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/NCT06006988</url>
    </required_header>
    <id_info>
      <org_study_id>DrHakanPolat</org_study_id>
      <nct_id>NCT06006988</nct_id>
    </id_info>
    <brief_title>Trunk Control and Viscoelastic Properties of Trunk Muscles in Acute Stroke Patients</brief_title>
    <official_title>Investigation of the Relationship Between Trunk Control and Viscoelastic Properties of Trunk Muscles in Acute Stroke Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sanko University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sanko 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>
        Stroke is a health problem that ranks second among the causes of death and third in the rate&#xD;
        of severe disability . One of the most commonly reported problems after stroke is the&#xD;
        structural and functional changes in the muscles . At the beginning of the structural changes&#xD;
        of the muscles is the effect of the viscoelastic properties of the muscles. Various studies&#xD;
        have reported an increase in skeletal muscle stiffness, which is dependent on elasticity as&#xD;
        well as muscle viscosity after stroke . The initial condition of the affected trunk on both&#xD;
        the ipsilateral and contralateral sides after stroke is defined as the earliest and most&#xD;
        important factor in predicting functional recovery. Functional recovery after stroke was&#xD;
        found to be associated with trunk control at a rate of 45-71% in general . We think that&#xD;
        viscoelastic properties will change in trunk muscles of individuals with acute stroke and&#xD;
        these changes may be related to trunk control disorder.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Trunk control is the ability to maintain an upright posture, adjust weight shift, and perform&#xD;
        selective movements in the trunk to keep the center of gravity within the base of support .&#xD;
        Stroke is one of the main causes of impaired trunk control, including center of gravity and&#xD;
        balance reaction . In stroke patients, trunk control ability is decreased in all planes,&#xD;
        especially in the frontal plane. Studies have reported that stroke patients have a decrease&#xD;
        in trunk muscle strength compared to healthy individuals , and when trunk proprioception is&#xD;
        measured in chronic stroke patients, it is affected more than healthy participants . In&#xD;
        addition, skeletal muscles undergo various changes after stroke. These changes that occur in&#xD;
        the musculoskeletal system are muscle weakness, fatigue, and abnormal muscle tone . Changes&#xD;
        at the muscle level include tissue elasticity and viscous properties. In patients with&#xD;
        stroke, trunk control should be at a sufficient level in order to ensure functionality in the&#xD;
        acute period. Muscle tone and viscoelasticity must be normal in order for trunk control to be&#xD;
        at an adequate level. For this reason, in our study, the ability to control the trunk of&#xD;
        patients with acute stroke will be associated with the viscoelastic properties of trunk&#xD;
        muscles. Gaining a better understanding of changes in tissue distribution by looking at the&#xD;
        viscoelasticity of trunk muscles and comparing them to the unaffected intact extremity will&#xD;
        lead to better and more targeted interventions for rehabilitation.&#xD;
  &#xD;
        The study will be carried out at Sanko University Sani Konukoğlu Practice and Research&#xD;
        Hospital. Acute stroke patients who will voluntarily participate in the study will be&#xD;
        included.&#xD;
  &#xD;
        Inclusion criteria;&#xD;
  &#xD;
          -  Patients with ischemic cerebro-vascular disease within the first 72 hours,&#xD;
  &#xD;
          -  Patients with a National Institute of Health (NIH) score below 15&#xD;
  &#xD;
          -  No additional neurological and orthopedic problems&#xD;
  &#xD;
          -  Patients who do not have any inconvenience in sitting hemodynamically&#xD;
  &#xD;
          -  agree to participate in the study voluntarily Exclusion criteria;&#xD;
  &#xD;
          -  Patients who come to the service outside the first 72 hours&#xD;
  &#xD;
          -  Uncooperative patients&#xD;
  &#xD;
          -  patients who have had two or more strokes&#xD;
  &#xD;
          -  Those who have had a Trans Ischemic Attack (TIA)&#xD;
  &#xD;
          -  Refused to participate in the study Patients who are hospitalized from SANKO University&#xD;
             Hospital Neurology Service will be included in the study. Socio-demographic information&#xD;
             of the included patients will be obtained. Then, trunk impairment scale, which is a&#xD;
             17-item scale developed to evaluate trunk performance in stroke patients, will be used&#xD;
             for trunk control . MyotonPro device will be used to measure the elasticity of Thoracis&#xD;
