<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/NCT01679600</url>
  </required_header>
  <id_info>
    <org_study_id>CardioRobot</org_study_id>
    <nct_id>NCT01679600</nct_id>
  </id_info>
  <brief_title>Cardiovascular Rehabilitation Early After Stroke Using Feedback-controlled Robotics-assisted Treadmill Exercise</brief_title>
  <official_title>Cardiovascular Rehabilitation Early After Stroke Using Feedback-controlled Robotics-assisted Treadmill Exercise: A Randomised Controlled Pilot Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bern University of Applied Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Maastricht University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Reha Rheinfelden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Swiss Federal Institute of Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bern University of Applied Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The propose of this study is to evaluate the feasibility and the clinical efficiency of&#xD;
      feedback-controlled robotics-assisted treadmill exercise (RATE) technology for cardiovascular&#xD;
      rehabilitation early after stroke. The investigators hypothesize that feedback-controlled&#xD;
      RATE might be suitable and effective to improve cardiovascular fitness and functional&#xD;
      carryover in non-ambulatory individuals with sub-acute stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For detailed info: Stoller O, de Bruin ED, Schuster-Amft C, Schindelholz M, de Bie RA, Hunt&#xD;
      KJ. Cardiovascular rehabilitation soon after stroke using feedback-controlled&#xD;
      robotics-assisted treadmill exercise: study protocol of a randomized controlled pilot trial.&#xD;
      Trials. 2013 Sep 22;14(1):304.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Peak Oxygen Uptake (V'O2peak)</measure>
    <time_frame>4 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Stroke</condition>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>FC-RATE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Feedback-controlled robotics-assisted treadmill exercise</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RATE</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Robotics-assisted treadmill exercise</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Feedback-controlled robotics-assisted treadmill exercise</intervention_name>
    <description>Progressive cardiovascular exercise using feedback-controlled robotics-assisted treadmill exercise. The first training session is defined to start at 40% of peak work rate (determined from a previous exercise test) to approach 40% of heart rate reserve (Borg scale approximately 11-14). The intensity will then be adjusted on the basis of continuous heart rate data and rating of perceived exertion indications by modulating the target work rate in 5% increments for every subsequent session to reach the target intensity. The target heart rate is set at 40% to 70% of heart rate reserve.</description>
    <arm_group_label>FC-RATE</arm_group_label>
    <other_name>Lokomat system (Hocoma AG, Volketswil, Switzerland)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Robotics-assisted treadmill exercise</intervention_name>
    <description>Conventional robotics-assisted treadmill exercise, where therapists focus on gait quality only.</description>
    <arm_group_label>RATE</arm_group_label>
    <other_name>Lokomat system (Hocoma AG, Volketswil, Switzerland)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of an initial supratentorial stroke&#xD;
&#xD;
          -  ≤20 weeks post stroke at intervention onset&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Functional Ambulation Category (FAC) ≤3&#xD;
&#xD;
          -  Ability to understand the procedures and provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications for exercise testing outlined by American College of Sports Medicine&#xD;
             (ACSM)&#xD;
&#xD;
          -  Contraindications for RATE according to the manufacturer&#xD;
&#xD;
          -  Concurrent neurological disease&#xD;
&#xD;
          -  Concurrent pulmonary disease&#xD;
&#xD;
          -  History of dementia&#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>Rob A. de Bie, Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Department of Epidemiology, Maastricht University and Caphri Research School, Maastricht, Netherlands</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kenneth J. Hunt, Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Institute for Rehabilitation and Performance Technology, Bern University of Applied Sciences, Burgdorf, Switzerland</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eling D. de Bruin, PD Dr.</last_name>
    <role>Study Director</role>
