</investigator_affiliation>
      <investigator_full_name>Ilke KARA</investigator_full_name>
      <investigator_title>Co-Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>elasticity</keyword>
    <keyword>hardness</keyword>
    <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/NCT06004635
  org study id: BEU-KTS-02
  nct id: NCT06004635
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aims: (i) to determine the intra- and inter-observer reliability of myotonometry
        in assessing the mechanical properties of the thenar muscles [abductor pollicis brevis (APB)
        and flexor pollicis brevis (FPB)] in healthy subjects; (ii) to investigate the relationship
        between reaction time, left/right discrimination, grip strength and these mechanical
        properties.
  Investigating the mechanical properties of hand muscles using simple applicable methods such
        as myotonometry can help to evaluate the effectiveness of programs used in hand
        rehabilitation, optimize the skills of performance-oriented individuals such as athletes and
        musicians, and create individualized treatment and training programs. In
        musculoskeletal-related pathologies such as carpal tunnel syndrome, studying the mechanical
        properties of the thenar muscles may be important to better understand hand grip strength,
        hand function and mobility. However, the use of myotonometer in the evaluation of the
        mechanical properties of the thenar muscles requires a reliability study. Accordingly, the
        aims of our study are: (i) to determine the intra- and inter-observer reliability of
        myotonometry in assessing the mechanical properties of the thenar muscles [abductor pollicis
        brevis (APB) and flexor pollicis brevis (FPB)] in healthy subjects; (ii) to investigate the
        relationship between reaction time, left/right discrimination, grip strength and these
        mechanical properties.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: Muscle tone (Hz)
  time frame: Day 1
  description: The muscle tone which is a biomechanical property of the forearm muscles will be evaluated with a portable hand-held myotonometer. This myotonometer (MyotonPRO - Tallinn, Estonia) is non-invasive and provides a quantitative assessment of a muscle's biomechanical properties. The MyotonPRO applies a short-intensity mechanical impulse on the skin overlying the muscle or facia. The tissue's response then generates a signal that is recorded, and an internal software program produces an acceleration graph. To determine the feasibility of the MyotonPRO for assessing the muscle tone of forearm muscles measurements will be performed and recorded.
  measure: Stiffness (N/m)
  time frame: Day 1
  description: The stiffness which is a biomechanical property of the forearm muscles will be evaluated with a portable hand-held myotonometer. This myotonometer (MyotonPRO - Tallinn, Estonia) is non-invasive and provides a quantitative assessment of a muscle's biomechanical properties. The MyotonPRO applies a short-intensity mechanical impulse on the skin overlying the muscle or facia. The tissue's response then generates a signal that is recorded, and an internal software program produces an acceleration graph. To determine the feasibility of the MyotonPRO for assessing the stiffness of forearm muscles measurements will be performed and recorded.
  measure: Elasticity (Logarithmic decrement)
  time frame: Day 1
  description: The elasticity which is a viscoelastic property of the forearm muscles will be evaluated with a portable hand-held myotonometer. This myotonometer (MyotonPRO - Tallinn, Estonia) is non-invasive and provides a quantitative assessment of a muscle's viscoelastic properties. The MyotonPRO applies a short-intensity mechanical impulse on the skin overlying the muscle or facia. The tissue's response then generates a signal that is recorded, and an internal software program produces an acceleration graph. To determine the feasibility of the MyotonPRO for assessing the stiffness of forearm muscles measurements will be performed and recorded.
  measure: Grip and pinch strength
  time frame: Day 1
  description: Hand grip strength will be measured using a hydraulic hand dynamometer (Baseline). Pinch grip strength will be assessed using a hydraulic pinchmeter (Baseline). Standard procedures recommended by ASHT will be followed. Hand grip strength and pinch strength tests will be assessed with the elbow flexed 90 degrees as recommended by the American Society of Hand Therapists (ASHT).
  measure: Reaction time
  time frame: Day 1
  description: BlazePod, a new technology for measuring individual reaction time (ms), will be used in the study. Participants will be asked to sit in a height-adjustable chair and position their dominant hand on the assessment table in as comfortable a position as possible. Once the participant's dominant hand is placed on the table, each pod will be placed 25 cm from the center of the hand to form a square pattern. Before starting the test, the participants will perform two practice trials in the same test setup as the real test in order to adapt to the test. Prior to the test, the mobile app will give the participant a three-second audible countdown warning and a start command. Participants will be instructed to touch the pods with the hand being tested to turn off the lights as quickly as possible and to maintain this throughout the test.
  measure: Left/Right Judgment Task
  time frame: Day 1
  description: The Left/Right Discrimination Ability (LRJT) Task test will be performed using the Recognize® tablet application (RecogniseTM application, NOI, Neuro-orthopedic Institute). The Recognize hand assessment kit tablet version iPad (9.7 inch, iPad, Apple Computers) will be downloaded and used.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 35 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Tülay Çevik Saldıran, PhD
  phone: +90 (434) 222 83 03
  email: tcsaldiran@beu.edu.tr
  facility: 
  country: Turkey
  responsible party type: Sponsor-Investigator
  investigator affiliation: Dokuz Eylul University
  investigator full name: Ilke KARA
  investigator title: Co-Principal Investigator
  sharing ipd: No