             Longissimus, Lumbar Multifidus, Trapeze and Rectus Femoris muscles.&#xD;
  &#xD;
        Demographic information form: this form is a form that evaluates the demographic information,&#xD;
        contact information and general information of individuals.&#xD;
  &#xD;
        Trunk impairment scale: It is a 17-parameter scale developed to evaluate trunk control in&#xD;
        patients with neurological deficits . Existing sections in the scale; static sitting balance&#xD;
        (GBÖ Static), dynamic sitting balance (GBÖ Dynamic) and coordination (GBÖ Coordination). The&#xD;
        total score is a minimum of 0 and a maximum of 23 points and it is accepted that the higher&#xD;
        score shows better performance. For the initial position in all items, the patients are asked&#xD;
        to sit with the thighs parallel to the floor, feet in full contact with the ground, knees&#xD;
        flexed to 90º, without back support, with the hands and forearms supported on the thighs. All&#xD;
        items are repeated 3 times and the best performance of the patient is recorded. In between&#xD;
        tests, the patient is given stimuli and verbal or visual feedback by the observer. A total&#xD;
        score of 0 is given to individuals who cannot maintain the starting position for 10 seconds.&#xD;
        A Turkish validity and reliability study of the GBS in stroke patients was performed .&#xD;
  &#xD;
        MyotonPRO is a mobile, removable handheld myotonometer. This tool is noninvasive and provides&#xD;
        a quantitative assessment of a muscle's viscoelastic properties. These properties are&#xD;
        characterized by various parameters such as hardness, tone and elasticity. The probe of&#xD;
        MyotonPRO delivers a short (15 ms), low intensity (0.58 N) mechanical impact/impact on the&#xD;
        skin on the muscle. The response of the touch then generates a recorded signal and an&#xD;
        internal software program generates an acceleration graph. Measurements of various&#xD;
        viscoelastic muscle properties such as stiffness, tone, and elasticity are then extracted&#xD;
        from this graph . Measurements of Thoracis Longissimus, Lumbar Multifidus, Trapeze and Rectus&#xD;
        Femoris muscles will be recorded bilaterally, in 3-repetition measurements.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 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>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>trunk disorder scale</measure>
      <time_frame>1 weeks</time_frame>
      <description>It is a scale consisting of 17 parameters developed for the evaluation of trunk control in patients with neurological deficits (EK8). Existing sections in the scale; static sitting balance (GBÖ Static), dynamic sitting balance (GBÖ Dynamic) and coordination (GBÖ Coordination). The total score is a minimum of 0 and a maximum of 23 points and it is accepted that the higher score shows better performance. For the initial position in all items, the patients are asked to sit with the thighs parallel to the floor, feet in full contact with the ground, knees flexed to 90º, without back support, with the hands and forearms supported on the thighs. All items are repeated 3 times and the best performance of the patient is recorded. In between tests, the patient is given stimuli and verbal or visual feedback by the observer.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>viscoelastic properties of muscle</measure>
      <time_frame>1 weeks</time_frame>
      <description>MyotonPRO is a mobile, removable handheld myotonometer. This tool is noninvasive and provides a quantitative assessment of a muscle's viscoelastic properties. These properties are characterized by various parameters such as hardness, tone and elasticity. The probe of MyotonPRO delivers a short (15 ms), low intensity (0.58 N) mechanical impact/impact on the skin on the muscle. The response of the touch then generates a recorded signal and an internal software program generates an acceleration graph. Measurements of various viscoelastic muscle properties such as stiffness, tone and elasticity are then extracted from this graph. Measurements of Thoracis Longissimus, Lumbar Multifidus, Trapeze and Rectus Femoris muscles will be recorded bilaterally, in 3-repetition measurements.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Stroke</condition>
    <arm_group>
      <arm_group_label>trunk disorder scale</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>It is a 17-parameter scale developed for the evaluation of trunk control. Existing sections in the scale; static sitting balance (GBÖ Static), dynamic sitting balance (GBÖ Dynamic) and coordination (GBÖ Coordination). The total score is a minimum of 0 and a maximum of 23 points and it is accepted that the higher score shows better performance.</description>
    </arm_group>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>myoton pro</intervention_name>