    <affiliation>Institute of Human Movement Sciences and Sport, ETH Zurich, Switzerland</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Thierry Ettlin, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Reha Rheinfelden, Rheinfelden, Switzerland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Reha Rheinfelden</name>
      <address>
        <city>Rheinfelden</city>
        <state>Aargau</state>
        <zip>4310</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <link>
    <url>http://irpt.ti.bfh.ch</url>
    <description>Institute for Rehabilitation and Performance Technology</description>
  </link>
  <link>
    <url>http://www.reha-rheinfelden.ch/</url>
    <description>Reha Rheinfelden</description>
  </link>
  <reference>
    <citation>Stoller O, de Bruin ED, Knols RH, Hunt KJ. Effects of cardiovascular exercise early after stroke: systematic review and meta-analysis. BMC Neurol. 2012 Jun 22;12:45. doi: 10.1186/1471-2377-12-45.</citation>
    <PMID>22727172</PMID>
  </reference>
  <reference>
    <citation>Stoller O, Schindelholz M, Bichsel L, Schuster C, de Bie RA, de Bruin ED, Hunt KJ. Feedback-controlled robotics-assisted treadmill exercise to assess and influence aerobic capacity early after stroke: a proof-of-concept study. Disabil Rehabil Assist Technol. 2014 Jul;9(4):271-8. doi: 10.3109/17483107.2013.785038. Epub 2013 Apr 18.</citation>
    <PMID>23597319</PMID>
  </reference>
  <reference>
    <citation>Stoller O, de Bruin ED, Schindelholz M, Schuster C, de Bie RA, Hunt KJ. Evaluation of exercise capacity after severe stroke using robotics-assisted treadmill exercise: a proof-of-concept study. Technol Health Care. 2013;21(2):157-66. doi: 10.3233/THC-130730.</citation>
    <PMID>23510976</PMID>
  </reference>
  <reference>
    <citation>Stoller O, de Bruin ED, Schuster-Amft C, Schindelholz M, de Bie RA, Hunt KJ. Cardiovascular rehabilitation soon after stroke using feedback-controlled robotics-assisted treadmill exercise: study protocol of a randomised controlled pilot trial. Trials. 2013 Sep 22;14:304. doi: 10.1186/1745-6215-14-304.</citation>
    <PMID>24053609</PMID>
  </reference>
  <results_reference>
    <citation>Stoller O, de Bruin ED, Schindelholz M, Schuster-Amft C, de Bie RA, Hunt KJ. Efficacy of Feedback-Controlled Robotics-Assisted Treadmill Exercise to Improve Cardiovascular Fitness Early After Stroke: A Randomized Controlled Pilot Trial. J Neurol Phys Ther. 2015 Jul;39(3):156-65. doi: 10.1097/NPT.0000000000000095.</citation>
    <PMID>26050073</PMID>
  </results_reference>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>September 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <results_first_submitted>July 3, 2015</results_first_submitted>
  <results_first_submitted_qc>July 30, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">August 5, 2015</results_first_posted>
  <last_update_submitted>July 30, 2015</last_update_submitted>
  <last_update_submitted_qc>July 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 5, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bern University of Applied Sciences</investigator_affiliation>
    <investigator_full_name>Oliver Stoller</investigator_full_name>
    <investigator_title>cand. PhD</investigator_title>
  </responsible_party>
  <keyword>Rehabilitation</keyword>
  <keyword>Robotics-assisted Treadmill Exercise</keyword>
  <keyword>Aerobic Capacity</keyword>
  <keyword>Exercise Testing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>6 subjects dropped out before assiggnment (abnormal gait pattern due to uncontrollable spasticity, tibia skin lesion due to inadequate padding during familiarization, lack of motivation to produce maximal work rate values, severe groin pain caused by the body weight support harness, suspected cerebrospinal fluid leak, acute respiratory infection)</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>FC-RATE</title>
          <description>Feedback-controlled robotics-assisted treadmill exercise&#xD;
Feedback-controlled robotics-assisted treadmill exercise: Human-in-the-loop feedback system to control individual's active work rate</description>
        </group>
        <group group_id="P2">
          <title>RATE</title>
          <description>Robotics-assisted treadmill exercise&#xD;
Robotics-assisted treadmill exercise: Conventional robotics-assisted treadmill exercise</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>FC-RATE</title>
          <description>Feedback-controlled robotics-assisted treadmill exercise&#xD;
Feedback-controlled robotics-assisted treadmill exercise: Human-in-the-loop feedback system to control individual's active work rate</description>
        </group>
        <group group_id="B2">
          <title>RATE</title>
          <description>Robotics-assisted treadmill exercise&#xD;
