<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/NCT04452019</url>
  </required_header>
  <id_info>
    <org_study_id>REK106287</org_study_id>
    <nct_id>NCT04452019</nct_id>
  </id_info>
  <brief_title>Use of Standing Frame and &quot;Innowalk Pro&quot; in Patients With TBI</brief_title>
  <official_title>Responses on Use of Standing Frame and &quot;Innowalk Pro&quot; in Subacute Patients With Severe Functional Deficits Due to Acquired Brain Injury.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sunnaas Rehabilitation Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Made for Movement</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sunnaas Rehabilitation Hospital</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>
      This study will explore physical and physiological responses to mobilization of patients with&#xD;
      acquired brain injuries in subacute phase using a classic standing frame and a standing&#xD;
      device with simultaneous passive movement of legs, &quot;Innowalk Pro&quot;.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Several studies underline the importance of early mobilization of patients with brain&#xD;
      injuries, leading to shorter hospital stays, less contractures, and improved general&#xD;
      function.&#xD;
&#xD;
      The routine mobilization treatment in the rehabilitation of patients with severe brain&#xD;
      injuries in Sunnaas Rehabilitation Hospital is initial use of a tilt table where tilt angle&#xD;
      is gradually increased, and when tolerated, standing in a classic standing frame where the&#xD;
      patient's lower body is fixed to the device in an upright standing position.&#xD;
&#xD;
      &quot;Innowalk Pro&quot; is a robotic standing device where legs are fixed, but passively moved by&#xD;
      electric motors in an upright standing position. An assumption is that standing in &quot;Innowalk&#xD;
      Pro&quot; might be better tolerated at an earlier stage of rehabilitation than standing in a&#xD;
      classic standing frame.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 19, 2020</start_date>
  <completion_date type="Actual">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">December 31, 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>Single Group Assignment</intervention_model>
    <intervention_model_description>All together each included patient will attend five sessions. First session includes an orthostatic test and other baseline measurements. In order to describe test-to-test variation (reliability) when using the devices, two sessions are held in standard standing frame (A) and two sessions in &quot;Innowalk Pro&quot; (B), preferably within the same week. If, for practical reasons, this is not feasible, training is allowed in the following week. The order of the workouts is block randomized to ABAB or BABA at inclusion. The orthostic test and the training session are estimated to last approx. 1 hour including all measurements.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Standing time in minutes</measure>
    <time_frame>Up to one week</time_frame>
    <description>Tolerated maximal standing time in each standing device.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>Up to one week</time_frame>
    <description>Blood pressure is monitored continuously</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>up to one week</time_frame>
    <description>Heart rate will be monitored continuously 5 minutes before and during intervention with Polar 5000</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle activity in legs</measure>
    <time_frame>up to one week</time_frame>
    <description>Any muscle activity in legs during standing session will be monitored by EMG using &quot;Musclelab&quot; (from &quot;Ergotest Innovations&quot;) on vastus medialis, hamstrings, tibialis ant. and gastrocnemius muscles.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spasticity</measure>
    <time_frame>up to one week</time_frame>
    <description>Spasticity in knee flexors and ankle flexors will be measured by Modified Ashworth scale (0-4 where 0= no increase in tone and 4 = rigid limb)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived exertion</measure>
    <time_frame>up to one week</time_frame>
    <description>For patients who are cognitive capable, perceived exertion will be registrated on Borg Scale of perceived exertion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients reporting pain</measure>
    <time_frame>up to one week</time_frame>
    <description>Negative impact during training</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of skin issues</measure>
    <time_frame>up to one week</time_frame>
    <description>The number of patients reporting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of near faints will be registered by the staff.</measure>
    <time_frame>up to one week</time_frame>
    <description>Negative impact during training</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Brain Injuries</condition>
  <arm_group>
    <arm_group_label>Standing frame</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Use of standard standing frame</description>
  </arm_group>
  <arm_group>
    <arm_group_label>&quot;Innowalk Pro&quot;</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of a new device; &quot;Innowalk Pro&quot;</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Use of standard standing frame</intervention_name>
    <description>Two training sessions in a standard standing frame, max 30 min. pr. session</description>
