<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/NCT02995616</url>
  </required_header>
  <id_info>
    <org_study_id>LOKOMAT STUDY II</org_study_id>
    <nct_id>NCT02995616</nct_id>
  </id_info>
  <brief_title>Energy Consumption and Cardiorespiratory Load During Robot-Assisted Gait Training in Non-Ambulatory Stroke Patients</brief_title>
  <official_title>Energy Consumption and Cardiorespiratory Load During Robot-Assisted Gait Training in Non-Ambulatory Stroke Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vrije Universiteit Brussel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vrije Universiteit Brussel</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>
      The aim of this study will be to investigate the energy consumption, cardiorespiratory load&#xD;
      and perceived exertion in non-ambulatory subacute stroke patients during a robot-assisted&#xD;
      gait training (RAGT) session and to compare the exercise intensity with aerobic training&#xD;
      recommendations.&#xD;
&#xD;
      The second aim is to investigate the effect of different levels of guidance force on the&#xD;
      energy consumption, cardiorespiratory load and perceived exertion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      STUDY DESIGN. An experimental, 1-group, single-centre trial will be conducted in which stroke&#xD;
      patients will perform 2 RAGT sessions: 1) walking in the Lokomat according to regular RAGT&#xD;
      settings and 2) walking in the Lokomat with different levels of guidance force (60%, 80% and&#xD;
      100%).&#xD;
&#xD;
      PATIENT RECRUITMENT. We aim to recruit 20 stroke patients in the St. Ursula Rehabilitation&#xD;
      Centre in Herk-de-Stad, Belgium.&#xD;
&#xD;
      RESTRICTIONS AND PROHIBITIONS. Patients will be instructed to not consume food, alcohol,&#xD;
      caffeine or nicotine at least 3h prior to the intervention. Usual medication intake will be&#xD;
      allowed with small amounts of water.&#xD;
&#xD;
      PROCEDURE. Patients will be tested in 3 RAGT sessions on 3 separate days. During the first&#xD;
      session patients will walk in the Lokomat according to their regular therapy settings for a&#xD;
      minimum of 20 minutes (i.e. minimum tolerable guidance force (GF), minimal tolerable body&#xD;
      weight support (BWS) and maximum tolerable walking speed). During the second and third&#xD;
      session patients will walk in the Lokomat with 2 different levels of guidance force (once 60%&#xD;
      and once 100%) for a minimum 20 minutes each and with the same amount of body weight support&#xD;
      and walking speed as in the first session. On a separate day before the intervention,&#xD;
      patients will be seated for 10 minutes during which resting values (respiratory gases and&#xD;
      heart rate) will be assessed (in order to measure their Resting Metabolic Rate). In addition,&#xD;
      informed consent and baseline clinical demographic characteristics will be obtained. At the&#xD;
      start of the intervention, a mouth mask, heart rate monitor and gait analysis system will be&#xD;
      applied. After a seated resting period of 5 minutes, patients will walk for a minimum of 20&#xD;
      minutes during which respiratory gases and heart rate will be monitored continuously. The&#xD;
      Borg rating of perceived exertion will be registered every 3 minutes. The intervention will&#xD;
      be terminated early when relative or absolute indications are presented as reported by the&#xD;
      American Heart Association or when patients are unable to continue walking. Walking sessions&#xD;
      will be controlled for time of day.&#xD;
&#xD;
      RANDOMIZATION. The levels of GF will be randomised..&#xD;
&#xD;
      MATERIALS. A flexible facemask (adult facemask, small/medium, Cortex, Germany), lightweight&#xD;
      chest carrying gas analysis system (Metamax 3B, Cortex, Germany) and Bluetooth heart rate&#xD;
      belt (Polar H7, Polar Electro, Finland) will be used to measure metabolic and&#xD;
      cardiorespiratory parameters. At the start of each measurement, gas (room air and reference&#xD;
      gas (17.4% O2 and 5.1% CO2)) and volume (3L syringe) calibrations of the breath-by-breath gas&#xD;
      analysis system will be performed in accordance with the manufacturer's instructions.&#xD;
&#xD;
      STATISTICAL ANALYSIS. Statistics will be performed using SPSS (IBM, Chicago, IL). The&#xD;
      significance level will be set at 5%. Descriptive statistics will be calculated for baseline&#xD;
      patient characteristics. Means and standard deviations will be calculated for continuous&#xD;
      variables and frequencies and percentages for categorical variables. To investigate the&#xD;
      effect of time and the effect of different levels of guidance force, repeated measures ANOVAs&#xD;
      (within subject factors) will be analyzed. In case of significant differences, posthoc&#xD;
      analysis will be interpreted. To investigate if the effect of guidance force is related to&#xD;
      the patient's baseline level of GF (i.e. GF during regular therapy settings) correlational&#xD;
      analysis will be performed and baseline GF will be considered as a covariate.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 16, 2017</start_date>
  <completion_date type="Actual">January 8, 2019</completion_date>
  <primary_completion_date type="Actual">January 8, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Oxygen consumption (VO2)</measure>
    <time_frame>End 5min resting period; Begin, mid and end of 20min walking period (session 1, 2 and 3)</time_frame>
    <description>Average oxygen consumption (mL/kg/min) at different time frames. Oxygen consumption will be measured continuously (from the beginning of rest till the end of walking). Offline calculations (e.g. averages) will be performed afterwards.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Carbon Dioxide Production (CO2)</measure>
    <time_frame>End 5min resting period; Begin, mid and end of 20min walking period (session 1, 2 and 3)</time_frame>
    <description>Average carbon dioxide production (mL/kg/min) at different time frames. Carbon dioxide production will be measured continuously (from the beginning of rest till the end of walking). Offline calculations (e.g. averages) will be performed afterwards.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Minute ventilation (VE)</measure>
