<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/NCT03838809</url>
  </required_header>
  <id_info>
    <org_study_id>UCAM/UITA/03</org_study_id>
    <nct_id>NCT03838809</nct_id>
  </id_info>
  <brief_title>Electromyography-biofeedback on the Motor Activation of the Extension of the Hand</brief_title>
  <acronym>EMGBIO-ICTUS</acronym>
  <official_title>Effect of a Neurological Physiotherapy Program With Electromyography-biofeedback on the Motor Activation of the Extension of the Hand and Dorsiflexion of the Foot in Cerebrovascular Damage: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Católica San Antonio de Murcia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Católica San Antonio de Murcia</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>
      Background: Biofeedback-Surface electromyography (BIO-SEMG) is a relatively recent&#xD;
      physiotherapy technique. Although its use is widespread in sports science and sports&#xD;
      performance, its use for the rehabilitation of patients with neurological pathologies is less&#xD;
      studied.&#xD;
&#xD;
      Objective: The purpose of this research was to determine the changes that occur in the&#xD;
      application of BIO-SEMG in the muscles responsible for the extension and the dorsiflexion of&#xD;
      the hand and the foot in subjects with cerebrovascular damage.&#xD;
&#xD;
      Design: A randomized, double-blind, two-arm parallel group study was performed.&#xD;
&#xD;
      Patients: A sample of 28 subjects with limited extension of the hand and dorsiflexion of the&#xD;
      foot as a consequence of a stroke was randomized divided in intervention or control groups.&#xD;
&#xD;
      Methods: The subjects of the intervention group underwent 12 sessions of BIO-SEMG, of&#xD;
      15-minute duration each of them, in the upper and lower members. On the other hand, the&#xD;
      control group underwent another 12 sessions of 15-minute duration, in which manual&#xD;
      physiotherapy techniques were performed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 8, 2017</start_date>
  <completion_date type="Actual">June 1, 2018</completion_date>
  <primary_completion_date type="Actual">November 30, 2017</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>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Extension Degree</measure>
    <time_frame>3 months</time_frame>
    <description>Change in the extension ability of the upper an lower members depending on the activity of the extensor muscles</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fugl Meyer Test</measure>
    <time_frame>6 months</time_frame>
    <description>Severity degree of the stroke-derived consequences</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Stroke, Complication</condition>
  <arm_group>
    <arm_group_label>INTERVENTION</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A group that underwent a neurological physiotherapy program with electromyography-biofeedback on the hand and the foot</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CONTROL</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A group that underwent a conventional physiotheraphy intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>surface electromyography-biofeedback</intervention_name>
    <description>Two electrodes were putted on the motor point of the extensor muscle of the hand and the foot. The positive electrode was placed on the distal zone of the hand or the foot, while the negative electrode was placed on the proximal zone.</description>
    <arm_group_label>CONTROL</arm_group_label>
    <arm_group_label>INTERVENTION</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a stroke&#xD;
&#xD;
          -  Limitation of the hand and foot extension&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with some contraindication against the surface electromyography biofeedback&#xD;
             technique, for instance, people with pacemaker, with cardiovascular antecedents, etc.&#xD;
&#xD;
          -  Patients receiving other physiotherapy treatment 2 months before the beginning of the&#xD;
             study&#xD;
&#xD;
          -  Patients that decline to sign the informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>74 Years</minimum_age>
    <maximum_age>84 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Juan José Hernández Morante, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Catholic University of Murcia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Catholic University of Murcia</name>
      <address>
        <city>Murcia</city>
        <zip>30107</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>February 9, 2019</last_update_submitted>
  <last_update_submitted_qc>February 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Católica San Antonio de Murcia</investigator_affiliation>
    <investigator_full_name>Juan Jose Hernández Morante</investigator_full_name>
    <investigator_title>Principal Investigator of the Eating Disorders Research Unit</investigator_title>
  </responsible_party>
  <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/NCT03838809
org study id: UCAM/UITA/03
nct id: NCT03838809
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: Biofeedback-Surface electromyography (BIO-SEMG) is a relatively recent
      physiotherapy technique. Although its use is widespread in sports science and sports
      performance, its use for the rehabilitation of patients with neurological pathologies is less
      studied.

      Objective: The purpose of this research was to determine the changes that occur in the
      application of BIO-SEMG in the muscles responsible for the extension and the dorsiflexion of
      the hand and the foot in subjects with cerebrovascular damage.

      Design: A randomized, double-blind, two-arm parallel group study was performed.

      Patients: A sample of 28 subjects with limited extension of the hand and dorsiflexion of the
      foot as a consequence of a stroke was randomized divided in intervention or control groups.

      Methods: The subjects of the intervention group underwent 12 sessions of BIO-SEMG, of
      15-minute duration each of them, in the upper and lower members. On the other hand, the
      control group underwent another 12 sessions of 15-minute duration, in which manual
      physiotherapy techniques were performed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: Extension Degree
time frame: 3 months
description: Change in the extension ability of the upper an lower members depending on the activity of the extensor muscles
measure: Fugl Meyer Test
time frame: 6 months
description: Severity degree of the stroke-derived consequences
arm group label: INTERVENTION
arm group type: Experimental
description: A group that underwent a neurological physiotherapy program with electromyography-biofeedback on the hand and the foot
arm group label: CONTROL
arm group type: Active Comparator
description: A group that underwent a conventional physiotheraphy intervention
intervention type: Device
intervention name: surface electromyography-biofeedback
description: Two electrodes were putted on the motor point of the extensor muscle of the hand and the foot. The positive electrode was placed on the distal zone of the hand or the foot, while the negative electrode was placed on the proximal zone.
arm group label: CONTROL
arm group label: INTERVENTION
criteria: 
gender: All
minimum age: 74 Years
maximum age: 84 Years
healthy volunteers: No
last name: Juan José Hernández Morante, PhD
role: Principal Investigator
affiliation: Catholic University of Murcia
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad Católica San Antonio de Murcia
investigator full name: Juan Jose Hernández Morante
investigator title: Principal Investigator of the Eating Disorders Research Unit
sharing ipd: No