<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/NCT02255708</url>
  </required_header>
  <id_info>
    <org_study_id>U1111-1161-5560</org_study_id>
    <nct_id>NCT02255708</nct_id>
  </id_info>
  <brief_title>Effects of an Intervention Program by Proprioceptive Neuromuscular Facilitation, in Muscle Force Irradiation.</brief_title>
  <official_title>Electromyography Evaluation of the Stabilizing Muscles of the Scapula and Tibial Anterior Muscle, After an Intervention Program by Proprioceptive Neuromuscular Facilitation in Muscle Force Irradiation.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present study aims to assess through surface electromyography, the effectiveness of&#xD;
      proprioceptive neuromuscular facilitation protocols in the activation of the stabilizing&#xD;
      muscles of the scapula and the anterior tibial muscle.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Healthy subjects and subjects with demyelinating polyneuropathy are involved in the study.&#xD;
&#xD;
      Healthy patients are arranged in two groups of stimulation: FNP Group (intervention&#xD;
      proprioceptive neuromuscular facilitation) - CC Group (intervention classic cinesioterapia).&#xD;
      The electromyographic response of the stabilizing muscles of the scapula of each individual&#xD;
      will be assessed prior to application of the protocols, during the execution of the protocols&#xD;
      and immediately after stopping in a single session.&#xD;
&#xD;
      Patients with demyelinating polyneuropathy are arranged in a single treatment group and will&#xD;
      be treated at a frequency of twice a week for five weeks. In each session, the PNF patterns&#xD;
      will be repeated four times, on both sides, stimulating muscle irradiation and evoking the&#xD;
      contraction of the tibialis anterior muscle. During the repetition of the patterns, the&#xD;
      dorsiflexor muscle response of each patient will be obtained by an electromyography (EMG)&#xD;
      surface.&#xD;
&#xD;
      The data of the RMS values obtained in the first session will be normalized and transformed&#xD;
      into percentage. The average RMS of each diagonal at the beginning of treatment corresponds&#xD;
      to 100% of TA muscle activation. The RMS values obtained in the last session will be&#xD;
      normalized as a percentage, taking into account the results of the first evaluation. After&#xD;
      normalization, data from the first and last sessions will besubjected to the for paired&#xD;
      t-test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <primary_completion_date type="Anticipated">August 2015</primary_completion_date>
  <phase>Phase 1</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of muscle force irradiation, through surface electromyography.</measure>
    <time_frame>This evaluation of patients is performed in only one day, being made before, during and after the application of the protocols. It is estimated that the results are collected in one years.</time_frame>
    <description>Irradiation of muscle strength will be assessed using surface electromyography, which shows the activation or not of the muscles evaluated.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Assessment of Muscle Force Irradiation</condition>
  <arm_group>
    <arm_group_label>Healthy group.</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Group formed by healthy patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group with demyelinating polyneuropathy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Group formed by patients with demyelinating polyneuropathy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Proprioceptive Neuromuscular Facilitation - PNF</intervention_name>
    <arm_group_label>Group with demyelinating polyneuropathy</arm_group_label>
    <arm_group_label>Healthy group.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Healthy individuals group: who agree to participate in the study with no history of&#xD;
        previous trauma or disease of the shoulder girdle, with absence of clinical signs painful&#xD;
        in the shoulder joint.&#xD;
&#xD;
        Group with demyelinating polyneuropathy: both sexes, carriers of CMT-1A disease with&#xD;
        functional changes in the lower limbs with good cognition and difficulty of to ambulate&#xD;
        with and without assistance.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Healthy individuals group: subject with restricted range of motion, muscle weakness,&#xD;
        cognitive impairment, which exhibits a pathology that leads to alterations in muscle&#xD;
        recruitment.&#xD;
&#xD;
        Patients with polyneuropathy: cardiac arrhythmias, uncontrolled hypertension, severe&#xD;
        cardiovascular disease and respiratory problems. The use of own medicines to treat&#xD;
        pathology was accepted.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ana Cláudia S Ferreira, graduate student</last_name>
    <phone>+55-16 988027661</phone>
    <phone_ext>0740</phone_ext>
    <email>acsilvaf35@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>João Eduardo Araujo, lecturer</last_name>
    <phone>+55-16-6024416</phone>
    <phone_ext>0740</phone_ext>
    <email>araujoje@fmrp.usp.br</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Laboratory of Neuropsychobiology and Motor Behavior,</name>
      <address>
        <city>Ribeirão Preto</city>
        <state>São Paulo</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ana Cláudia s Ferreira, graduate student</last_name>
      <phone>+55-16-988027661</phone>
      <email>acsilvaf35@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>João Eduardo Araujo, lecturer</last_name>
      <phone>+55-16-6024416</phone>
      <email>araujoje@fmrp.usp.br</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>September 29, 2014</last_update_submitted>
  <last_update_submitted_qc>September 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 2, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Ana Cláudia Silva Ferreira</investigator_full_name>
    <investigator_title>Ana Cláudia Silva Ferreira</investigator_title>
  </responsible_party>
  <!-- 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/NCT02255708
org study id: U1111-1161-5560
nct id: NCT02255708
lead sponsor: 
has dmc: No
The present study aims to assess through surface electromyography, the effectiveness of
      proprioceptive neuromuscular facilitation protocols in the activation of the stabilizing
      muscles of the scapula and the anterior tibial muscle.
Healthy subjects and subjects with demyelinating polyneuropathy are involved in the study.

