<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/NCT03782948</url>
  </required_header>
  <id_info>
    <org_study_id>URIS201802</org_study_id>
    <nct_id>NCT03782948</nct_id>
  </id_info>
  <brief_title>Effect of Robotised Gait Training on Dynamic Balance, Symmetry and Push-off in Persons After Stroke</brief_title>
  <acronym>BART</acronym>
  <official_title>Effect of Robotised Gait Training on Dynamic Balance, Symmetry and Push-off in Persons After Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Rehabilitation Institute, Republic of Slovenia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Rehabilitation Institute, Republic of Slovenia</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>
      Rehabilitation robotics is increasingly used because it enables the patients to practice a&#xD;
      wide array of movements. Dynamic balance training is essential for gait rehabilitation and&#xD;
      robotised devices enhance repeatability, objectivity and precision of such training combined&#xD;
      with monitoring and recording of kinematic and kinetic data. The aim of the study is to&#xD;
      explore the effect of robot-assisted gait training on dynamic balance, symmetry and take-off&#xD;
      in patients after stroke. The investigators will conduct a randomised intervention study&#xD;
      where one group will receive visual feedback on gait status and the other group will receive&#xD;
      kinetically-assisted training using a robotised device in addition to the visual feedback.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gait training will start 3 weeks after admission to inpatient rehabilitation. It will last&#xD;
      for 3 weeks, 5 times per week, 30 minutes per day. The first few sessions with the robotic&#xD;
      device will serve to familiarise the patient with the BART device and training conditions.&#xD;
      Further details are described in the Arms and Interventions section.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 31, 2019</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</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>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in postural stability during walking</measure>
    <time_frame>Assessment before and after the 3-week training programme</time_frame>
    <description>Assessed using the Functional Gait Assessment (FGA) scale. The scale scores range from 0 to 30, with higher scores indicating less impairment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in functional ambulation category</measure>
    <time_frame>Assessment before and after the 3-week training programme</time_frame>
    <description>Assessed using the Functional Ambulation Categories (FAC) scale. The FAC is a 6-point scale (0-5), with higher category indicating better walking ability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in functional independence</measure>
    <time_frame>Assessment before and after the 3-week training programme</time_frame>
    <description>Assessed using the Motor subscale of the Functional Independence Measure (FIM). FIM Motor subscale scores range from 13 to 91, with higher scores indicating better functional independence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fall-risk related mobility</measure>
    <time_frame>Assessment before and after the 3-week training programme</time_frame>
    <description>Assessed using the Timed Up and Go (TUG) test. Longer TUG times indicate worse mobility (and thus higher fall risk).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in ability to change directions while stepping</measure>
    <time_frame>Assessment before and after the 3-week training programme</time_frame>
    <description>Assessed using the Four Square Step Test (FSST). The FSST is timed, with longer times indicating worse ability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in walking speed over a short distance</measure>
    <time_frame>Assessment before and after the 3-week training programme</time_frame>
    <description>Assessed using the 10 Meter Walk Test (10MWT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in walking speed over a long distance</measure>
    <time_frame>Assessment before and after the 3-week training programme</time_frame>
    <description>Assessed using the 6 Minute Walk Test (6MWT)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Changes in kinesiological characteristics of gait</measure>
    <time_frame>Assessment before and after the 3-week training programme</time_frame>
    <description>Assessed using the BART device</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In each session, the group will undergo standard gait training on BART without pelvic perturbations, i.e.,&#xD;
walk a virtual track on the BART without pelvic perturbations (i.e., the pelvic brace of the BART device will be set to follow the patient's motion) for 10 minutes;&#xD;
practise gait symmetry and take-off using visual feedback without pelvic perturbations in two 10-minute sessions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In each session, the group will undergo robotised gait training with BART with pelvic perturbations, i.e.,&#xD;
walk a virtual track on the BART with pelvic perturbations during virtual uphill walk and virtual curved walk for 10 minutes;&#xD;
practise gait symmetry and take-off using visual feedback with pelvic perturbations for 10 minutes;&#xD;
practise dynamic gait balance using pelvic perturbations during treadmill walking for 10 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard gait training on BART without pelvic perturbations</intervention_name>
    <description>The Balance Assisted Robot on Treadmill (BART) enables various types of gait training on treadmill with visual feedback. It interfaces to the pelvis of the walking subject in an actuated and admittance-controlled manner, thus providing transparent haptic interaction with negligible power transfer.</description>
    <arm_group_label>Controls</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Robotised gait training with BART with pelvic perturbations</intervention_name>
    <description>In addition to the standard gait training, the BART will deliver perturbations in the forward/backward and left/right direction.</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subacute phase after first ischaemic or haemorrhagic stroke (less than 6 months after&#xD;
             stroke);&#xD;
