<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/NCT03753984</url>
  </required_header>
  <id_info>
    <org_study_id>UNIVAP</org_study_id>
    <nct_id>NCT03753984</nct_id>
  </id_info>
  <brief_title>Effects of Low-level Laser Therapy in the Fatigue Muscle of Healthy Individual and Spastic Individuals</brief_title>
  <official_title>Analysis of the Effects of Low-level Laser Therapy in the Muscular Fadiga of the Braquial Biceps Muscle of Healthy Individual and Spastic Individuals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade do Vale do Paraíba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade do Vale do Paraíba</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>
      Muscle fatigue is caused by biochemical changes that modify the mechanics of muscle&#xD;
      contraction, which result in negative changes in the performance of the contraction. The&#xD;
      objective of this study is to evaluate the effects of LLLT on brachial biceps muscle fatigue&#xD;
      in healthy individuals and individuals with spastic hemiparesis. The study will consist of&#xD;
      three groups (Control Group, Placebo Group and LLLT Group) and all individuals will go&#xD;
      through all groups, following the criteria of randomization. The protocol consists of LLLT&#xD;
      application in the dominant side brachialis muscle in healthy subjects and on the hemiparetic&#xD;
      side of post-stroke individuals, prior to performing the Isometric Maximum Voluntary&#xD;
      Contraction (IMVC) for 50 seconds in the isokinetic dynamometer. Will be evaluated pain,&#xD;
      myoelectric activity associated with muscular torque, local temperature and blood lactate&#xD;
      concentration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Muscle fatigue is caused by biochemical changes that modify the mechanics of muscle&#xD;
      contraction, which result in negative changes in the performance of the contraction. Several&#xD;
      resources are studied in order to mitigate this situation, among them we can mention the Low&#xD;
      Level-Laser Therapy (LLLT), which has demonstrated positive effects in the treatment of&#xD;
      muscle disorders and fatigue prevention. The effects of LLLT are being studied in healthy&#xD;
      individuals with fibromyalgia and athletes, currently studies are being performed on spastic&#xD;
      muscles with post-stroke patients (post-stroke). The objective of this study is to evaluate&#xD;
      the effects of LLLT on brachial biceps muscle fatigue in healthy individuals and individuals&#xD;
      with spastic hemiparesis. A double-blind, cross-sectional, comparative, randomized,&#xD;
      double-blind clinical trial will be conducted. Phase I will consist of 30 healthy individuals&#xD;
      and Phase II will be composed of 30 post-stroke individuals. The study will consist of three&#xD;
      groups (Control Group, Placebo Group and LLLT Group) and all individuals will go through all&#xD;
      groups, following the criteria of randomization. The protocol consists of LLLT application in&#xD;
      the dominant side brachialis muscle in healthy subjects and on the hemiparetic side of&#xD;
      post-stroke individuals, prior to performing the Isometric Maximum Voluntary Contraction&#xD;
      (IMVC) for 50 seconds in the isokinetic dynamometer. The pain intensity will be evaluated&#xD;
      through the Visual Analog Pain Scale, the myoelectric activity through the surface&#xD;
      electromyography associated with the evaluation of the muscular torque through the isokinetic&#xD;
      dynamometer. The local temperature will be evaluated by infrared thermography and blood&#xD;
      lactate concentration by means of the lactimeter, which will be measured at four different&#xD;
      times, prior to the application of the laser (basal collection) and 3, 15 and 25 minutes&#xD;
      after IMVC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Anticipated">March 1, 2020</completion_date>
  <primary_completion_date type="Actual">June 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in pain sensation</measure>
    <time_frame>Baseline (before test) and will be assessed from the beginning to the end of the test (50 seconds).</time_frame>
    <description>To analize the pain. The scale is composed of a horizontal line with a scale of 0 to 10, with 0 representing no pain and 10 representing the worst possible pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Surface electromyograph</measure>
