<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/NCT03814460</url>
  </required_header>
  <id_info>
    <org_study_id>Myoton18</org_study_id>
    <nct_id>NCT03814460</nct_id>
  </id_info>
  <brief_title>Stroke and Assessment of Muscle Tone</brief_title>
  <official_title>Stroke and Myotonometer: Validity, Reliability and Discrimination Between the Mechanical and Sensory Component of Spasticity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Seville</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Universitario Virgen Macarena</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospitales Universitarios Virgen del Rocío</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Seville</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Spasticity is defined as a state of increased muscle tone, which evokes an increased&#xD;
      resistance to a passive and fast stretching of the muscle. Indeed, the degree of spasticity&#xD;
      depends, among other things, on the stretching velocity performed to the muscle. However,&#xD;
      most of the tools used in the clinical setting to assess spasticity do not take into account&#xD;
      the relationship between increased muscle tone and speed of stretching. Instead of that,&#xD;
      muscle tone is usually assessed in a relaxed position of the muscle.&#xD;
&#xD;
      Likewise, to date, despite the functional disabilities related to the presence of chronic&#xD;
      pain after a stroke, no previous study has correlated muscle tone and pressure pain&#xD;
      sensitivity within this population&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2, 2019</start_date>
  <completion_date type="Actual">August 25, 2019</completion_date>
  <primary_completion_date type="Actual">August 25, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pressure Pain Threshold, assessed by Manual Pressure Algometry</measure>
    <time_frame>One time assessment</time_frame>
    <description>A handheld electronic pressure algometer with a 1-cm2 contact probe will be used. Pressure pain thresholds (PPTs), as the minimum necessary pressure force to evoke pain, will be assessed bilaterally over biceps brachii and the gastrocnemius muscles (medial and lateral). Assessments will be made using a topographical mapping covering myotendinous and muscle belly sites in the above mentioned muscles. A 30-second break will be used between assessments to prevent bruising, and an average of the two measures over each site will be calculated for the statistical analysis. Pressure algometry is reliable in healthy individuals, and in stroke patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Muscle Tone Assessment, using the modified Tardieu Scale</measure>
    <time_frame>One time assessment</time_frame>
    <description>The modified Tardieu Scale is the most common tool used in the clinical setting to evaluate the muscle tone. The muscle response to a slow and fast stretching will be performed. During the fast stretching, the joint angle in which the muscle responds with difficulty will be collected using an electrogoniometer.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Muscle Stiffness, assessed by a myotonometer</measure>
    <time_frame>One time assessment</time_frame>
    <description>The stiffness of the biceps brachii and gastrocnemius muscles will be collected using a handheld myotonometer device, the so-called MyotonPRO, (Myoton AS, Estonia). The MyotonPRO is small, non-invasive, and it has shown good validity and high reliability in larger and smaller body muscles. This device delivers a multi-scan mode of three brief mechanical impulses, each one shortly followed by a quick release, to record the damped natural oscillation of the muscle using an accelerometer.&#xD;
Evaluations will be made in the affected and non-affected sides of stroke patients and in dominant and non-dominant sides of control participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle State of Tension (Muscle Tone), assessed by a myotonometer</measure>
    <time_frame>One time assessment</time_frame>
    <description>The tone of the biceps brachii and gastrocnemius muscles will be collected using a handheld myotonometer device, the MyotonPRO, (Myoton AS, Estonia). The MyotonPRO is small, non-invasive, and it has shown good validity and high reliability in larger and smaller body muscles. This device delivers a multi-scan mode of three brief mechanical impulses, each one shortly followed by a quick release, to record the damped natural oscillation of the muscle using an accelerometer.&#xD;
Evaluations will be made in the affected and non-affected sides of stroke patients and in dominant and non-dominant sides of control participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle Thickness</measure>
    <time_frame>One time assessment</time_frame>
    <description>The thickness of the assessed muscles will be evaluated using ecography. Muscle thickness will be assessed in one point corresponding to a myotendinous site and one point corresponding to a muscle belly location in both, the biceps brachii and gastrocnemius muscles.&#xD;