    <time_frame>End 5min resting period; Begin, mid and end of 20min walking period (session 1, 2 and 3)</time_frame>
    <description>Average amount of air in- or exhaled (L/min) at different time frames. VE will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart rate (HR)</measure>
    <time_frame>End 5min resting period; Begin, mid and end of 20min walking period (session 1, 2 and 3)</time_frame>
    <description>Average heart rate (beats/min) at different time frames. Heart rate will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage heart rate reserve (%HRR)</measure>
    <time_frame>Begin, mid and end of 20min walking period (session 1)</time_frame>
    <description>The percentage of the heart rate reserve (i.e. the difference between the person's predicted maximum heart rate and the person's resting heart rate) at different time moments (= heart rate at different times moments divided by predicted heart rate reserve).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage maximal heart rate (%HRmax)</measure>
    <time_frame>Begin, mid and end of 20min walking period (session 1)</time_frame>
    <description>The percentage of the person's predicted maximal heart rate at different time moments (= heart rate at different times moments divided by predicted maximal heart rate).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rating of perceived exertion (assessed by the 6-20 Borg scale) (RPE)</measure>
    <time_frame>End 5min resting period; Begin, mid and end of 20min walking period (session 1, 2 and 3)</time_frame>
    <description>Rating of perceived effort, strain and/or fatigue during walking, pointed on a 15-point Borg scale (6-20) at the end of rest and during walking (every 3 minutes).</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Lokomat training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be tested in 3 Lokomat training sessions on 3 separate days. During the first session patients will walk in the Lokomat according to their regular therapy settings. During the second and third session patients will walk in the Lokomat with 2 different levels of guidance force (100% guidance force and 60% guidance force).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Regular therapy settings</intervention_name>
    <description>Patients will walk in the Lokomat according to their regular therapy settings for a minimum of 20 minutes (i.e. minimum tolerable guidance force (GF), minimal tolerable body weight support (BWS) and maximum tolerable walking speed)</description>
    <arm_group_label>Lokomat training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>100% guidance force</intervention_name>
    <description>Patients will walk in the Lokomat with 100% GF for a minimum of 20 minutes (same amount of body weight support and walking speed as in the first session)</description>
    <arm_group_label>Lokomat training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>60% guidance force</intervention_name>
    <description>Patients will walk in the Lokomat with 60% GF for a minimum of 20 minutes (same amount of body weight support and walking speed as in the first session)</description>
    <arm_group_label>Lokomat training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  First-ever subacute (≤ 3 months) stroke patients&#xD;
&#xD;
          -  Eligible to receive robot-assisted gait training according to local therapists'&#xD;
             criteria (i.e. non-ambulatory stroke patients that are able to bear full weight on the&#xD;
             hemiplegic leg during a minimum of one gait cycle with manual help allowed to maintain&#xD;
             balance)&#xD;
&#xD;
          -  Functional Ambulation Category &lt; 3&#xD;
&#xD;
          -  Trained in the Lokomat system 2 times prior to the start of the study (i.e. one&#xD;
             fitting session and one training session).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &gt; 135 kg and &gt;179 cm&#xD;
&#xD;
          -  Unstable cardiovascular conditions&#xD;
&#xD;
          -  Musculoskeletal problems (other than stroke) affecting the ability to walk&#xD;
&#xD;
          -  Concurrent pulmonary diseases (e.g. asthma)&#xD;
&#xD;
          -  Concurrent neurological diseases&#xD;
&#xD;
          -  Communicative and/or cognitive problems affecting the ability to comprehend or follow&#xD;
             instructions&#xD;
&#xD;
          -  Other problems affecting the execution of the intervention (e.g. severe spasticity,&#xD;
             contractures or dermatological contra-indications)&#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>Eric Kerckhofs, Prof. Ph.D</last_name>
    <role>Study Chair</role>
    <affiliation>Vrije Universiteit Brussel</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eva Swinnen, Prof. Ph.D</last_name>
    <role>Study Director</role>
    <affiliation>Vrije Universiteit Brussel</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nina Lefeber, Ph.D student</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vrije Universiteit Brussel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Ursula Rehabilitation Centre (Jessa Hospital)</name>
      <address>
        <city>Herk-de-Stad</city>
        <state>Limburg</state>
        <zip>3540</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>February 5, 2019</last_update_submitted>
  <last_update_submitted_qc>February 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vrije Universiteit Brussel</investigator_affiliation>
    <investigator_full_name>Nina Lefeber</investigator_full_name>
    <investigator_title>Doctoral Researcher</investigator_title>
  </responsible_party>
  <keyword>Robot-Assisted Gait Training</keyword>
  <keyword>Guidance force</keyword>
  <keyword>Stroke</keyword>
  <keyword>Energy Consumption</keyword>
  <keyword>Cardiorespiratory Load</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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/NCT02995616
org study id: LOKOMAT STUDY II
nct id: NCT02995616
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study will be to investigate the energy consumption, cardiorespiratory load
      and perceived exertion in non-ambulatory subacute stroke patients during a robot-assisted
      gait training (RAGT) session and to compare the exercise intensity with aerobic training
      recommendations.