      <description>MyotonPRO is a mobile, removable handheld myotonometer. This tool is noninvasive and provides a quantitative assessment of a muscle's viscoelastic properties. These properties are characterized by various parameters such as hardness, tone and elasticity. The probe of MyotonPRO delivers a short (15 ms), low intensity (0.58 N) mechanical impact/impact on the skin on the muscle. The response of the touch then generates a recorded signal and an internal software program generates an acceleration graph. Measurements of various viscoelastic muscle properties such as stiffness, tone and elasticity are then extracted from this graph.</description>
      <arm_group_label>trunk disorder scale</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with ischemic cerebro-vascular disease within the first 72 hours,&#xD;
  &#xD;
                 -  Patients with a National Institute of Health (NIH) score below 15&#xD;
  &#xD;
                 -  No additional neurological and orthopedic problems&#xD;
  &#xD;
                 -  Patients who do not have any inconvenience in sitting hemodynamically&#xD;
  &#xD;
                 -  agree to participate in the study voluntarily&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who come to the service outside the first 72 hours&#xD;
  &#xD;
            -  Uncooperative patients&#xD;
  &#xD;
            -  patients who have had two or more strokes&#xD;
  &#xD;
            -  Those who have had a Trans Ischemic Attack (TIA)&#xD;
  &#xD;
            -  Refused to participate in the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Hakan Polat</last_name>
      <phone>05386487265</phone>
      <email>hakan.polat@sanko.edu.tr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Sanko University</name>
        <address>
          <city>Gaziantep</city>
          <zip>27500</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>hakan polat, Dr.</last_name>
        <phone>05386487265</phone>
        <email>hakan.polat@sanko.edu.tr</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sanko University</investigator_affiliation>
      <investigator_full_name>Hakan Polat</investigator_full_name>
      <investigator_title>Director</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stroke</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/NCT06006988
  org study id: DrHakanPolat
  nct id: NCT06006988
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Stroke is a health problem that ranks second among the causes of death and third in the rate
        of severe disability . One of the most commonly reported problems after stroke is the
        structural and functional changes in the muscles . At the beginning of the structural changes
        of the muscles is the effect of the viscoelastic properties of the muscles. Various studies
        have reported an increase in skeletal muscle stiffness, which is dependent on elasticity as
        well as muscle viscosity after stroke . The initial condition of the affected trunk on both
        the ipsilateral and contralateral sides after stroke is defined as the earliest and most
        important factor in predicting functional recovery. Functional recovery after stroke was
        found to be associated with trunk control at a rate of 45-71% in general . We think that
        viscoelastic properties will change in trunk muscles of individuals with acute stroke and
        these changes may be related to trunk control disorder.
  Trunk control is the ability to maintain an upright posture, adjust weight shift, and perform
        selective movements in the trunk to keep the center of gravity within the base of support .
        Stroke is one of the main causes of impaired trunk control, including center of gravity and
        balance reaction . In stroke patients, trunk control ability is decreased in all planes,
        especially in the frontal plane. Studies have reported that stroke patients have a decrease
        in trunk muscle strength compared to healthy individuals , and when trunk proprioception is
        measured in chronic stroke patients, it is affected more than healthy participants . In
        addition, skeletal muscles undergo various changes after stroke. These changes that occur in
        the musculoskeletal system are muscle weakness, fatigue, and abnormal muscle tone . Changes
        at the muscle level include tissue elasticity and viscous properties. In patients with
        stroke, trunk control should be at a sufficient level in order to ensure functionality in the
        acute period. Muscle tone and viscoelasticity must be normal in order for trunk control to be
        at an adequate level. For this reason, in our study, the ability to control the trunk of
        patients with acute stroke will be associated with the viscoelastic properties of trunk
        muscles. Gaining a better understanding of changes in tissue distribution by looking at the
        viscoelasticity of trunk muscles and comparing them to the unaffected intact extremity will
        lead to better and more targeted interventions for rehabilitation.
  