      Healthy patients are arranged in two groups of stimulation: FNP Group (intervention
      proprioceptive neuromuscular facilitation) - CC Group (intervention classic cinesioterapia).
      The electromyographic response of the stabilizing muscles of the scapula of each individual
      will be assessed prior to application of the protocols, during the execution of the protocols
      and immediately after stopping in a single session.

      Patients with demyelinating polyneuropathy are arranged in a single treatment group and will
      be treated at a frequency of twice a week for five weeks. In each session, the PNF patterns
      will be repeated four times, on both sides, stimulating muscle irradiation and evoking the
      contraction of the tibialis anterior muscle. During the repetition of the patterns, the
      dorsiflexor muscle response of each patient will be obtained by an electromyography (EMG)
      surface.

      The data of the RMS values obtained in the first session will be normalized and transformed
      into percentage. The average RMS of each diagonal at the beginning of treatment corresponds
      to 100% of TA muscle activation. The RMS values obtained in the last session will be
      normalized as a percentage, taking into account the results of the first evaluation. After
      normalization, data from the first and last sessions will besubjected to the for paired
      t-test.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Evaluation of muscle force irradiation, through surface electromyography.
time frame: This evaluation of patients is performed in only one day, being made before, during and after the application of the protocols. It is estimated that the results are collected in one years.
description: Irradiation of muscle strength will be assessed using surface electromyography, which shows the activation or not of the muscles evaluated.
arm group label: Healthy group.
arm group type: Other
description: Group formed by healthy patients.
arm group label: Group with demyelinating polyneuropathy
arm group type: Other
description: Group formed by patients with demyelinating polyneuropathy.
intervention type: Other
intervention name: Proprioceptive Neuromuscular Facilitation - PNF
arm group label: Group with demyelinating polyneuropathy
arm group label: Healthy group.
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ana Cláudia S Ferreira, graduate student
phone: +55-16 988027661
phone ext: 0740
email: acsilvaf35@gmail.com
last name: João Eduardo Araujo, lecturer
phone: +55-16-6024416
phone ext: 0740
email: araujoje@fmrp.usp.br
facility: 
status: Recruiting
contact: 
contact backup: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Ana Cláudia Silva Ferreira
investigator title: Ana Cláudia Silva Ferreira