    <time_frame>Will be assessed from the beginning to the end of the test (50 seconds).</time_frame>
    <description>To analize the myoelectric activity. The surface electrodes will be placed in pairs on the muscular belly of the biceps and triceps brachii muscles, following the longitudinal direction of the muscle fibers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Analyze the behavior of the local temperature (Infra-red thermography)</measure>
    <time_frame>Baseline (Before test) and will be assessed from the beginning to the end of the test (50 seconds).</time_frame>
    <description>To analize the local temperature.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To evaluate changes in lactate concentration through lactimeter.</measure>
    <time_frame>Baseline (before test) and after the test (3, 15 and 25 minutes after the test)</time_frame>
    <description>A collection of blood lactate levels will be performed at four different times.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Isokinetic dynamometer</measure>
    <time_frame>Will be assessed from the beginning to the end of the test (50 seconds).</time_frame>
    <description>To analize muscle torque</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Fatigue</condition>
  <condition>Stroke Sequelae</condition>
  <arm_group>
    <arm_group_label>Healthy group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The protocol consists of Low-level laser therapy (LLLT) application in the dominant side brachialis muscle in healthy subjects prior to performing the Isometric Maximum Voluntary Contraction (IMVC) for 50 seconds in the isokinetic dynamometer and will be analize Visual Analog Pain Scale, electromyography associated with the evaluation of the muscular torque through the isokinetic dynamometer, local infrared thermography and blood lactate concentration by means of the lactimeter, which will be measured at four different times, prior to the application of the laser (basal collection) and 3, 15 and 25 minutes after IMVC. All the participants will pass for three groups: Control group (not will be applicate LLLT), Placebo group (laser will be off) and LLLT group (will be applicate LLLT).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Post stroke group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The protocol consists of Low-level laser therapy (LLLT) application in the hemiparetic side brachialis muscle post stroke individuals prior to performing the Isometric Maximum Voluntary Contraction (IMVC) for 50 seconds in the isokinetic dynamometer and will be analize Visual Analog Pain Scale, surface electromyography with the evaluation of the muscular torque through the isokinetic dynamometer, local infrared thermography and blood lactate concentration, which will be measured at four different times, prior to the application of the laser (basal collection) and 3, 15 and 25 minutes after IMVC. All the participants will pass for three groups: Control group (not will be applicate LLLT), Placebo group (laser will be off) and LLLT group (will be applicate LLLT).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low-level laser therapy</intervention_name>
    <description>In both arms will be applied Low-level laser therapy and induced muscle fatigue.</description>
    <arm_group_label>Healthy group</arm_group_label>
    <arm_group_label>Post stroke group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        -  Inclusion Criteria (Healthy group):&#xD;
&#xD;
               -  Preserved cognition, and preservation of the ability to respond to verbal stimul;&#xD;
&#xD;
               -  To present the &quot;insufficient active&quot; or &quot;active&quot; indices on the scale of the&#xD;
                  International Questionnaire of Physical Activity.&#xD;
&#xD;
          -  Inclusion Criteria (Post stroke group):&#xD;
&#xD;
               -  Individuals with medical diagnosis of stroke;&#xD;
&#xD;
               -  Individuals with physiotherapeutic diagnosis of spastic hemiparesis with brachial&#xD;
                  predominance;&#xD;
&#xD;
               -  Preserved cognition and preservation of the ability to respond to verbal stimuli;&#xD;
&#xD;
               -  Injury time: after 12 months;&#xD;
&#xD;
               -  Patients with a maximum of 2 degree spasticity according to the Modified Ashworth&#xD;
                  Scale and minimum muscle strength of 1 in the biceps brachii muscle.&#xD;