Evaluations will be made in the affected and non-affected sides of stroke patients and in dominant and non-dominant sides of control participants.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">65</enrollment>
  <condition>Stroke</condition>
  <condition>Muscle Tone Abnormalities</condition>
  <condition>Pain</condition>
  <condition>Muscle Spasticity</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <description>A control group of healthy subjects with no previous history of neurological disorders or conditions. This group pf participants will be selected in a similar population based-cohort than the other two study groups.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acute Stroke Group</arm_group_label>
    <description>In this group, participants who suffered a previous stroke within 3 months before data collection will be included.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chronic Stroke Group</arm_group_label>
    <description>In this group, only participants who have suffered a previous stroke of more than 3 months duration before data collection will be included.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Assessment of Tone, Pain and Thickness</intervention_name>
    <description>Evaluation of Muscle state of tension, self-reported response to mechanical pressure pain and muscle thickness. The evaluation process of muscle tone and pressure pain sensitivity will be carried out following a topographical mapping covering myotendinous and muscle belly sites in the biceps brachii and the gastrocnemius muscles</description>
    <arm_group_label>Acute Stroke Group</arm_group_label>
    <arm_group_label>Chronic Stroke Group</arm_group_label>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants with acute or chronic stroke will be recruited from large public hospitals.&#xD;
        The control participants will be selected from the same population-based cohort&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be older than 18 years&#xD;
&#xD;
          -  Clinical diagnosis of stroke, confirmed using a MRI.&#xD;
&#xD;
          -  No previous history of other strokes.&#xD;
&#xD;
          -  Increases muscle tone in upper and lower extremities (punctuation equal to or superior&#xD;
             to 1 in the Tardieu Scale, Ashworth Scale)&#xD;
&#xD;
          -  Ability to understand the study goals, follow simple instructions and provide informed&#xD;
             consent.&#xD;
&#xD;
          -  Score equal to or superior to 24 in the Minimental State Examination.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any other confirmed neurological disorder that may influence muscle tone (multiple&#xD;
             sclerosis, Parkinson, muscle dystrophies...)&#xD;
&#xD;
          -  A chronic musculoskeletal disorder in the upper or lower limb.&#xD;
&#xD;
          -  Previous history of surgery in the upper or lower extremities.&#xD;
&#xD;
          -  Changes in the medication intake that may affect muscle tone assessments in the 48&#xD;
             hours before data collection.&#xD;
&#xD;
          -  Having received botulin toxin in gastrocnemius or biceps brachii muscles in the 30&#xD;
             days before data collection.&#xD;
&#xD;
          -  A concomitant acute infection during data collection.&#xD;
&#xD;
          -  A previous epileptic crisis in the week before the study or during the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Isabel Garcia Bernal, PT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Physiotherapy Department, University of Sevilla, Spain</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Sevilla</name>
      <address>
        <city>Sevilla</city>
        <zip>41009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Physiotherapy Department, University of Seville</name>
      <address>
        <city>Seville</city>
        <zip>41009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>January 21, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>September 19, 2019</last_update_submitted>
  <last_update_submitted_qc>September 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Seville</investigator_affiliation>
    <investigator_full_name>Alberto Marcos Heredia-Rizo</investigator_full_name>
    <investigator_title>Assistant Professor. Physiotherapy Department</investigator_title>
  </responsible_party>
  <keyword>Topographical mapping</keyword>
  <keyword>Muscle state of tension</keyword>
  <keyword>Myotonometer</keyword>
  <keyword>Pressure Pain Threshold</keyword>
  <keyword>Muscle Thickness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Spasticity</mesh_term>
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03814460
org study id: Myoton18
nct id: NCT03814460
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Spasticity is defined as a state of increased muscle tone, which evokes an increased
      resistance to a passive and fast stretching of the muscle. Indeed, the degree of spasticity
      depends, among other things, on the stretching velocity performed to the muscle. However,
      most of the tools used in the clinical setting to assess spasticity do not take into account
      the relationship between increased muscle tone and speed of stretching. Instead of that,
      muscle tone is usually assessed in a relaxed position of the muscle.

