<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/NCT03285919</url>
  </required_header>
  <id_info>
    <org_study_id>URIS201703</org_study_id>
    <nct_id>NCT03285919</nct_id>
  </id_info>
  <brief_title>Perturbed-balance Training During Treadmill Walking for Stroke Subjects</brief_title>
  <acronym>BALANCESI</acronym>
  <official_title>Feasibility of Perturbed-balance Training During Treadmill Walking in a High-functioning Chronic Stroke Subject: a Case-control Study</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>
      A control and a post-stroke subject with right-side chronic hemiparesis were studied. The&#xD;
      post-stroke subject underwent 30 sessions of balance-perturbed training while walking on an&#xD;
      instrumented treadmill where the Balance Assessment Robot (BAR™) randomly delivered pushes to&#xD;
      pelvis in various directions at various speeds and at various perturbation amplitudes. The&#xD;
      investigators assessed kinematics, kinetics, electromiography and spatio-temporal responses&#xD;
      to outward-directed perturbations commencing either at foot contact of the left or the right&#xD;
      leg.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For a detailed description of the study, see the Arms and Interventions section.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 5, 2016</start_date>
  <completion_date type="Actual">June 2, 2017</completion_date>
  <primary_completion_date type="Actual">June 2, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-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 centre of mass of the Case</measure>
    <time_frame>Assessment at session no. 3 (during week 1) and session no. 30 (during week 10)</time_frame>
    <description>For the purpose of qualitative assessment of kinematics and kinetics</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in centre of pressure of the Case</measure>
    <time_frame>Assessment at session no. 3 (during week 1) and session no. 30 (during week 10)</time_frame>
    <description>For the purpose of qualitative assessment of kinematics and kinetics</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in ground reaction force of the Case</measure>
    <time_frame>Assessment at session no. 3 (during week 1) and session no. 30 (during week 10)</time_frame>
    <description>For the purpose of qualitative assessment of kinematics and kinetics</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Centre of mass of the Control</measure>
    <time_frame>During the only session (i.e., session 1 on day 1)</time_frame>
    <description>For the purpose of qualitative assessment of spatio-temporal characteristics of stepping</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Centre of pressure of the Control</measure>
    <time_frame>During the only session (i.e., session 1 on day 1)</time_frame>
    <description>For the purpose of qualitative assessment of spatio-temporal characteristics of stepping</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ground reaction force of the Control</measure>
    <time_frame>During the only session (i.e., session 1 on day 1)</time_frame>
    <description>For the purpose of qualitative assessment of spatio-temporal characteristics of stepping</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Step length</measure>
    <time_frame>During both assessment sessions for the Case (i.e., session no. 3 during week 1, and session no. 30 during week 10); during the only session (i.e., session 1 on day 1) for the Control</time_frame>
    <description>For the purpose of qualitative assessment of spatio-temporal characteristics of stepping</description>
  </other_outcome>
  <other_outcome>
    <measure>Step width</measure>
    <time_frame>During both assessment sessions for the Case (i.e., session no. 3 during week 1, and session no. 30 during week 10); during the only session (i.e., session 1 on day 1) for the Control</time_frame>
    <description>For the purpose of qualitative assessment of spatio-temporal characteristics of stepping</description>
  </other_outcome>
  <other_outcome>
    <measure>Step time</measure>
    <time_frame>During both assessment sessions for the Case (i.e., session no. 3 during week 1, and session no. 30 during week 10); during the only session (i.e., session 1 on day 1) for the Control</time_frame>
    <description>For the purpose of qualitative assessment of spatio-temporal characteristics of stepping</description>