    <arm_group_label>&quot;Innowalk Pro&quot;</arm_group_label>
    <arm_group_label>Standing frame</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Use of a new device; Innowalk Pro</intervention_name>
    <description>Two training sessions in Innowalk Pro, max 30 min pr. session</description>
    <arm_group_label>&quot;Innowalk Pro&quot;</arm_group_label>
    <arm_group_label>Standing frame</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Severe brain injury / stroke &lt;1 year post injury.&#xD;
&#xD;
          -  Medically stable&#xD;
&#xD;
          -  Paresis in lower extremities, minimal walking function (even with personal assistance)&#xD;
             (FIM movement (walk), score 1-2)&#xD;
&#xD;
          -  Planned stay in Sunnaas RH for a minimum of 2 weeks from time of inclusion&#xD;
&#xD;
          -  Tolerate 5 minutes in 40 degrees 'upright' position in tilt table (custom orthostasis&#xD;
             test)&#xD;
&#xD;
          -  Body weight ≤95 kg&#xD;
&#xD;
          -  Body height ≤190 cm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Fractures in the lower extremities or in the columna with movement or strain&#xD;
             restrictions or with pain.&#xD;
&#xD;
          -  Aggressive and provocative behavior that affects the ability to collaborate.&#xD;
&#xD;
          -  Other conditions where upright position is contraindicated&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vivien Jørgensen, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sunnaas Rehabilitaion Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sunnaas Rehabilitation Hospital</name>
      <address>
        <city>Nesoddtangen</city>
        <zip>1450</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <link>
    <url>http://bora.uib.no/handle/1956/11981</url>
    <description>WESCHE, A.P 2015 Master thesis in Norwegian. &quot;Tidlig mobilisering av voksne pasienter med ervervet hjerneskade ved bruk av &quot;Innowalk Pro&quot;.</description>
  </link>
  <link>
    <url>https://www.madeformovement.com/innowalk-pro</url>
    <description>&quot;Innowalk Pro&quot;</description>
  </link>
  <reference>
    <citation>Glickman LB, Geigle PR, Paleg GS. A systematic review of supported standing programs. J Pediatr Rehabil Med. 2010;3(3):197-213. doi: 10.3233/PRM-2010-0129.</citation>
    <PMID>21791851</PMID>
  </reference>
  <reference>
    <citation>Riberholt CG, Lindschou J, Gluud C, Mehlsen J, Moller K. Early mobilisation by head-up tilt with stepping versus standard care after severe traumatic brain injury - Protocol for a randomised clinical feasibility trial. Trials. 2018 Nov 8;19(1):612. doi: 10.1186/s13063-018-3004-x.</citation>
    <PMID>30409170</PMID>
  </reference>
  <reference>
    <citation>Riberholt CG, Thorlund JB, Mehlsen J, Nordenbo AM. Patients with severe acquired brain injury show increased arousal in tilt-table training. Dan Med J. 2013 Dec;60(12):A4739.</citation>
    <PMID>24355448</PMID>
  </reference>
  <reference>
    <citation>Frazzitta G, Zivi I, Valsecchi R, Bonini S, Maffia S, Molatore K, Sebastianelli L, Zarucchi A, Matteri D, Ercoli G, Maestri R, Saltuari L. Effectiveness of a Very Early Stepping Verticalization Protocol in Severe Acquired Brain Injured Patients: A Randomized Pilot Study in ICU. PLoS One. 2016 Jul 22;11(7):e0158030. doi: 10.1371/journal.pone.0158030. eCollection 2016.</citation>
    <PMID>27447483</PMID>
  </reference>
  <reference>
    <citation>Piene Wesche A, Strand LI, Jorgensen V, Opheim A, Hoyer E. Early mobilization of a patient with acquired brain injury using a new standing aid, the Innowalk Pro. A single subject experimental design. Disabil Rehabil Assist Technol. 2023 May;18(4):407-414. doi: 10.1080/17483107.2020.1860143. Epub 2020 Dec 23.</citation>
    <PMID>33355016</PMID>
  </reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>April 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>April 13, 2023</last_update_submitted>
  <last_update_submitted_qc>April 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>standing</keyword>
  <keyword>blood pressure</keyword>
  <keyword>heart rate</keyword>
  <keyword>surface electromyography of muscles in legs</keyword>
  <keyword>perceived exertion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Anonymous IPD will be available on request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Data will be available when study has been competed.</ipd_time_frame>
    <ipd_access_criteria>Requests will be reviewed by the Project group.</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/NCT04452019
org study id: REK106287
nct id: NCT04452019
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will explore physical and physiological responses to mobilization of patients with
      acquired brain injuries in subacute phase using a classic standing frame and a standing
      device with simultaneous passive movement of legs, "Innowalk Pro".
Several studies underline the importance of early mobilization of patients with brain
      injuries, leading to shorter hospital stays, less contractures, and improved general
      function.

      The routine mobilization treatment in the rehabilitation of patients with severe brain
      injuries in Sunnaas Rehabilitation Hospital is initial use of a tilt table where tilt angle
      is gradually increased, and when tolerated, standing in a classic standing frame where the
      patient's lower body is fixed to the device in an upright standing position.