      The second aim is to investigate the effect of different levels of guidance force on the
      energy consumption, cardiorespiratory load and perceived exertion.
STUDY DESIGN. An experimental, 1-group, single-centre trial will be conducted in which stroke
      patients will perform 2 RAGT sessions: 1) walking in the Lokomat according to regular RAGT
      settings and 2) walking in the Lokomat with different levels of guidance force (60%, 80% and
      100%).

      PATIENT RECRUITMENT. We aim to recruit 20 stroke patients in the St. Ursula Rehabilitation
      Centre in Herk-de-Stad, Belgium.

      RESTRICTIONS AND PROHIBITIONS. Patients will be instructed to not consume food, alcohol,
      caffeine or nicotine at least 3h prior to the intervention. Usual medication intake will be
      allowed with small amounts of water.

      PROCEDURE. Patients will be tested in 3 RAGT sessions on 3 separate days. During the first
      session patients will walk in the Lokomat according to their regular therapy settings for a
      minimum of 20 minutes (i.e. minimum tolerable guidance force (GF), minimal tolerable body
      weight support (BWS) and maximum tolerable walking speed). During the second and third
      session patients will walk in the Lokomat with 2 different levels of guidance force (once 60%
      and once 100%) for a minimum 20 minutes each and with the same amount of body weight support
      and walking speed as in the first session. On a separate day before the intervention,
      patients will be seated for 10 minutes during which resting values (respiratory gases and
      heart rate) will be assessed (in order to measure their Resting Metabolic Rate). In addition,
      informed consent and baseline clinical demographic characteristics will be obtained. At the
      start of the intervention, a mouth mask, heart rate monitor and gait analysis system will be
      applied. After a seated resting period of 5 minutes, patients will walk for a minimum of 20
      minutes during which respiratory gases and heart rate will be monitored continuously. The
      Borg rating of perceived exertion will be registered every 3 minutes. The intervention will
      be terminated early when relative or absolute indications are presented as reported by the
      American Heart Association or when patients are unable to continue walking. Walking sessions
      will be controlled for time of day.

      RANDOMIZATION. The levels of GF will be randomised..

      MATERIALS. A flexible facemask (adult facemask, small/medium, Cortex, Germany), lightweight
      chest carrying gas analysis system (Metamax 3B, Cortex, Germany) and Bluetooth heart rate
      belt (Polar H7, Polar Electro, Finland) will be used to measure metabolic and
      cardiorespiratory parameters. At the start of each measurement, gas (room air and reference
      gas (17.4% O2 and 5.1% CO2)) and volume (3L syringe) calibrations of the breath-by-breath gas
      analysis system will be performed in accordance with the manufacturer's instructions.