  </other_outcome>
  <other_outcome>
    <measure>Electromiography (at M. tibialis anterior, M. soleus, M. gastrocnemius lat., M. gastrocnemius med., M. rectus femoris, M. semitendinosus, M. gluteus med., M. gluteus max.)</measure>
    <time_frame>During both assessment sessions for the Case (i.e., session no. 3 during week 1, and session no. 30 during week 10); during the only session (i.e., session 1 on day 1) for the Control</time_frame>
    <description>For the purpose of qualitative assessment</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Case - stroke survivor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stroke survivor, 6mon post stroke resulting in right-sided hemiparesis, 53yrs old, had completed a 2mon rehabilitation program prior to the study. He underwent 30 training sessions with the Balance Assessment Robot (BAR™) within a 10-week period, each consisting of 10-15min of unperturbed treadmill and 30-45min of perturbation training. Perturbations were delivered in the forward, backward, left and right direction, occurring every 6sec, at the left leg initial contact and the right leg initial contact. Two training sessions were spent to determine adequate treadmill speed (0.4m/s) and perturbation amplitude (60N), followed by the first assessment session. After the last training session, assessment was repeated using the same parameters plus 90N perturbation amplitude.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control - matched healthy subject</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Healthy male, height- and weight-matched to the Case. He was assessed according to the same protocol as the Case using the Balance Assessment Robot (BAR™) at perturbation amplitudes 60 and 90 N.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Balance Assessment Robot (BAR™)</intervention_name>
    <description>The BAR™ has got six degrees of freedom (DOF) that interface to the pelvis of a walking subject. Five DOFs (translation of pelvis in sagittal, lateral and vertical directions; pelvic rotation and pelvic list) are actuated and admittance-controlled, providing transparent haptic interaction with negligible power transfer; the remaining DOF (pelvic tilt) is passive. The BAR™ is capable of delivering perturbations in the directions forward/backward and left/right, but for the purpose of this study only &quot;outward&quot; perturbations in the frontal plane were considered.</description>
    <arm_group_label>Case - stroke survivor</arm_group_label>
    <arm_group_label>Control - matched healthy subject</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Case: community-dwelling, high-functioning stroke survivor&#xD;
&#xD;
          -  Control: healthy volunteer, height- and weight-matched to the Case&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  any disease or injury affecting cognition&#xD;
&#xD;
          -  any disease or injury affecting balance or gait&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zlatko Matjačić, 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>
  <reference>
    <citation>Olensek A, Zadravec M, Matjacic Z. A novel robot for imposing perturbations during overground walking: mechanism, control and normative stepping responses. J Neuroeng Rehabil. 2016 Jun 11;13(1):55. doi: 10.1186/s12984-016-0160-7.</citation>
    <PMID>27287551</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>September 15, 2017</last_update_submitted>
  <last_update_submitted_qc>September 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>perturbed walking</keyword>
  <keyword>stepping response</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03285919
org study id: URIS201703
nct id: NCT03285919
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A control and a post-stroke subject with right-side chronic hemiparesis were studied. The
      post-stroke subject underwent 30 sessions of balance-perturbed training while walking on an
      instrumented treadmill where the Balance Assessment Robot (BAR™) randomly delivered pushes to
      pelvis in various directions at various speeds and at various perturbation amplitudes. The
      investigators assessed kinematics, kinetics, electromiography and spatio-temporal responses
      to outward-directed perturbations commencing either at foot contact of the left or the right
      leg.
