<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/NCT02974465</url>
  </required_header>
  <id_info>
    <org_study_id>UNIALCALA</org_study_id>
    <nct_id>NCT02974465</nct_id>
  </id_info>
  <brief_title>Electromyographic Biofeedback and Physical Therapy in Upper Limb Hemiparesis</brief_title>
  <acronym>EMG-BFB</acronym>
  <official_title>Electromyographic Biofeedback and Physical Therapy in Upper Limb Hemiparesis: A Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alcala</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alcala</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to assess the effect of a specific protocol of sEMG-BFB in upper&#xD;
      limb hemiparesis added to conventional physical therapy on changes in upper extremity&#xD;
      functionality, motor recruitment pattern and range of motion (ROM) compared to the single&#xD;
      application of conventional physical therapy. It aims to find a 22.22% difference between&#xD;
      both interventions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Upper limb hemiparesis is a common consequence after brain damage.&#xD;
&#xD;
      Objective: To evaluate the effect of a specific protocol of surface electromyographic&#xD;
      biofeedback (sEMG-BFB) and conventional physical therapy in upper limb functionality, muscle&#xD;
      recruitment changes, and glenohumeral range of motion compared to the single application of&#xD;
      conventional physical therapy.&#xD;
&#xD;
      Design: randomized controlled clinical trial.&#xD;
&#xD;
      Sample: 40 participants from State Center of Attention to Brain Injury were recruited.&#xD;
&#xD;
      Interventions: Patients were randomly assigned to 2 groups where the experimental group&#xD;
      received sEMG-BFB for the upper trapezius and middle deltoid muscles of the upper limb with&#xD;
      hemiparesis and the control group received a placebo of the same technique. Both treatments&#xD;
      were applied for 6 weeks. The score of the Fugl-Meyer Assessment-Upper Extremity&quot; for&#xD;
      functionality and shoulder range of motion were objectified. Root mean square (RMS) value was&#xD;
      assessed as a secondary measure Data were collected before and after intervention.&#xD;
&#xD;
      A protocol of sEMG-BFB in upper limb may have an important role in the recovery of subjects&#xD;
      with upper limb hemiparesis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">February 2018</completion_date>
  <primary_completion_date type="Actual">September 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>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fugl-Meyer Upper-Extremity Scale (FMA-UE)</measure>
    <time_frame>15 minutes</time_frame>
    <description>Assess functionality found in the motor recruitment of the paretic shoulder muscles after brain injury</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>range of motion</measure>
    <time_frame>10 minutes</time_frame>
    <description>Articular goniometer</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Electromyography</condition>
  <arm_group>
    <arm_group_label>Experimental Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>protocol of Biofeedback Electromyography plus conventional physical therapy treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>consisted of Sham- Biofeedback Electromyography plus conventional physical therapy treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Biofeedback Electromyography</intervention_name>
    <description>protocol of sEMG-BFB that consisted of active movements in glenohumeral abduction guided by the visual signal of the register equipment. The protocol was the following: firstly proof active movements were requested in glenohumeral abduction without feeling any pain in order to teach the visual signal of their muscle activity. The therapist dedicated around 10 minutes in each session for subject learned to control the activation of both muscles in the limits that physical therapist marked with each individual in particular (controlling the activation in the upper trapezius). Once integrated information, shoulder abduction were requested following 4 main principles.</description>
    <arm_group_label>Experimental Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sham Biofeedback Electromyography</intervention_name>
    <description>consisted of Sham-EMG biofeedback, in which the electrodes were placed as the same method as the EG (Fig. 2) but the screen emit no signal. The subject performed 3 sequences of 10 abduction contractions (first degrees) without pain feeling and with 5 minutes of rest between sequences.</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional Physical Therapy Treatment</intervention_name>
    <description>All participants received a conventional daily treatment of neurological physical therapy. Since no evidence has been found about a specific therapy that specially could benefit hemiparesis consequences, the common approach in this center consists of a combination of different specific concepts (Bobath, Brunnstrom, Rood, Johnstone, Propioceptive Neuromuscular Facilitation, Perfetti, Vojta, Motor Relearning Programme,…), exercise programs, electrotherapy, myofascial techniques, etc…</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Experimental Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  acquired brain injury after two months of medical evolution at least;&#xD;
&#xD;
          -  suffer paretic upper limb;&#xD;
&#xD;
          -  spasticity no greater than 3 in the modified Ashworth scale;&#xD;
&#xD;
          -  minimum active ROM of 20º of glenohumeral abduction.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  peripheral nerve injury, fractures of upper limb, cervical radiculopathy, complete&#xD;
             luxation of the shoulder and severe cognitive impairment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria Torres Lacomba, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Alcalá</affiliation>
  </overall_official>
  <reference>
    <citation>Dogan-Aslan M, Nakipoglu-Yuzer GF, Dogan A, Karabay I, Ozgirgin N. The effect of electromyographic biofeedback treatment in improving upper extremity functioning of patients with hemiplegic stroke. J Stroke Cerebrovasc Dis. 2012 Apr;21(3):187-92. doi: 10.1016/j.jstrokecerebrovasdis.2010.06.006. Epub 2010 Sep 29.</citation>
    <PMID>20880720</PMID>
  </reference>
  <reference>
    <citation>Giggins OM, Persson UM, Caulfield B. Biofeedback in rehabilitation. J Neuroeng Rehabil. 2013 Jun 18;10:60. doi: 10.1186/1743-0003-10-60.</citation>
    <PMID>23777436</PMID>
  </reference>
  <results_reference>
    <citation>De Baets L, Jaspers E, Janssens L, Van Deun S. Characteristics of neuromuscular control of the scapula after stroke: a first exploration. Front Hum Neurosci. 2014 Nov 17;8:933. doi: 10.3389/fnhum.2014.00933. eCollection 2014.</citation>
    <PMID>25477805</PMID>
  </results_reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 20, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <last_update_submitted>December 7, 2018</last_update_submitted>
  <last_update_submitted_qc>December 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alcala</investigator_affiliation>
    <investigator_full_name>Cristina Lirio Romero</investigator_full_name>
    <investigator_title>Physiotherapist</investigator_title>
  </responsible_party>
  <keyword>Brain injuries</keyword>
  <keyword>upper extremity</keyword>
  <keyword>biofeedback</keyword>
  <keyword>electromyography</keyword>
  <keyword>recovery of function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paresis</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/NCT02974465
org study id: UNIALCALA
nct id: NCT02974465
lead sponsor: 
has dmc: Yes
The aim of this study was to assess the effect of a specific protocol of sEMG-BFB in upper
      limb hemiparesis added to conventional physical therapy on changes in upper extremity
      functionality, motor recruitment pattern and range of motion (ROM) compared to the single
      application of conventional physical therapy. It aims to find a 22.22% difference between
      both interventions.
Upper limb hemiparesis is a common consequence after brain damage.