      STATISTICAL ANALYSIS. Statistics will be performed using SPSS (IBM, Chicago, IL). The
      significance level will be set at 5%. Descriptive statistics will be calculated for baseline
      patient characteristics. Means and standard deviations will be calculated for continuous
      variables and frequencies and percentages for categorical variables. To investigate the
      effect of time and the effect of different levels of guidance force, repeated measures ANOVAs
      (within subject factors) will be analyzed. In case of significant differences, posthoc
      analysis will be interpreted. To investigate if the effect of guidance force is related to
      the patient's baseline level of GF (i.e. GF during regular therapy settings) correlational
      analysis will be performed and baseline GF will be considered as a covariate.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Oxygen consumption (VO2)
time frame: End 5min resting period; Begin, mid and end of 20min walking period (session 1, 2 and 3)
description: Average oxygen consumption (mL/kg/min) at different time frames. Oxygen consumption will be measured continuously (from the beginning of rest till the end of walking). Offline calculations (e.g. averages) will be performed afterwards.
measure: Carbon Dioxide Production (CO2)
time frame: End 5min resting period; Begin, mid and end of 20min walking period (session 1, 2 and 3)
description: Average carbon dioxide production (mL/kg/min) at different time frames. Carbon dioxide production will be measured continuously (from the beginning of rest till the end of walking). Offline calculations (e.g. averages) will be performed afterwards.
measure: Minute ventilation (VE)
time frame: End 5min resting period; Begin, mid and end of 20min walking period (session 1, 2 and 3)
description: Average amount of air in- or exhaled (L/min) at different time frames. VE will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards.
measure: Heart rate (HR)
time frame: End 5min resting period; Begin, mid and end of 20min walking period (session 1, 2 and 3)
description: Average heart rate (beats/min) at different time frames. Heart rate will be measured continuously (from the beginning of rest till the end of the walking session). Offline calculations will be performed afterwards.
measure: Percentage heart rate reserve (%HRR)
time frame: Begin, mid and end of 20min walking period (session 1)
description: The percentage of the heart rate reserve (i.e. the difference between the person's predicted maximum heart rate and the person's resting heart rate) at different time moments (= heart rate at different times moments divided by predicted heart rate reserve).
measure: Percentage maximal heart rate (%HRmax)
time frame: Begin, mid and end of 20min walking period (session 1)
description: The percentage of the person's predicted maximal heart rate at different time moments (= heart rate at different times moments divided by predicted maximal heart rate).
measure: Rating of perceived exertion (assessed by the 6-20 Borg scale) (RPE)
time frame: End 5min resting period; Begin, mid and end of 20min walking period (session 1, 2 and 3)
description: Rating of perceived effort, strain and/or fatigue during walking, pointed on a 15-point Borg scale (6-20) at the end of rest and during walking (every 3 minutes).
arm group label: Lokomat training
arm group type: Experimental
description: Patients will be tested in 3 Lokomat training sessions on 3 separate days. During the first session patients will walk in the Lokomat according to their regular therapy settings. During the second and third session patients will walk in the Lokomat with 2 different levels of guidance force (100% guidance force and 60% guidance force).
intervention type: Device
intervention name: Regular therapy settings
description: Patients will walk in the Lokomat according to their regular therapy settings for a minimum of 20 minutes (i.e. minimum tolerable guidance force (GF), minimal tolerable body weight support (BWS) and maximum tolerable walking speed)
arm group label: Lokomat training
intervention type: Device
intervention name: 100% guidance force
description: Patients will walk in the Lokomat with 100% GF for a minimum of 20 minutes (same amount of body weight support and walking speed as in the first session)
arm group label: Lokomat training
intervention type: Device
intervention name: 60% guidance force
description: Patients will walk in the Lokomat with 60% GF for a minimum of 20 minutes (same amount of body weight support and walking speed as in the first session)
arm group label: Lokomat training
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eric Kerckhofs, Prof. Ph.D
role: Study Chair
affiliation: Vrije Universiteit Brussel
last name: Eva Swinnen, Prof. Ph.D
role: Study Director
affiliation: Vrije Universiteit Brussel
last name: Nina Lefeber, Ph.D student
role: Principal Investigator
affiliation: Vrije Universiteit Brussel
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Vrije Universiteit Brussel
investigator full name: Nina Lefeber
investigator title: Doctoral Researcher
mesh term: Stroke