For a detailed description of the study, see the Arms and Interventions section.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Change in centre of mass of the Case
time frame: Assessment at session no. 3 (during week 1) and session no. 30 (during week 10)
description: For the purpose of qualitative assessment of kinematics and kinetics
measure: Change in centre of pressure of the Case
time frame: Assessment at session no. 3 (during week 1) and session no. 30 (during week 10)
description: For the purpose of qualitative assessment of kinematics and kinetics
measure: Change in ground reaction force of the Case
time frame: Assessment at session no. 3 (during week 1) and session no. 30 (during week 10)
description: For the purpose of qualitative assessment of kinematics and kinetics
measure: Centre of mass of the Control
time frame: During the only session (i.e., session 1 on day 1)
description: For the purpose of qualitative assessment of spatio-temporal characteristics of stepping
measure: Centre of pressure of the Control
time frame: During the only session (i.e., session 1 on day 1)
description: For the purpose of qualitative assessment of spatio-temporal characteristics of stepping
measure: Ground reaction force of the Control
time frame: During the only session (i.e., session 1 on day 1)
description: For the purpose of qualitative assessment of spatio-temporal characteristics of stepping
measure: Step length
time frame: During both assessment sessions for the Case (i.e., session no. 3 during week 1, and session no. 30 during week 10); during the only session (i.e., session 1 on day 1) for the Control
description: For the purpose of qualitative assessment of spatio-temporal characteristics of stepping
measure: Step width
time frame: During both assessment sessions for the Case (i.e., session no. 3 during week 1, and session no. 30 during week 10); during the only session (i.e., session 1 on day 1) for the Control
description: For the purpose of qualitative assessment of spatio-temporal characteristics of stepping
measure: Step time
time frame: During both assessment sessions for the Case (i.e., session no. 3 during week 1, and session no. 30 during week 10); during the only session (i.e., session 1 on day 1) for the Control
description: For the purpose of qualitative assessment of spatio-temporal characteristics of stepping
measure: Electromiography (at M. tibialis anterior, M. soleus, M. gastrocnemius lat., M. gastrocnemius med., M. rectus femoris, M. semitendinosus, M. gluteus med., M. gluteus max.)
time frame: During both assessment sessions for the Case (i.e., session no. 3 during week 1, and session no. 30 during week 10); during the only session (i.e., session 1 on day 1) for the Control
description: For the purpose of qualitative assessment
arm group label: Case - stroke survivor
arm group type: Experimental
description: Stroke survivor, 6mon post stroke resulting in right-sided hemiparesis, 53yrs old, had completed a 2mon rehabilitation program prior to the study. He underwent 30 training sessions with the Balance Assessment Robot (BAR™) within a 10-week period, each consisting of 10-15min of unperturbed treadmill and 30-45min of perturbation training. Perturbations were delivered in the forward, backward, left and right direction, occurring every 6sec, at the left leg initial contact and the right leg initial contact. Two training sessions were spent to determine adequate treadmill speed (0.4m/s) and perturbation amplitude (60N), followed by the first assessment session. After the last training session, assessment was repeated using the same parameters plus 90N perturbation amplitude.
arm group label: Control - matched healthy subject
arm group type: Active Comparator
description: Healthy male, height- and weight-matched to the Case. He was assessed according to the same protocol as the Case using the Balance Assessment Robot (BAR™) at perturbation amplitudes 60 and 90 N.
intervention type: Device
intervention name: Balance Assessment Robot (BAR™)
description: The BAR™ has got six degrees of freedom (DOF) that interface to the pelvis of a walking subject. Five DOFs (translation of pelvis in sagittal, lateral and vertical directions; pelvic rotation and pelvic list) are actuated and admittance-controlled, providing transparent haptic interaction with negligible power transfer; the remaining DOF (pelvic tilt) is passive. The BAR™ is capable of delivering perturbations in the directions forward/backward and left/right, but for the purpose of this study only "outward" perturbations in the frontal plane were considered.
arm group label: Case - stroke survivor
arm group label: Control - matched healthy subject
criteria: 
gender: Male
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Zlatko Matjačić, PhD
role: Principal Investigator
affiliation: University Rehabilitation Institute, Republic of Slovenia
facility: 
country: Slovenia
citation: Olensek A, Zadravec M, Matjacic Z. A novel robot for imposing perturbations during overground walking: mechanism, control and normative stepping responses. J Neuroeng Rehabil. 2016 Jun 11;13(1):55. doi: 10.1186/s12984-016-0160-7.
PMID: 27287551
responsible party type: Sponsor
mesh term: Stroke
sharing ipd: Undecided