&#xD;
          -  Exclusion Criteria (Healthy group):&#xD;
&#xD;
               -  Possess musculoskeletal impairment of the dominant upper limb;&#xD;
&#xD;
               -  Practice physical activity with load (bodybuilding);&#xD;
&#xD;
               -  Presence of active infection and eruptions in the dominant upper limb;&#xD;
&#xD;
               -  Limiting pain that makes it impossible to perform the evaluation protocol;&#xD;
&#xD;
               -  Ingestion of analgesic and / or anti-inflammatory drugs and / or drugs containing&#xD;
                  corticosteroids or steroids.&#xD;
&#xD;
               -  Fitzpatrick classification: Phototypes V and VI;&#xD;
&#xD;
               -  Presence of malignant neoplastic lesion;&#xD;
&#xD;
               -  Presence of active infection and eruptions at the electrode application site;&#xD;
&#xD;
               -  Hypoesthesia and / or hyperesthesia and / or anesthesia of the limb in which TLBI&#xD;
                  will be applied.&#xD;
&#xD;
          -  Exclusion Criteria (Healthy group):&#xD;
&#xD;
               -  Presence of active infection and eruptions in the dominant upper limb;&#xD;
&#xD;
               -  Limiting pain that makes it impossible to perform the evaluation protocol;&#xD;
&#xD;
               -  Ingestion of analgesic and / or anti-inflammatory drugs and / or drugs containing&#xD;
                  corticosteroids or steroids.&#xD;
&#xD;
               -  Fitzpatrick classification: Phototypes V and VI;&#xD;
&#xD;
               -  Presence of malignant neoplastic lesion;&#xD;
&#xD;
               -  Presence of active infection and eruptions at the electrode application site;&#xD;
&#xD;
               -  Hypoesthesia and / or hyperesthesia and / or anesthesia of the limb to be&#xD;
                  treated;&#xD;
&#xD;
               -  Muscular contractures and joint deformities;&#xD;
&#xD;
               -  Uncontrolled arterial hypertension;&#xD;
&#xD;
               -  Individuals with other associated neurological and / or orthopedic disorders;&#xD;
&#xD;
               -  Wernick or Broca's aphasia.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fernanda P Lima, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade do Vale do Paraíba</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gabriela S Souza</last_name>
    <phone>5512997232806</phone>
    <email>gabrielasouza507@yahoo.com.br</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Gabriela S Souza</last_name>
    <phone>5512997232806</phone>
    <email>fpupio@univap.br</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Universidade do Vale do Paraiba</name>
      <address>
        <city>São José Dos Campos</city>
        <state>São Paulo</state>
        <zip>12.244-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gabriela S Souza</last_name>
      <phone>5512997232806</phone>
      <email>gabrielasouza507@yahoo.com.br</email>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>October 31, 2018</study_first_submitted>
  <study_first_submitted_qc>November 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>July 12, 2019</last_update_submitted>
  <last_update_submitted_qc>July 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fatigue</keyword>
  <keyword>Low-level Laser Therapy</keyword>
  <keyword>Stroke</keyword>
  <keyword>Infrared thermograpy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03753984
org study id: UNIVAP
nct id: NCT03753984
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Muscle fatigue is caused by biochemical changes that modify the mechanics of muscle
      contraction, which result in negative changes in the performance of the contraction. The
      objective of this study is to evaluate the effects of LLLT on brachial biceps muscle fatigue
      in healthy individuals and individuals with spastic hemiparesis. The study will consist of
      three groups (Control Group, Placebo Group and LLLT Group) and all individuals will go
      through all groups, following the criteria of randomization. The protocol consists of LLLT
      application in the dominant side brachialis muscle in healthy subjects and on the hemiparetic
      side of post-stroke individuals, prior to performing the Isometric Maximum Voluntary
      Contraction (IMVC) for 50 seconds in the isokinetic dynamometer. Will be evaluated pain,
      myoelectric activity associated with muscular torque, local temperature and blood lactate
      concentration.