Robotics-assisted treadmill exercise: Conventional robotics-assisted treadmill exercise</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="7"/>
            <count group_id="B2" value="7"/>
            <count group_id="B3" value="14"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57" spread="12"/>
                    <measurement group_id="B2" value="63" spread="13"/>
                    <measurement group_id="B3" value="61" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Switzerland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Type of stroke: ischemic/hemorrhagic</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>ischemic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hemorrhagic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hemiparetic side: right/left</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>right</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>left</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Functional Ambulation Classification (0-5)</title>
          <description>Patients will be rated on the following 6 categories: 0: Patient cannot walk, or needs help from 2 or more persons. 1: Patients needs firm continuous support from 1 person who helps carrying weight and with balance. 2: Patient needs continuous or intermittent support of one person to help with balance and coordination. 3: Patient requires verbal supervision or stand-by help from one person without physical contact. 4: Patient can walk independently on level ground, but requires help on stairs, slopes or uneven surfaces. 5: Patient can walk independently anywhere.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1" spread="0.8"/>
                    <measurement group_id="B2" value="0.9" spread="1"/>
                    <measurement group_id="B3" value="1" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Time poststroke</title>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52" spread="42"/>
                    <measurement group_id="B2" value="45" spread="30"/>
                    <measurement group_id="B3" value="52" spread="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Peak Oxygen Uptake (V'O2peak)</title>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FC-RATE</title>
            <description>Feedback-controlled robotics-assisted treadmill exercise&#xD;
Feedback-controlled robotics-assisted treadmill exercise: Human-in-the-loop feedback system to control individual's active work rate</description>
          </group>
          <group group_id="O2">
            <title>RATE</title>
            <description>Robotics-assisted treadmill exercise&#xD;
Robotics-assisted treadmill exercise: Conventional robotics-assisted treadmill exercise</description>
          </group>
        </group_list>
        <measure>
          <title>Peak Oxygen Uptake (V'O2peak)</title>
          <units>mL/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1461" spread="683"/>
                    <measurement group_id="O2" value="1494" spread="672"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.53</p_value>
            <method>F1-LD-F1 model by Brunner and Langer</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>10/01/2012-03/31/2014</time_frame>
      <group_list>
        <group group_id="E1">
          <title>FC-RATE</title>
          <description>Feedback-controlled robotics-assisted treadmill exercise&#xD;
Feedback-controlled robotics-assisted treadmill exercise: Human-in-the-loop feedback system to control individual's active work rate</description>
        </group>
        <group group_id="E2">
          <title>RATE</title>
          <description>Robotics-assisted treadmill exercise&#xD;
Robotics-assisted treadmill exercise: Conventional robotics-assisted treadmill exercise</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Oliver Stoller</name_or_title>
      <organization>Bern University of Applied Sciences</organization>
      <phone>+41344264195</phone>
      <email>oliver.stoller@bfh.ch</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01679600
org study id: CardioRobot
nct id: NCT01679600
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The propose of this study is to evaluate the feasibility and the clinical efficiency of
      feedback-controlled robotics-assisted treadmill exercise (RATE) technology for cardiovascular
      rehabilitation early after stroke. The investigators hypothesize that feedback-controlled
      RATE might be suitable and effective to improve cardiovascular fitness and functional
      carryover in non-ambulatory individuals with sub-acute stroke.
For detailed info: Stoller O, de Bruin ED, Schuster-Amft C, Schindelholz M, de Bie RA, Hunt
      KJ. Cardiovascular rehabilitation soon after stroke using feedback-controlled
      robotics-assisted treadmill exercise: study protocol of a randomized controlled pilot trial.