      "Innowalk Pro" is a robotic standing device where legs are fixed, but passively moved by
      electric motors in an upright standing position. An assumption is that standing in "Innowalk
      Pro" might be better tolerated at an earlier stage of rehabilitation than standing in a
      classic standing frame.
allocation: Randomized
intervention model: Single Group Assignment
intervention model description: All together each included patient will attend five sessions. First session includes an orthostatic test and other baseline measurements. In order to describe test-to-test variation (reliability) when using the devices, two sessions are held in standard standing frame (A) and two sessions in "Innowalk Pro" (B), preferably within the same week. If, for practical reasons, this is not feasible, training is allowed in the following week. The order of the workouts is block randomized to ABAB or BABA at inclusion. The orthostic test and the training session are estimated to last approx. 1 hour including all measurements.
primary purpose: Treatment
masking: None (Open Label)
measure: Standing time in minutes
time frame: Up to one week
description: Tolerated maximal standing time in each standing device.
measure: Blood pressure
time frame: Up to one week
description: Blood pressure is monitored continuously
measure: Heart rate
time frame: up to one week
description: Heart rate will be monitored continuously 5 minutes before and during intervention with Polar 5000
measure: Muscle activity in legs
time frame: up to one week
description: Any muscle activity in legs during standing session will be monitored by EMG using "Musclelab" (from "Ergotest Innovations") on vastus medialis, hamstrings, tibialis ant. and gastrocnemius muscles.
measure: Spasticity
time frame: up to one week
description: Spasticity in knee flexors and ankle flexors will be measured by Modified Ashworth scale (0-4 where 0= no increase in tone and 4 = rigid limb)
measure: Perceived exertion
time frame: up to one week
description: For patients who are cognitive capable, perceived exertion will be registrated on Borg Scale of perceived exertion
measure: Number of patients reporting pain
time frame: up to one week
description: Negative impact during training
measure: Rate of skin issues
time frame: up to one week
description: The number of patients reporting
measure: Number of near faints will be registered by the staff.
time frame: up to one week
description: Negative impact during training
arm group label: Standing frame
arm group type: Active Comparator
description: Use of standard standing frame
arm group label: "Innowalk Pro"
arm group type: Experimental
description: Use of a new device; "Innowalk Pro"
intervention type: Device
intervention name: Use of standard standing frame
description: Two training sessions in a standard standing frame, max 30 min. pr. session
arm group label: "Innowalk Pro"
arm group label: Standing frame
intervention type: Device
intervention name: Use of a new device; Innowalk Pro
description: Two training sessions in Innowalk Pro, max 30 min pr. session
arm group label: "Innowalk Pro"
arm group label: Standing frame
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Vivien Jørgensen, Phd
role: Principal Investigator
affiliation: Sunnaas Rehabilitaion Hospital
facility: 
country: Norway
url: http://bora.uib.no/handle/1956/11981
description: WESCHE, A.P 2015 Master thesis in Norwegian. "Tidlig mobilisering av voksne pasienter med ervervet hjerneskade ved bruk av "Innowalk Pro".
url: https://www.madeformovement.com/innowalk-pro
description: "Innowalk Pro"
citation: Glickman LB, Geigle PR, Paleg GS. A systematic review of supported standing programs. J Pediatr Rehabil Med. 2010;3(3):197-213. doi: 10.3233/PRM-2010-0129.
PMID: 21791851
citation: Riberholt CG, Lindschou J, Gluud C, Mehlsen J, Moller K. Early mobilisation by head-up tilt with stepping versus standard care after severe traumatic brain injury - Protocol for a randomised clinical feasibility trial. Trials. 2018 Nov 8;19(1):612. doi: 10.1186/s13063-018-3004-x.
PMID: 30409170
citation: Riberholt CG, Thorlund JB, Mehlsen J, Nordenbo AM. Patients with severe acquired brain injury show increased arousal in tilt-table training. Dan Med J. 2013 Dec;60(12):A4739.
PMID: 24355448
citation: Frazzitta G, Zivi I, Valsecchi R, Bonini S, Maffia S, Molatore K, Sebastianelli L, Zarucchi A, Matteri D, Ercoli G, Maestri R, Saltuari L. Effectiveness of a Very Early Stepping Verticalization Protocol in Severe Acquired Brain Injured Patients: A Randomized Pilot Study in ICU. PLoS One. 2016 Jul 22;11(7):e0158030. doi: 10.1371/journal.pone.0158030. eCollection 2016.
PMID: 27447483
citation: Piene Wesche A, Strand LI, Jorgensen V, Opheim A, Hoyer E. Early mobilization of a patient with acquired brain injury using a new standing aid, the Innowalk Pro. A single subject experimental design. Disabil Rehabil Assist Technol. 2023 May;18(4):407-414. doi: 10.1080/17483107.2020.1860143. Epub 2020 Dec 23.
PMID: 33355016
responsible party type: Sponsor
mesh term: Brain Injuries
sharing ipd: Yes
ipd description: Anonymous IPD will be available on request.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: Data will be available when study has been competed.
ipd access criteria: Requests will be reviewed by the Project group.