Muscle fatigue is caused by biochemical changes that modify the mechanics of muscle
      contraction, which result in negative changes in the performance of the contraction. Several
      resources are studied in order to mitigate this situation, among them we can mention the Low
      Level-Laser Therapy (LLLT), which has demonstrated positive effects in the treatment of
      muscle disorders and fatigue prevention. The effects of LLLT are being studied in healthy
      individuals with fibromyalgia and athletes, currently studies are being performed on spastic
      muscles with post-stroke patients (post-stroke). The objective of this study is to evaluate
      the effects of LLLT on brachial biceps muscle fatigue in healthy individuals and individuals
      with spastic hemiparesis. A double-blind, cross-sectional, comparative, randomized,
      double-blind clinical trial will be conducted. Phase I will consist of 30 healthy individuals
      and Phase II will be composed of 30 post-stroke individuals. The study will consist of three
      groups (Control Group, Placebo Group and LLLT Group) and all individuals will go through all
      groups, following the criteria of randomization. The protocol consists of LLLT application in
      the dominant side brachialis muscle in healthy subjects and on the hemiparetic side of
      post-stroke individuals, prior to performing the Isometric Maximum Voluntary Contraction
      (IMVC) for 50 seconds in the isokinetic dynamometer. The pain intensity will be evaluated
      through the Visual Analog Pain Scale, the myoelectric activity through the surface
      electromyography associated with the evaluation of the muscular torque through the isokinetic
      dynamometer. The local temperature will be evaluated by infrared thermography and blood
      lactate concentration by means of the lactimeter, which will be measured at four different
      times, prior to the application of the laser (basal collection) and 3, 15 and 25 minutes
      after IMVC.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Changes in pain sensation
time frame: Baseline (before test) and will be assessed from the beginning to the end of the test (50 seconds).
description: To analize the pain. The scale is composed of a horizontal line with a scale of 0 to 10, with 0 representing no pain and 10 representing the worst possible pain.
measure: Surface electromyograph
time frame: Will be assessed from the beginning to the end of the test (50 seconds).
description: To analize the myoelectric activity. The surface electrodes will be placed in pairs on the muscular belly of the biceps and triceps brachii muscles, following the longitudinal direction of the muscle fibers.
measure: Analyze the behavior of the local temperature (Infra-red thermography)
time frame: Baseline (Before test) and will be assessed from the beginning to the end of the test (50 seconds).
description: To analize the local temperature.
measure: To evaluate changes in lactate concentration through lactimeter.
time frame: Baseline (before test) and after the test (3, 15 and 25 minutes after the test)
description: A collection of blood lactate levels will be performed at four different times.
measure: Isokinetic dynamometer
time frame: Will be assessed from the beginning to the end of the test (50 seconds).
description: To analize muscle torque
arm group label: Healthy group
arm group type: Experimental
description: The protocol consists of Low-level laser therapy (LLLT) application in the dominant side brachialis muscle in healthy subjects prior to performing the Isometric Maximum Voluntary Contraction (IMVC) for 50 seconds in the isokinetic dynamometer and will be analize Visual Analog Pain Scale, electromyography associated with the evaluation of the muscular torque through the isokinetic dynamometer, local infrared thermography and blood lactate concentration by means of the lactimeter, which will be measured at four different times, prior to the application of the laser (basal collection) and 3, 15 and 25 minutes after IMVC. All the participants will pass for three groups: Control group (not will be applicate LLLT), Placebo group (laser will be off) and LLLT group (will be applicate LLLT).
arm group label: Post stroke group
arm group type: Experimental
description: The protocol consists of Low-level laser therapy (LLLT) application in the hemiparetic side brachialis muscle post stroke individuals prior to performing the Isometric Maximum Voluntary Contraction (IMVC) for 50 seconds in the isokinetic dynamometer and will be analize Visual Analog Pain Scale, surface electromyography with the evaluation of the muscular torque through the isokinetic dynamometer, local infrared thermography and blood lactate concentration, which will be measured at four different times, prior to the application of the laser (basal collection) and 3, 15 and 25 minutes after IMVC. All the participants will pass for three groups: Control group (not will be applicate LLLT), Placebo group (laser will be off) and LLLT group (will be applicate LLLT).
intervention type: Other
intervention name: Low-level laser therapy
description: In both arms will be applied Low-level laser therapy and induced muscle fatigue.
arm group label: Healthy group
arm group label: Post stroke group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Fernanda P Lima, Doctor
role: Principal Investigator
affiliation: Universidade do Vale do Paraíba
last name: Gabriela S Souza
phone: 5512997232806
email: gabrielasouza507@yahoo.com.br
last name: Gabriela S Souza
phone: 5512997232806
email: fpupio@univap.br
facility: 
status: Recruiting
contact: 
country: Brazil
responsible party type: Sponsor
mesh term: Fatigue
sharing ipd: No