      Likewise, to date, despite the functional disabilities related to the presence of chronic
      pain after a stroke, no previous study has correlated muscle tone and pressure pain
      sensitivity within this population
observational model: Case-Control
time perspective: Prospective
measure: Pressure Pain Threshold, assessed by Manual Pressure Algometry
time frame: One time assessment
description: A handheld electronic pressure algometer with a 1-cm2 contact probe will be used. Pressure pain thresholds (PPTs), as the minimum necessary pressure force to evoke pain, will be assessed bilaterally over biceps brachii and the gastrocnemius muscles (medial and lateral). Assessments will be made using a topographical mapping covering myotendinous and muscle belly sites in the above mentioned muscles. A 30-second break will be used between assessments to prevent bruising, and an average of the two measures over each site will be calculated for the statistical analysis. Pressure algometry is reliable in healthy individuals, and in stroke patients
measure: Muscle Tone Assessment, using the modified Tardieu Scale
time frame: One time assessment
description: The modified Tardieu Scale is the most common tool used in the clinical setting to evaluate the muscle tone. The muscle response to a slow and fast stretching will be performed. During the fast stretching, the joint angle in which the muscle responds with difficulty will be collected using an electrogoniometer.
measure: Muscle Stiffness, assessed by a myotonometer
time frame: One time assessment
description: The stiffness of the biceps brachii and gastrocnemius muscles will be collected using a handheld myotonometer device, the so-called MyotonPRO, (Myoton AS, Estonia). The MyotonPRO is small, non-invasive, and it has shown good validity and high reliability in larger and smaller body muscles. This device delivers a multi-scan mode of three brief mechanical impulses, each one shortly followed by a quick release, to record the damped natural oscillation of the muscle using an accelerometer.
Evaluations will be made in the affected and non-affected sides of stroke patients and in dominant and non-dominant sides of control participants.
measure: Muscle State of Tension (Muscle Tone), assessed by a myotonometer
time frame: One time assessment
description: The tone of the biceps brachii and gastrocnemius muscles will be collected using a handheld myotonometer device, the MyotonPRO, (Myoton AS, Estonia). The MyotonPRO is small, non-invasive, and it has shown good validity and high reliability in larger and smaller body muscles. This device delivers a multi-scan mode of three brief mechanical impulses, each one shortly followed by a quick release, to record the damped natural oscillation of the muscle using an accelerometer.
Evaluations will be made in the affected and non-affected sides of stroke patients and in dominant and non-dominant sides of control participants.
measure: Muscle Thickness
time frame: One time assessment
description: The thickness of the assessed muscles will be evaluated using ecography. Muscle thickness will be assessed in one point corresponding to a myotendinous site and one point corresponding to a muscle belly location in both, the biceps brachii and gastrocnemius muscles.
Evaluations will be made in the affected and non-affected sides of stroke patients and in dominant and non-dominant sides of control participants.
arm group label: Control Group
description: A control group of healthy subjects with no previous history of neurological disorders or conditions. This group pf participants will be selected in a similar population based-cohort than the other two study groups.
arm group label: Acute Stroke Group
description: In this group, participants who suffered a previous stroke within 3 months before data collection will be included.
arm group label: Chronic Stroke Group
description: In this group, only participants who have suffered a previous stroke of more than 3 months duration before data collection will be included.
intervention type: Diagnostic Test
intervention name: Assessment of Tone, Pain and Thickness
description: Evaluation of Muscle state of tension, self-reported response to mechanical pressure pain and muscle thickness. The evaluation process of muscle tone and pressure pain sensitivity will be carried out following a topographical mapping covering myotendinous and muscle belly sites in the biceps brachii and the gastrocnemius muscles
arm group label: Acute Stroke Group
arm group label: Chronic Stroke Group
arm group label: Control Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Isabel Garcia Bernal, PT
role: Principal Investigator
affiliation: Physiotherapy Department, University of Sevilla, Spain
facility: 
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Seville
investigator full name: Alberto Marcos Heredia-Rizo
investigator title: Assistant Professor. Physiotherapy Department
mesh term: Muscle Spasticity
mesh term: Stroke
sharing ipd: Undecided