<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/NCT01694992</url>
  </required_header>
  <id_info>
    <org_study_id>11.0121</org_study_id>
    <nct_id>NCT01694992</nct_id>
  </id_info>
  <brief_title>Very Early Rehabilitation in Acute Ischemic Stroke</brief_title>
  <acronym>VERIS-Brazil</acronym>
  <official_title>Randomized Clinical Trial of Very Early Rehabilitation Compared With Conventional Rehabilitation in Acute Ischemic Stroke in the Vascular Unit of the Hospital de Clínicas de Porto Alegre - HCPA</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Clinicas de Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Clinicas de Porto Alegre</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effectiveness of a rehabilitation&#xD;
      (physiotherapy) program in patients with acute ischemic stroke in Acute Vascular Unit and in&#xD;
      general ward of Hospital de Clínicas de Porto Alegre, and to verify the degree of disability&#xD;
      at fourteenth and third month, functional improvement at third month, the frequency of deaths&#xD;
      and incidence of complications due to immobility and quantify the time spent in hospital.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2012</start_date>
  <completion_date type="Anticipated">August 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2012</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Disability</measure>
    <time_frame>three months</time_frame>
    <description>Outcome measure are assessed by Modified Rankin Scale. Good outcome was predefined as an mRS score of 0 to 2 and poor outcome of 3 to 6.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Minimum or no Disability</measure>
    <time_frame>three months</time_frame>
    <description>Measured by the modified Ranking Scale with score of 0 to 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Independence in activities of daily living</measure>
    <time_frame>three months</time_frame>
    <description>Measured by the modified Barthel Index, where score &lt; 75 indicate dependence and score &gt; 75 is independence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long of stay at hospital</measure>
    <time_frame>three month</time_frame>
    <description>Number of days in hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death</measure>
    <time_frame>three month</time_frame>
    <description>Determined by a blinded review of the clinical details by the investigators.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of complications</measure>
    <time_frame>three month</time_frame>
    <description>Number of complications (pneumonia and deep vein thrombosis) at three month</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">184</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Early mobilization</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Intervention Group - Early Mobilization - will follow the early physiotherapy program within the first 24 - 48 hours after stroke, five times per week for 30 plus a time spent out of bed (sitting).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The Control Group will follow within the routines of the hospital as is usually done.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Early mobilization</intervention_name>
    <description>The Intervention Group - Early Mobilization - will follow the early physiotherapy program within the first 24 - 48 hours after acute ischemic stroke, five times per week for 30 minutes plus time to spent out of bed (sitting).</description>
    <arm_group_label>Early mobilization</arm_group_label>
    <other_name>Early Physiotherapy Program</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with clinical diagnosis of acute ischemic stroke (first or recurrent)&#xD;
             confirmed by CCT or MRI admitted to the Acute Vascular Unit of HCPA between the first&#xD;
             48 hours of onset of symptoms.&#xD;
&#xD;
          -  Patients older than 18 years.&#xD;
&#xD;
          -  Patients clinically and hemodynamically stable (SBP 120-220 mmHg, SatO2 up to 92% with&#xD;
             or without supplementation, HR between 60 and 100 bmp, body temperature below 38 and&#xD;
             RR below 25 bpm).&#xD;
&#xD;
          -  Patients are able to react to verbal commands even without being fully alert (Glasgow&#xD;
             Scale above 8).&#xD;
&#xD;
          -  Prior Rankin until 3&#xD;
&#xD;
          -  Motor deficit and / or coordination measured by the NIHSS&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with clinical and / or hemodynamic instability&#xD;
&#xD;
          -  Patients with hemorrhagic stroke or TIA (transient ischemic attack).&#xD;
&#xD;
          -  Patients with progressive neurological disease and acute coronary disease and / or&#xD;
             unstable.&#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>Sheila CO Martins, Physician</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital de Clínicas de Porto Alegre (Hospital)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Simone RP Gobbato, Physiotherapist</last_name>
    <phone>55 51 9982 3387</phone>
    <email>sissipoletto@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sheila CO Martins, Physician</last_name>
    <phone>55 51 9962 8467</phone>
    <email>scmartins@hcpa.ufrgs.br</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital de Clínicas de Porto Alegre (Hospital)</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande do Sul</state>
        <zip>90035-903</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Simone RP Gobbato, Physiotherapist</last_name>
      <phone>55 51 9982 3387</phone>
      <email>sissipoletto@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Sheila CO Martins, Physician</last_name>
      <phone>55 51 9962 8467</phone>
      <email>scmartins@hcpa.ufrgs.br</email>
    </contact_backup>
    <investigator>
      <last_name>Simone RP Gobbato, Physiotherapist</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>September 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>September 25, 2012</last_update_submitted>
  <last_update_submitted_qc>September 25, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 27, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Early Ambulation</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Physical Therapy</keyword>
  <keyword>Randomized controlled trial</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/NCT01694992
org study id: 11.0121
nct id: NCT01694992
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the effectiveness of a rehabilitation
      (physiotherapy) program in patients with acute ischemic stroke in Acute Vascular Unit and in
      general ward of Hospital de Clínicas de Porto Alegre, and to verify the degree of disability
      at fourteenth and third month, functional improvement at third month, the frequency of deaths
      and incidence of complications due to immobility and quantify the time spent in hospital.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Disability
time frame: three months
description: Outcome measure are assessed by Modified Rankin Scale. Good outcome was predefined as an mRS score of 0 to 2 and poor outcome of 3 to 6.
measure: Minimum or no Disability
time frame: three months
description: Measured by the modified Ranking Scale with score of 0 to 1.
measure: Independence in activities of daily living
time frame: three months
description: Measured by the modified Barthel Index, where score < 75 indicate dependence and score > 75 is independence.
measure: Long of stay at hospital
time frame: three month
description: Number of days in hospital
measure: Death
time frame: three month
description: Determined by a blinded review of the clinical details by the investigators.
measure: Incidence of complications
time frame: three month
description: Number of complications (pneumonia and deep vein thrombosis) at three month
arm group label: Early mobilization
arm group type: Experimental
description: The Intervention Group - Early Mobilization - will follow the early physiotherapy program within the first 24 - 48 hours after stroke, five times per week for 30 plus a time spent out of bed (sitting).
arm group label: Control
arm group type: No Intervention
description: The Control Group will follow within the routines of the hospital as is usually done.
intervention type: Other
intervention name: Early mobilization
description: The Intervention Group - Early Mobilization - will follow the early physiotherapy program within the first 24 - 48 hours after acute ischemic stroke, five times per week for 30 minutes plus time to spent out of bed (sitting).
arm group label: Early mobilization
other name: Early Physiotherapy Program
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sheila CO Martins, Physician
role: Principal Investigator
affiliation: Hospital de Clínicas de Porto Alegre (Hospital)
last name: Simone RP Gobbato, Physiotherapist
phone: 55 51 9982 3387
email: sissipoletto@hotmail.com
last name: Sheila CO Martins, Physician
phone: 55 51 9962 8467
email: scmartins@hcpa.ufrgs.br
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Brazil
responsible party type: Sponsor
mesh term: Stroke
mesh term: Ischemic Stroke