<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/NCT03755076</url>
  </required_header>
  <id_info>
    <org_study_id>1 R01 HD095992-01A1</org_study_id>
    <nct_id>NCT03755076</nct_id>
  </id_info>
  <brief_title>Perceptual-motor Interaction to Improve Bimanual Coordination After Stroke</brief_title>
  <acronym>Bimanual</acronym>
  <official_title>Perceptual-motor Interaction to Improve Bimanual Coordination After Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Albert Einstein Healthcare Network</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Albert Einstein Healthcare Network</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>
      Significant difficulty in incorporating the weaker arm in daily activities after stroke is,&#xD;
      in part, driven by difficulty in engaging both arms interactively in a coordinated manner.&#xD;
&#xD;
      The current study aims to determine the nature of bimanual coordination deficits after stroke&#xD;
      and takes initial steps to test a novel theory-driven approach to improve interactive&#xD;
      bimanual coordination in patients with stroke. This project will advance stroke&#xD;
      rehabilitation by identifying novel, scientifically-based strategies to improve the&#xD;
      engagement of the weaker arm in coordinated and interactive bimanual actions of daily life,&#xD;
      thus improving quality of life in individuals after stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Overall materials and methods: The proposed experiments will follow the general pattern we&#xD;
      have used in previous behavioral psychophysical studies in individuals with and without&#xD;
      stroke. A controlled virtual environment that records kinematics of the arm and allows&#xD;
      real-time movement interaction with a virtual motor task will be used. A program integrating&#xD;
      motion capture system (Acsention Technology TrakSTAR) and MATLAB-based GUI-gaming environment&#xD;
      allows tracking of the two arms, experimenter-control for specific manipulation such as&#xD;
      position of the virtual brick, target gap, relative contribution of the arms and mapping of&#xD;
      each arm movement to the movement of the virtual brick to provide real-time and post-response&#xD;
      feedback. Participants will be seated in an adjustable chair facing a computer monitor with&#xD;
      their trunk constrained to the chair. Their arms will be completely supported on a low&#xD;
      friction table top and free to move in the horizontal (X-Y) plane with minimal resistance. An&#xD;
      opaque screen will occlude participants' direct vision of their arms. Magnetic markers will&#xD;
      be secured to their hands just proximal to the wrist joint and the position of the markers&#xD;
      mapped to a virtual brick shown on the computer screen. The motor task is to move the virtual&#xD;
      brick(s) to a virtual target gap(s) on the computer screen by moving both arms in 2D (X-Y)&#xD;
      plane on the low-friction table. While real-time visual feedback of the brick is available,&#xD;
      the brick cannot be felt haptically. From a perceptual perspective, in independent goal&#xD;
      condition, each arm moves its own virtual brick to the target gap. In common-goal condition,&#xD;
      a common brick was moved on the computer screen to a target window by predetermined weighting&#xD;
      of each arm movement.&#xD;
&#xD;
      Prior to beginning the experiments, participants will reach with the paretic arm in three&#xD;
      different directions (135º, 90º and 45º relative to the horizontal) to record the maximum&#xD;
      reaching distance for two trials in each direction. The minimum reach distance across the&#xD;
      three directions will be used to calibrate the start and end position of the target gaps. The&#xD;
      target window position will be placed at 70 and 90% of the maximum reach distance, oriented&#xD;
      at 45º, 90º and 135º relative to the horizontal. From a motor execution perspective, bimanual&#xD;
      reaching to the 90º target will require mirror movements of the two arms in a forward&#xD;
      direction. Reaching to 45º and 135º targets will require parallel movements of the two arms&#xD;
      in those directions. Mirror and parallel movements have been shown to require distinct motor&#xD;
      control strategies, as well as different levels of transcallosal inhibition, hence have been&#xD;
      included in this study.&#xD;
&#xD;
      Procedures: Participants will come to the laboratory for a baseline evaluation to determine&#xD;
      eligibility to participate in the experimental protocol. During this baseline evaluation, we&#xD;
      will perform the following tests: (1) Fugl-Meyer Examination, (2) Mini-mental scale, (3)&#xD;
      Tests for hemineglect using a line-bisection test, (4) Western Aphasia Battery for patients&#xD;
      with Aphasia (5) TMS safety questionnaire, (6) MRI safety questionnaire, (7) Box and Block&#xD;
      test as well as (8) Penn Neurocognitive assessment.&#xD;
&#xD;
      Once the patients qualify for the study, they will come to the lab for three separate&#xD;
      sessions. The first two sessions will be behavioral sessions while the third session will be&#xD;
      a neuroimaging session.&#xD;
&#xD;
      During the first behavioral session, participants will be tested for bimanual coordination in&#xD;
      two different tasks- virtual-reality (VR) based task and real-world tasks. In the VR-based&#xD;
      task, we will test a total of 240 trials under different conditions to obtain a baseline&#xD;
      performance data. We will also have participants perform a battery of bimanual real-world&#xD;
      tasks. During the second session, we will test the effect of two different perceptual cues on&#xD;
      bimanual coordination. During Aim 2 experiments, participants will be instructed to &quot;move&quot; a&#xD;
      common virtual brick with both arms to the target windows in three directions (mirror- 90º;&#xD;
      parallel- 45º and135º) without tilting the brick within a target MT of 800 milliseconds- 1.2&#xD;
      seconds. Participants will complete four 60-trial blocks a pseudorandom order. Each block&#xD;
      will consist of a distinct task conditiondepending upon the nature of perceptual cues&#xD;
      provided.&#xD;
&#xD;
      Condition 1 will be similar to the common-goal bimanual condition in Aim 1 where they will&#xD;
      transport a common virtual block fixed in a horizontal position to three targets in&#xD;
      pseudorandom order. The movement of the bar will be an unweighted average of the two arm&#xD;
      movements; i.e., each arm will contribute to 50% of the virtual bar movement (50-50&#xD;
      weighting). For Condition 2, the weighting coefficients of the two arms will be equal (i.e.&#xD;