        The study will be carried out at Sanko University Sani Konukoğlu Practice and Research
        Hospital. Acute stroke patients who will voluntarily participate in the study will be
        included.
  
        Inclusion criteria;
  
          -  Patients with ischemic cerebro-vascular disease within the first 72 hours,
  
          -  Patients with a National Institute of Health (NIH) score below 15
  
          -  No additional neurological and orthopedic problems
  
          -  Patients who do not have any inconvenience in sitting hemodynamically
  
          -  agree to participate in the study voluntarily Exclusion criteria;
  
          -  Patients who come to the service outside the first 72 hours
  
          -  Uncooperative patients
  
          -  patients who have had two or more strokes
  
          -  Those who have had a Trans Ischemic Attack (TIA)
  
          -  Refused to participate in the study Patients who are hospitalized from SANKO University
             Hospital Neurology Service will be included in the study. Socio-demographic information
             of the included patients will be obtained. Then, trunk impairment scale, which is a
             17-item scale developed to evaluate trunk performance in stroke patients, will be used
             for trunk control . MyotonPro device will be used to measure the elasticity of Thoracis
             Longissimus, Lumbar Multifidus, Trapeze and Rectus Femoris muscles.
  
        Demographic information form: this form is a form that evaluates the demographic information,
        contact information and general information of individuals.
  
        Trunk impairment scale: It is a 17-parameter scale developed to evaluate trunk control in
        patients with neurological deficits . Existing sections in the scale; static sitting balance
        (GBÖ Static), dynamic sitting balance (GBÖ Dynamic) and coordination (GBÖ Coordination). The
        total score is a minimum of 0 and a maximum of 23 points and it is accepted that the higher
        score shows better performance. For the initial position in all items, the patients are asked
        to sit with the thighs parallel to the floor, feet in full contact with the ground, knees
        flexed to 90º, without back support, with the hands and forearms supported on the thighs. All
        items are repeated 3 times and the best performance of the patient is recorded. In between
        tests, the patient is given stimuli and verbal or visual feedback by the observer. A total
        score of 0 is given to individuals who cannot maintain the starting position for 10 seconds.
        A Turkish validity and reliability study of the GBS in stroke patients was performed .
  
        MyotonPRO is a mobile, removable handheld myotonometer. This tool is noninvasive and provides
        a quantitative assessment of a muscle's viscoelastic properties. These properties are
        characterized by various parameters such as hardness, tone and elasticity. The probe of
        MyotonPRO delivers a short (15 ms), low intensity (0.58 N) mechanical impact/impact on the
        skin on the muscle. The response of the touch then generates a recorded signal and an
        internal software program generates an acceleration graph. Measurements of various
        viscoelastic muscle properties such as stiffness, tone, and elasticity are then extracted
        from this graph . Measurements of Thoracis Longissimus, Lumbar Multifidus, Trapeze and Rectus
        Femoris muscles will be recorded bilaterally, in 3-repetition measurements.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: trunk disorder scale
  time frame: 1 weeks
  description: It is a scale consisting of 17 parameters developed for the evaluation of trunk control in patients with neurological deficits (EK8). Existing sections in the scale; static sitting balance (GBÖ Static), dynamic sitting balance (GBÖ Dynamic) and coordination (GBÖ Coordination). The total score is a minimum of 0 and a maximum of 23 points and it is accepted that the higher score shows better performance. For the initial position in all items, the patients are asked to sit with the thighs parallel to the floor, feet in full contact with the ground, knees flexed to 90º, without back support, with the hands and forearms supported on the thighs. All items are repeated 3 times and the best performance of the patient is recorded. In between tests, the patient is given stimuli and verbal or visual feedback by the observer.
  measure: viscoelastic properties of muscle
  time frame: 1 weeks
  description: MyotonPRO is a mobile, removable handheld myotonometer. This tool is noninvasive and provides a quantitative assessment of a muscle's viscoelastic properties. These properties are characterized by various parameters such as hardness, tone and elasticity. The probe of MyotonPRO delivers a short (15 ms), low intensity (0.58 N) mechanical impact/impact on the skin on the muscle. The response of the touch then generates a recorded signal and an internal software program generates an acceleration graph. Measurements of various viscoelastic muscle properties such as stiffness, tone and elasticity are then extracted from this graph. Measurements of Thoracis Longissimus, Lumbar Multifidus, Trapeze and Rectus Femoris muscles will be recorded bilaterally, in 3-repetition measurements.
  arm group label: trunk disorder scale
  arm group type: Experimental
  description: It is a 17-parameter scale developed for the evaluation of trunk control. Existing sections in the scale; static sitting balance (GBÖ Static), dynamic sitting balance (GBÖ Dynamic) and coordination (GBÖ Coordination). The total score is a minimum of 0 and a maximum of 23 points and it is accepted that the higher score shows better performance.
  intervention type: Combination Product
  intervention name: myoton pro
  description: MyotonPRO is a mobile, removable handheld myotonometer. This tool is noninvasive and provides a quantitative assessment of a muscle's viscoelastic properties. These properties are characterized by various parameters such as hardness, tone and elasticity. The probe of MyotonPRO delivers a short (15 ms), low intensity (0.58 N) mechanical impact/impact on the skin on the muscle. The response of the touch then generates a recorded signal and an internal software program generates an acceleration graph. Measurements of various viscoelastic muscle properties such as stiffness, tone and elasticity are then extracted from this graph.
  arm group label: trunk disorder scale
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Hakan Polat
  phone: 05386487265
  email: hakan.polat@sanko.edu.tr
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Sanko University
  investigator full name: Hakan Polat
  investigator title: Director
  mesh term: Stroke
  sharing ipd: No