&#xD;
          -  Limb hemiparesis;&#xD;
&#xD;
          -  Ability to walk independently (FAC 6) or with assistance (FAC 5) on flat and uneven&#xD;
             surfaces, stairs and slopes;&#xD;
&#xD;
          -  Adequate cardiovascular ability (NYHA 1).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Degenerative process or postoperative condition on lower-limb joints that would hinder&#xD;
             gait;&#xD;
&#xD;
          -  Associated neurological disease;&#xD;
&#xD;
          -  Decreased cognitive ability (KPSS &lt; 25).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matjaž Zadravec, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Rehabilitation Institute, Republic of Slovenia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Rehabilitation Institute, Republic of Slovenia</name>
      <address>
        <city>Ljubljana</city>
        <zip>1000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Slovenia</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>February 12, 2021</last_update_submitted>
  <last_update_submitted_qc>February 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>gait training</keyword>
  <keyword>dynamic balance</keyword>
  <keyword>gait symmetry</keyword>
  <keyword>rehabilitation robotics</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/NCT03782948
org study id: URIS201802
nct id: NCT03782948
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Rehabilitation robotics is increasingly used because it enables the patients to practice a
      wide array of movements. Dynamic balance training is essential for gait rehabilitation and
      robotised devices enhance repeatability, objectivity and precision of such training combined
      with monitoring and recording of kinematic and kinetic data. The aim of the study is to
      explore the effect of robot-assisted gait training on dynamic balance, symmetry and take-off
      in patients after stroke. The investigators will conduct a randomised intervention study
      where one group will receive visual feedback on gait status and the other group will receive
      kinetically-assisted training using a robotised device in addition to the visual feedback.
Gait training will start 3 weeks after admission to inpatient rehabilitation. It will last
      for 3 weeks, 5 times per week, 30 minutes per day. The first few sessions with the robotic
      device will serve to familiarise the patient with the BART device and training conditions.
      Further details are described in the Arms and Interventions section.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Change in postural stability during walking
time frame: Assessment before and after the 3-week training programme
description: Assessed using the Functional Gait Assessment (FGA) scale. The scale scores range from 0 to 30, with higher scores indicating less impairment.
measure: Change in functional ambulation category
time frame: Assessment before and after the 3-week training programme
description: Assessed using the Functional Ambulation Categories (FAC) scale. The FAC is a 6-point scale (0-5), with higher category indicating better walking ability.
measure: Change in functional independence
time frame: Assessment before and after the 3-week training programme
description: Assessed using the Motor subscale of the Functional Independence Measure (FIM). FIM Motor subscale scores range from 13 to 91, with higher scores indicating better functional independence.
measure: Change in fall-risk related mobility
time frame: Assessment before and after the 3-week training programme
description: Assessed using the Timed Up and Go (TUG) test. Longer TUG times indicate worse mobility (and thus higher fall risk).
measure: Change in ability to change directions while stepping
time frame: Assessment before and after the 3-week training programme
description: Assessed using the Four Square Step Test (FSST). The FSST is timed, with longer times indicating worse ability.
measure: Change in walking speed over a short distance
time frame: Assessment before and after the 3-week training programme
description: Assessed using the 10 Meter Walk Test (10MWT)
measure: Change in walking speed over a long distance
time frame: Assessment before and after the 3-week training programme
description: Assessed using the 6 Minute Walk Test (6MWT)
measure: Changes in kinesiological characteristics of gait
time frame: Assessment before and after the 3-week training programme
description: Assessed using the BART device
arm group label: Controls
arm group type: Active Comparator
description: In each session, the group will undergo standard gait training on BART without pelvic perturbations, i.e.,
walk a virtual track on the BART without pelvic perturbations (i.e., the pelvic brace of the BART device will be set to follow the patient's motion) for 10 minutes;
practise gait symmetry and take-off using visual feedback without pelvic perturbations in two 10-minute sessions.
arm group label: Experimental
arm group type: Experimental
description: In each session, the group will undergo robotised gait training with BART with pelvic perturbations, i.e.,
walk a virtual track on the BART with pelvic perturbations during virtual uphill walk and virtual curved walk for 10 minutes;
practise gait symmetry and take-off using visual feedback with pelvic perturbations for 10 minutes;
practise dynamic gait balance using pelvic perturbations during treadmill walking for 10 minutes.
intervention type: Device
intervention name: Standard gait training on BART without pelvic perturbations
description: The Balance Assisted Robot on Treadmill (BART) enables various types of gait training on treadmill with visual feedback. It interfaces to the pelvis of the walking subject in an actuated and admittance-controlled manner, thus providing transparent haptic interaction with negligible power transfer.
arm group label: Controls
intervention type: Device
intervention name: Robotised gait training with BART with pelvic perturbations
description: In addition to the standard gait training, the BART will deliver perturbations in the forward/backward and left/right direction.
arm group label: Experimental
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Matjaž Zadravec, PhD
role: Principal Investigator
affiliation: University Rehabilitation Institute, Republic of Slovenia
facility: 
country: Slovenia
responsible party type: Sponsor
mesh term: Stroke