<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/NCT04423796</url>
  </required_header>
  <id_info>
    <org_study_id>ROBEM I</org_study_id>
    <nct_id>NCT04423796</nct_id>
  </id_info>
  <brief_title>Robotic Assisted Early Mobilization in Ventilated ICU Patients</brief_title>
  <acronym>ROBEM-I</acronym>
  <official_title>Robotic Assisted Early Mobilization in Ventilated ICU Patients: an Interventional Randomized, Controlled Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Reactive Robotics GmbH</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Charite University, Berlin, Germany</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>
      Feasibility trial investigating robotic assisted early mobilization vs. early mobilization in&#xD;
      critically ill patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 13, 2020</start_date>
  <completion_date type="Actual">September 12, 2022</completion_date>
  <primary_completion_date type="Actual">August 14, 2022</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>
    <intervention_model_description>Randomized, controlled, parallel-group, open label pilot trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of early mobilization</measure>
    <time_frame>Up to Day 5</time_frame>
    <description>Frequency of early mobilization performed by one health care provider during mechanical ventilation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mobilization level</measure>
    <time_frame>up to Day 5</time_frame>
    <description>Mobilization level during mechanical ventilation using the ICU Mobility Scale (IMS) ranging from 0-10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mobilization duration</measure>
    <time_frame>up to Day 5</time_frame>
    <description>Duration of mobilzation sessions during mechanical ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of mobilization</measure>
    <time_frame>up to Day 5</time_frame>
    <description>Frequency of early mobilization during mechanical ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain level</measure>
    <time_frame>up to Day 5</time_frame>
    <description>Pain level at mobilization using a numerical scale (NRS 0-10) or BPS 3-12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>up to Day 5</time_frame>
    <description>Anxiety due to mobilization using a numerical scale (NRS 0-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction with mobilization</measure>
    <time_frame>Up to Day 5</time_frame>
    <description>Satisfaction with mobilization using a numerical scale (NRS 0-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory response</measure>
    <time_frame>Up to Day 5</time_frame>
    <description>Zytokin change from before to after mobilization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health care provider assessment</measure>
    <time_frame>Up to Day 5</time_frame>
    <description>Assessment of the satisfaction with the mobilization by the health care provider using Likert-Scales (1-5)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle wasting</measure>
    <time_frame>Up to Day5</time_frame>
    <description>Muscle wasting will be assessed using ultrasound measurement of the M. femoris</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen consumption during mobilization</measure>
    <time_frame>Up to Day 5</time_frame>
    <description>Oxygen consupmtion during mobilization will be measured using calorimetrie during mobilization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oesophageal pressure</measure>
    <time_frame>Up to Day 5</time_frame>
    <description>Oesophageal pressure will be measured during mobilization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety events</measure>
    <time_frame>Up to Day 5</time_frame>
    <description>Frequency of safety events during mobilization</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Critical Illness Polyneuromyopathy</condition>
  <condition>Critical Illness</condition>
  <condition>Early Ambulation</condition>
  <condition>Rehabilitation</condition>
  <arm_group>
    <arm_group_label>Robotic assisted early mobilization</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Robotic assisted early mobilization started within 72 hours of ICU admission.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Early mobilization</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Early mobilization started within 72 hours of ICU admission without the use of a robotic assistance. Mobilization is done by personell.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Robotic-assisted early mobilization</intervention_name>
    <description>The early mobilization is done by robotic assistance devices.</description>
    <arm_group_label>Robotic assisted early mobilization</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Early mobilization</intervention_name>
    <description>Early mobilization by health care professionals without robotic assistance.</description>
    <arm_group_label>Early mobilization</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Invasive mechanically ventilated and expected to be ventilated for another 24 hours&#xD;
&#xD;
          -  Cardiovascular stability, allowing mobilization&#xD;
&#xD;
          -  Respiratory stability, allowing mobilization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bed-bound before ICU admission&#xD;
&#xD;
          -  Bed-rest order or contraindication of weight load of the lower extremity or spine&#xD;
&#xD;
          -  Severe skin lesions or fasciitis in the area of contact with the device or&#xD;
             rhabdomyolysis&#xD;
&#xD;
          -  Fresh SAB, ICB or elevated ICP&#xD;
&#xD;
          -  Status epilepticus&#xD;
&#xD;
          -  Acute intoxication&#xD;
&#xD;