      Objective: To evaluate the effect of a specific protocol of surface electromyographic
      biofeedback (sEMG-BFB) and conventional physical therapy in upper limb functionality, muscle
      recruitment changes, and glenohumeral range of motion compared to the single application of
      conventional physical therapy.

      Design: randomized controlled clinical trial.

      Sample: 40 participants from State Center of Attention to Brain Injury were recruited.

      Interventions: Patients were randomly assigned to 2 groups where the experimental group
      received sEMG-BFB for the upper trapezius and middle deltoid muscles of the upper limb with
      hemiparesis and the control group received a placebo of the same technique. Both treatments
      were applied for 6 weeks. The score of the Fugl-Meyer Assessment-Upper Extremity" for
      functionality and shoulder range of motion were objectified. Root mean square (RMS) value was
      assessed as a secondary measure Data were collected before and after intervention.

      A protocol of sEMG-BFB in upper limb may have an important role in the recovery of subjects
      with upper limb hemiparesis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Fugl-Meyer Upper-Extremity Scale (FMA-UE)
time frame: 15 minutes
description: Assess functionality found in the motor recruitment of the paretic shoulder muscles after brain injury
measure: range of motion
time frame: 10 minutes
description: Articular goniometer
arm group label: Experimental Group
arm group type: Experimental
description: protocol of Biofeedback Electromyography plus conventional physical therapy treatment
arm group label: Control Group
arm group type: Sham Comparator
description: consisted of Sham- Biofeedback Electromyography plus conventional physical therapy treatment
intervention type: Procedure
intervention name: Biofeedback Electromyography
description: protocol of sEMG-BFB that consisted of active movements in glenohumeral abduction guided by the visual signal of the register equipment. The protocol was the following: firstly proof active movements were requested in glenohumeral abduction without feeling any pain in order to teach the visual signal of their muscle activity. The therapist dedicated around 10 minutes in each session for subject learned to control the activation of both muscles in the limits that physical therapist marked with each individual in particular (controlling the activation in the upper trapezius). Once integrated information, shoulder abduction were requested following 4 main principles.
arm group label: Experimental Group
intervention type: Procedure
intervention name: Sham Biofeedback Electromyography
description: consisted of Sham-EMG biofeedback, in which the electrodes were placed as the same method as the EG (Fig. 2) but the screen emit no signal. The subject performed 3 sequences of 10 abduction contractions (first degrees) without pain feeling and with 5 minutes of rest between sequences.
arm group label: Control Group
intervention type: Procedure
intervention name: Conventional Physical Therapy Treatment
description: All participants received a conventional daily treatment of neurological physical therapy. Since no evidence has been found about a specific therapy that specially could benefit hemiparesis consequences, the common approach in this center consists of a combination of different specific concepts (Bobath, Brunnstrom, Rood, Johnstone, Propioceptive Neuromuscular Facilitation, Perfetti, Vojta, Motor Relearning Programme,…), exercise programs, electrotherapy, myofascial techniques, etc…
arm group label: Control Group
arm group label: Experimental Group
criteria: 
gender: All
minimum age: 15 Years
maximum age: 55 Years
healthy volunteers: No
last name: Maria Torres Lacomba, PhD
role: Study Director
affiliation: University of Alcalá
citation: Dogan-Aslan M, Nakipoglu-Yuzer GF, Dogan A, Karabay I, Ozgirgin N. The effect of electromyographic biofeedback treatment in improving upper extremity functioning of patients with hemiplegic stroke. J Stroke Cerebrovasc Dis. 2012 Apr;21(3):187-92. doi: 10.1016/j.jstrokecerebrovasdis.2010.06.006. Epub 2010 Sep 29.
PMID: 20880720
citation: Giggins OM, Persson UM, Caulfield B. Biofeedback in rehabilitation. J Neuroeng Rehabil. 2013 Jun 18;10:60. doi: 10.1186/1743-0003-10-60.
PMID: 23777436
citation: De Baets L, Jaspers E, Janssens L, Van Deun S. Characteristics of neuromuscular control of the scapula after stroke: a first exploration. Front Hum Neurosci. 2014 Nov 17;8:933. doi: 10.3389/fnhum.2014.00933. eCollection 2014.
PMID: 25477805
responsible party type: Principal Investigator
investigator affiliation: University of Alcala
investigator full name: Cristina Lirio Romero
investigator title: Physiotherapist
mesh term: Paresis
sharing ipd: No