<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/NCT02209922</url>
  </required_header>
  <id_info>
    <org_study_id>tDCS and postural control</org_study_id>
    <secondary_id>15840</secondary_id>
    <nct_id>NCT02209922</nct_id>
  </id_info>
  <brief_title>The Effects of tDCS Combined With Balance Training on Postural Control in Chronic Stroke Patients</brief_title>
  <official_title>The Effects of tDCS Combined With Balance Training on Postural Control in Chronic Stroke Patients ( A Randomized Controlled Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shahid Beheshti University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shahid Beheshti University of Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose:&#xD;
&#xD;
      The incidence of stroke in low-to-middle income countries is increasing .Balance impairment&#xD;
      and falling negatively impact function of stroke patients. Mobility is based on successful&#xD;
      postural control and about 30% of individuals with stroke are unable to ambulate without&#xD;
      assistance.Transcranial direct current stimulation (tDCS) is a new promising tool for motor&#xD;
      recovery in neurological disease.This can be addressed through a tDCS intervention.&#xD;
&#xD;
      Objective:The objectives of this study is to examine the efficacy of anodal tDCS combined&#xD;
      with Biodex balance training on postural control in chronic stroke patients using laboratory&#xD;
      and clinical assessments. The following essential treatment components; a) active tDCS&#xD;
      stimulation paired with Biodex balance training, b)sham tDCS paired with Biodex balance&#xD;
      training program.&#xD;
&#xD;
      To identify combinations effects of tDCS stimulation plus balance training . Hypothesis:&#xD;
      Anodal tDCS targeting leg motor area (CZ) for 5-days plus Biodex balance training, will&#xD;
      significantly improve stroke clients' balance and functional mobility.&#xD;
&#xD;
      Double blinded sham -controlled randomized tDCS stimulation Arms Assigned Interventions&#xD;
&#xD;
      Experimental: Arm 1&#xD;
&#xD;
      tDCS brain stimulation and simultaneous balance training&#xD;
&#xD;
      Participants underwent Active tDCS brain stimulation (20 minutes) and simultaneous balance&#xD;
      training(20 minutes) for 5 consecutive days.&#xD;
&#xD;
      No Intervention: Arm 2 Sham tDCS brain stimulation (20 minutes) and simultaneous balance&#xD;
      training&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants underwent tDCS(2mA) brain stimulation (20 minutes) and simultaneous balance&#xD;
      training(20 minutes) for 5 consecutive days, All outcome measures will be measured in 4 time&#xD;
      points: pre-test, post-test after 10 sessions of intervention, and after 1 week and 1 months&#xD;
      post intervention as follow ups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2014</start_date>
  <completion_date type="Anticipated">August 2017</completion_date>
  <primary_completion_date type="Anticipated">August 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, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postural control</measure>
    <time_frame>After 5 days</time_frame>
    <description>Functional dynamic balance</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Static Balance</measure>
    <time_frame>After 5 days</time_frame>
    <description>linear analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Static Balance</measure>
    <time_frame>1 week</time_frame>
    <description>linear analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Static Balance</measure>
    <time_frame>1 month</time_frame>
    <description>linear analysis</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Postural sway flactuation</measure>
    <time_frame>After 5 days</time_frame>
    <description>nonlinear (Approximate entropy) analysis</description>
  </other_outcome>
  <other_outcome>
    <measure>Postural sway flactuation</measure>
    <time_frame>1 week</time_frame>
    <description>nonlinear (Approximate entropy) analysis</description>
  </other_outcome>
  <other_outcome>
    <measure>Postural sway flactuation</measure>
    <time_frame>1 month</time_frame>
    <description>nonlinear (Approximate entropy) analysis</description>
  </other_outcome>
  <other_outcome>
    <measure>Change of Postural control</measure>
    <time_frame>1 week</time_frame>
    <description>Functional dynamic balance</description>
  </other_outcome>
  <other_outcome>
    <measure>Change of Postural control</measure>
    <time_frame>1 month</time_frame>
    <description>Functional dynamic balance</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Ischemic Stroke</condition>
  <arm_group>
    <arm_group_label>Transcranial direct current stimulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ARM1: Transcranial direct current stimulation (tDCS) intervention and simultaneous balance training.&#xD;
Participants underwent tDCS(2mA) brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days,for 1 week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ARM 2</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>ARM2: Sham tDCS and simultaneous balance training(20 minutes) for 5 consecutive days,for 1 week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcranial direct current stimulation (tDCS)</intervention_name>
    <description>Participants underwent tDCS(2mA) brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days,for 1 week.</description>
    <arm_group_label>Transcranial direct current stimulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham</intervention_name>
    <description>During sham stimulation, the current ramped up for 30 seconds, ramped back down for 30 seconds, and then remained off for the duration of the stimulation then and simultaneous balance training(20 minutes) for 5 consecutive days,for 1 week.</description>
    <arm_group_label>ARM 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        age ≥18 years; first-ever ischemic stroke; chronic phase of recovery (&gt;6 months); ability&#xD;
        to walk 6- meter supported or unsupported; ability to stand at least unsupported for&#xD;
        40-seconds with eyes closed; only ischemic stroke involving middle cerebral artery (MCA)&#xD;
        territory confirmed by CT or MRI.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Use of any neuro- or psycho-active medications that alters balance; any other neurological&#xD;
        conditions or sensory disorders affecting postural control; such as brain tumor, or&#xD;
        substance abuse; orthopedic diseases; ongoing/recent (within 3 months) balance&#xD;
        rehabilitation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fariba Yadolahi, MD-MPH-PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Physical therapy-School of Rehabilitation-Shahid Beheshti University of Medical sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Fariba Yadolahi, MD-PhD Candidate</last_name>
    <phone>00989109564012</phone>
    <email>fariba.yadolahi@sbmu.ac.ir</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shahid Beheshti Univesity of Medical sciences</name>
      <address>
        <city>Tehran</city>
        <zip>1616931111</zip>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fariba Yadolahi, MD-MPH-PhD</last_name>
      <phone>+989109564012</phone>
      <email>fariba.yadolahi@sbmu.ac.ir</email>
    </contact>
    <investigator>
      <last_name>Fariba Yadolahi, MD-MPH-PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 30, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>July 22, 2017</last_update_submitted>
  <last_update_submitted_qc>July 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shahid Beheshti University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Fariba Yadolahi</investigator_full_name>
    <investigator_title>Fariba Yadolahi-MD-MPH-PhD Candidate in physical therapy</investigator_title>
  </responsible_party>
  <keyword>tDCS, stroke, postural control</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
  </condition_browse>
  <!-- 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/NCT02209922
org study id: tDCS and postural control
secondary id: 15840
nct id: NCT02209922
lead sponsor: 
has dmc: Yes
Purpose:

      The incidence of stroke in low-to-middle income countries is increasing .Balance impairment
      and falling negatively impact function of stroke patients. Mobility is based on successful
      postural control and about 30% of individuals with stroke are unable to ambulate without
      assistance.Transcranial direct current stimulation (tDCS) is a new promising tool for motor
      recovery in neurological disease.This can be addressed through a tDCS intervention.

      Objective:The objectives of this study is to examine the efficacy of anodal tDCS combined
      with Biodex balance training on postural control in chronic stroke patients using laboratory
      and clinical assessments. The following essential treatment components; a) active tDCS
      stimulation paired with Biodex balance training, b)sham tDCS paired with Biodex balance
      training program.

      To identify combinations effects of tDCS stimulation plus balance training . Hypothesis:
      Anodal tDCS targeting leg motor area (CZ) for 5-days plus Biodex balance training, will
      significantly improve stroke clients' balance and functional mobility.

      Double blinded sham -controlled randomized tDCS stimulation Arms Assigned Interventions

      Experimental: Arm 1

      tDCS brain stimulation and simultaneous balance training

      Participants underwent Active tDCS brain stimulation (20 minutes) and simultaneous balance
      training(20 minutes) for 5 consecutive days.

      No Intervention: Arm 2 Sham tDCS brain stimulation (20 minutes) and simultaneous balance
      training
Participants underwent tDCS(2mA) brain stimulation (20 minutes) and simultaneous balance
      training(20 minutes) for 5 consecutive days, All outcome measures will be measured in 4 time
      points: pre-test, post-test after 10 sessions of intervention, and after 1 week and 1 months
      post intervention as follow ups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Postural control
time frame: After 5 days
description: Functional dynamic balance
measure: Static Balance
time frame: After 5 days
description: linear analysis
measure: Change of Static Balance
time frame: 1 week
description: linear analysis
measure: Change of Static Balance
time frame: 1 month
description: linear analysis
measure: Postural sway flactuation
time frame: After 5 days
description: nonlinear (Approximate entropy) analysis
measure: Postural sway flactuation
time frame: 1 week
description: nonlinear (Approximate entropy) analysis
measure: Postural sway flactuation
time frame: 1 month
description: nonlinear (Approximate entropy) analysis
measure: Change of Postural control
time frame: 1 week
description: Functional dynamic balance
measure: Change of Postural control
time frame: 1 month
description: Functional dynamic balance
arm group label: Transcranial direct current stimulation
arm group type: Active Comparator
description: ARM1: Transcranial direct current stimulation (tDCS) intervention and simultaneous balance training.
Participants underwent tDCS(2mA) brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days,for 1 week.
arm group label: ARM 2
arm group type: Sham Comparator
description: ARM2: Sham tDCS and simultaneous balance training(20 minutes) for 5 consecutive days,for 1 week.
intervention type: Device
intervention name: Transcranial direct current stimulation (tDCS)
description: Participants underwent tDCS(2mA) brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days,for 1 week.
arm group label: Transcranial direct current stimulation
intervention type: Device
intervention name: Sham
description: During sham stimulation, the current ramped up for 30 seconds, ramped back down for 30 seconds, and then remained off for the duration of the stimulation then and simultaneous balance training(20 minutes) for 5 consecutive days,for 1 week.
arm group label: ARM 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Fariba Yadolahi, MD-MPH-PhD
role: Principal Investigator
affiliation: Department of Physical therapy-School of Rehabilitation-Shahid Beheshti University of Medical sciences
last name: Fariba Yadolahi, MD-PhD Candidate
phone: 00989109564012
email: fariba.yadolahi@sbmu.ac.ir
facility: 
status: Recruiting
contact: 
investigator: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: Shahid Beheshti University of Medical Sciences
investigator full name: Fariba Yadolahi
investigator title: Fariba Yadolahi-MD-MPH-PhD Candidate in physical therapy
mesh term: Stroke
mesh term: Ischemic Stroke