          -  Shock with catecholamine doses &gt;0.3µg/kg/min or acute bleeding including organ&#xD;
             ruptures&#xD;
&#xD;
          -  Multiorgan failure with lactate &gt; 4 mmol/l&#xD;
&#xD;
          -  Body height outside the range 150-195 cm&#xD;
&#xD;
          -  Body weight outside the range 45-135 kg&#xD;
&#xD;
          -  pAVK IV°&#xD;
&#xD;
          -  Pacemakers or other electrical stimulators&#xD;
&#xD;
          -  Implanted medical pumps&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Life expectancy below 7 days or acute palliative care situation&#xD;
&#xD;
          -  Death inevitable or maximum therapy is not carried out by the treating physicians or&#xD;
             due to patient's request&#xD;
&#xD;
          -  Unable to understand the official language&#xD;
&#xD;
          -  ICU stay &gt; 72h at the time of enrolment&#xD;
&#xD;
        Translated with www.DeepL.com/Translator (free version)&#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>Stefan J Schaller, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Charite University, Berlin, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Charité - Univiversitätsmedizin Berlin</name>
      <address>
        <city>Berlin-Mitte</city>
        <state>Berlin</state>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>June 6, 2020</study_first_submitted>
  <study_first_submitted_qc>June 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>September 7, 2023</last_update_submitted>
  <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Stefan J Schaller</investigator_full_name>
    <investigator_title>Deputy Clinical Director</investigator_title>
  </responsible_party>
  <keyword>Early mobilization</keyword>
  <keyword>pilot trial</keyword>
  <keyword>feasibility trial</keyword>
  <keyword>robotic assisted</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Anonymized data can be requested from the PI after publication of the study for scientific purpose.</ipd_description>
    <ipd_time_frame>After publishing results.</ipd_time_frame>
    <ipd_access_criteria>Data will be shared to other researchers on reasonable request.</ipd_access_criteria>
  </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/NCT04423796
org study id: ROBEM I
nct id: NCT04423796
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Feasibility trial investigating robotic assisted early mobilization vs. early mobilization in
      critically ill patients.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, controlled, parallel-group, open label pilot trial
primary purpose: Treatment
masking: None (Open Label)
measure: Feasibility of early mobilization
time frame: Up to Day 5
description: Frequency of early mobilization performed by one health care provider during mechanical ventilation
measure: Mobilization level
time frame: up to Day 5
description: Mobilization level during mechanical ventilation using the ICU Mobility Scale (IMS) ranging from 0-10
measure: Mobilization duration
time frame: up to Day 5
description: Duration of mobilzation sessions during mechanical ventilation
measure: Frequency of mobilization
time frame: up to Day 5
description: Frequency of early mobilization during mechanical ventilation
measure: Pain level
time frame: up to Day 5
description: Pain level at mobilization using a numerical scale (NRS 0-10) or BPS 3-12
measure: Anxiety
time frame: up to Day 5
description: Anxiety due to mobilization using a numerical scale (NRS 0-10)
measure: Patient satisfaction with mobilization
time frame: Up to Day 5
description: Satisfaction with mobilization using a numerical scale (NRS 0-10)
measure: Inflammatory response
time frame: Up to Day 5
description: Zytokin change from before to after mobilization
measure: Health care provider assessment
time frame: Up to Day 5
description: Assessment of the satisfaction with the mobilization by the health care provider using Likert-Scales (1-5)
measure: Muscle wasting
time frame: Up to Day5
description: Muscle wasting will be assessed using ultrasound measurement of the M. femoris
measure: Oxygen consumption during mobilization
time frame: Up to Day 5
description: Oxygen consupmtion during mobilization will be measured using calorimetrie during mobilization
measure: Oesophageal pressure
time frame: Up to Day 5
description: Oesophageal pressure will be measured during mobilization
measure: Safety events
time frame: Up to Day 5
description: Frequency of safety events during mobilization
arm group label: Robotic assisted early mobilization
arm group type: Experimental
description: Robotic assisted early mobilization started within 72 hours of ICU admission.
arm group label: Early mobilization
arm group type: Active Comparator
description: Early mobilization started within 72 hours of ICU admission without the use of a robotic assistance. Mobilization is done by personell.
intervention type: Device
intervention name: Robotic-assisted early mobilization
description: The early mobilization is done by robotic assistance devices.
arm group label: Robotic assisted early mobilization
intervention type: Other
intervention name: Early mobilization
description: Early mobilization by health care professionals without robotic assistance.
arm group label: Early mobilization
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stefan J Schaller, MD
role: Principal Investigator
affiliation: Charite University, Berlin, Germany
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Stefan J Schaller
investigator title: Deputy Clinical Director
mesh term: Critical Illness
sharing ipd: Yes
ipd description: Anonymized data can be requested from the PI after publication of the study for scientific purpose.
ipd time frame: After publishing results.
ipd access criteria: Data will be shared to other researchers on reasonable request.