      Trials. 2013 Sep 22;14(1):304.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Peak Oxygen Uptake (V'O2peak)
time frame: 4 weeks
arm group label: FC-RATE
arm group type: Experimental
description: Feedback-controlled robotics-assisted treadmill exercise
arm group label: RATE
arm group type: Active Comparator
description: Robotics-assisted treadmill exercise
intervention type: Device
intervention name: Feedback-controlled robotics-assisted treadmill exercise
description: Progressive cardiovascular exercise using feedback-controlled robotics-assisted treadmill exercise. The first training session is defined to start at 40% of peak work rate (determined from a previous exercise test) to approach 40% of heart rate reserve (Borg scale approximately 11-14). The intensity will then be adjusted on the basis of continuous heart rate data and rating of perceived exertion indications by modulating the target work rate in 5% increments for every subsequent session to reach the target intensity. The target heart rate is set at 40% to 70% of heart rate reserve.
arm group label: FC-RATE
other name: Lokomat system (Hocoma AG, Volketswil, Switzerland)
intervention type: Device
intervention name: Robotics-assisted treadmill exercise
description: Conventional robotics-assisted treadmill exercise, where therapists focus on gait quality only.
arm group label: RATE
other name: Lokomat system (Hocoma AG, Volketswil, Switzerland)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rob A. de Bie, Prof.
role: Study Director
affiliation: Department of Epidemiology, Maastricht University and Caphri Research School, Maastricht, Netherlands
last name: Kenneth J. Hunt, Prof.
role: Study Director
affiliation: Institute for Rehabilitation and Performance Technology, Bern University of Applied Sciences, Burgdorf, Switzerland
last name: Eling D. de Bruin, PD Dr.
role: Study Director
affiliation: Institute of Human Movement Sciences and Sport, ETH Zurich, Switzerland
last name: Thierry Ettlin, Prof.
role: Principal Investigator
affiliation: Reha Rheinfelden, Rheinfelden, Switzerland
facility: 
country: Switzerland
url: http://irpt.ti.bfh.ch
description: Institute for Rehabilitation and Performance Technology
url: http://www.reha-rheinfelden.ch/
description: Reha Rheinfelden
citation: Stoller O, de Bruin ED, Knols RH, Hunt KJ. Effects of cardiovascular exercise early after stroke: systematic review and meta-analysis. BMC Neurol. 2012 Jun 22;12:45. doi: 10.1186/1471-2377-12-45.
PMID: 22727172
citation: Stoller O, Schindelholz M, Bichsel L, Schuster C, de Bie RA, de Bruin ED, Hunt KJ. Feedback-controlled robotics-assisted treadmill exercise to assess and influence aerobic capacity early after stroke: a proof-of-concept study. Disabil Rehabil Assist Technol. 2014 Jul;9(4):271-8. doi: 10.3109/17483107.2013.785038. Epub 2013 Apr 18.
PMID: 23597319
citation: Stoller O, de Bruin ED, Schindelholz M, Schuster C, de Bie RA, Hunt KJ. Evaluation of exercise capacity after severe stroke using robotics-assisted treadmill exercise: a proof-of-concept study. Technol Health Care. 2013;21(2):157-66. doi: 10.3233/THC-130730.
PMID: 23510976
citation: Stoller O, de Bruin ED, Schuster-Amft C, Schindelholz M, de Bie RA, Hunt KJ. Cardiovascular rehabilitation soon after stroke using feedback-controlled robotics-assisted treadmill exercise: study protocol of a randomised controlled pilot trial. Trials. 2013 Sep 22;14:304. doi: 10.1186/1745-6215-14-304.
PMID: 24053609
citation: Stoller O, de Bruin ED, Schindelholz M, Schuster-Amft C, de Bie RA, Hunt KJ. Efficacy of Feedback-Controlled Robotics-Assisted Treadmill Exercise to Improve Cardiovascular Fitness Early After Stroke: A Randomized Controlled Pilot Trial. J Neurol Phys Ther. 2015 Jul;39(3):156-65. doi: 10.1097/NPT.0000000000000095.
PMID: 26050073
responsible party type: Principal Investigator
investigator affiliation: Bern University of Applied Sciences
investigator full name: Oliver Stoller
investigator title: cand. PhD
mesh term: Stroke
mesh term: Cardiovascular Diseases
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 