      50-50); and the virtual brick will tilt in the direction of the lagging arm proportional to&#xD;
      the relative time-lag between arms.Operational definition of relative time-lag: Relative&#xD;
      time-lag is different than absolute time lag. Relative time-lagis the time-lag between the&#xD;
      relative timing of each arm within its trajectory. To illustrate, if the left and right arm&#xD;
      are contributing to 70 and 30% of the brick movement, relative time-lag at mid-movement will&#xD;
      be zero if the left and right arm have covered half of their respective trajectories.&#xD;
      Therefore, relative time-lag is influenced by temporal as well as spatial component of the&#xD;
      movement of each arm. Concurrent and post-response feedback about the tilt and path of the&#xD;
      virtual brick will be provided after each trial.&#xD;
&#xD;
      Condition 3 will be similar to block 1 (block fixed in horizontal position), but the arm&#xD;
      weighting will be 70-30. Condition 4: In addition to the &quot;tilt&quot; feedback about the relative&#xD;
      time-lag, each arm will be differentially weighted- i.e., the paretic arm will have a higher&#xD;
      weighting coefficient compared to the nonparetic arm. Specifically, the paretic arm will&#xD;
      contribute to 70% of the virtual brick movement while the nonparetic arm will contribute to&#xD;
      30% of the virtual brick movement. 20 trials of bimanual reaching in each direction (90º; 45º&#xD;
      and 135º) will be completed in pseudorandom order.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">April 19, 2019</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>
    <intervention_model_description>Participants will perform bilateral arm movements in a virtual reality environment under different perceptual conditions to identify a condition that improves coordination between arms.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time-lag between hands in seconds</measure>
    <time_frame>One hour after training</time_frame>
    <description>Time-lag is a measure of temporal coordination</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Spatial coordination measured as cross-correlation coefficient</measure>
    <time_frame>One hour after training</time_frame>
    <description>Cross-correlation is how spatially aligned the two hands are.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Perceptual cuing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two perceptual cues will be provided: (a) feedback about the time-lag between the two arms presented as a horizontal tilt of the common goal, and (b) different movement weighting coefficients to each arm to force greater movement contribution of the paretic arm in a bimanual context. The effect of the two cues on bimanual coordination will be determined.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Perceptual cuing</intervention_name>
    <description>The two perceptual cues are: (a) feedback about the time-lag between the two arms presented as a horizontal tilt of the common goal, and (b) different movement weighting coefficients to each arm to force greater movement contribution of the paretic arm in a bimanual context.</description>
    <arm_group_label>Perceptual cuing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Clinical diagnosis of unilateral stroke&#xD;
&#xD;
          2. ability to reach along a diagonal direction at least 80% of their arm length while&#xD;
             fully supported on a frictionless surface and trunk constrained.&#xD;
&#xD;
          3. Mini-mental scale score &gt; 26, OR s score of 4 or above on auditory verbal&#xD;
             comprehension part of the Western Aphasia Battery to ensure intact comprehension and&#xD;
             following commands.&#xD;
&#xD;
        (e) no evidence of hemispatial neglect tested by a line bisection test.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. bilateral stroke,&#xD;
&#xD;
          2. complete paralyses,&#xD;
&#xD;
          3. basal ganglia/cerebellar stroke,&#xD;
&#xD;
          4. pain or stiffness in upper extremity that will interfere with the task or inability to&#xD;
             follow task instructions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shailesh S Kantak, PhD, PT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Moss Rehabilitation Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Moss Rehabilitation Research Institute</name>
      <address>
        <city>Elkins Park</city>
        <state>Pennsylvania</state>
        <zip>19027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>October 25, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>July 25, 2022</last_update_submitted>
  <last_update_submitted_qc>July 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Albert Einstein Healthcare Network</investigator_affiliation>
    <investigator_full_name>Shailesh Kantak</investigator_full_name>
    <investigator_title>Institute Scientist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03755076
org study id: 1 R01 HD095992-01A1
nct id: NCT03755076
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Significant difficulty in incorporating the weaker arm in daily activities after stroke is,
      in part, driven by difficulty in engaging both arms interactively in a coordinated manner.

      The current study aims to determine the nature of bimanual coordination deficits after stroke
      and takes initial steps to test a novel theory-driven approach to improve interactive
      bimanual coordination in patients with stroke. This project will advance stroke
      rehabilitation by identifying novel, scientifically-based strategies to improve the
      engagement of the weaker arm in coordinated and interactive bimanual actions of daily life,
      thus improving quality of life in individuals after stroke.
Overall materials and methods: The proposed experiments will follow the general pattern we
      have used in previous behavioral psychophysical studies in individuals with and without
      stroke. A controlled virtual environment that records kinematics of the arm and allows
      real-time movement interaction with a virtual motor task will be used. A program integrating
      motion capture system (Acsention Technology TrakSTAR) and MATLAB-based GUI-gaming environment
      allows tracking of the two arms, experimenter-control for specific manipulation such as
      position of the virtual brick, target gap, relative contribution of the arms and mapping of
      each arm movement to the movement of the virtual brick to provide real-time and post-response
      feedback. Participants will be seated in an adjustable chair facing a computer monitor with
      their trunk constrained to the chair. Their arms will be completely supported on a low
      friction table top and free to move in the horizontal (X-Y) plane with minimal resistance. An
      opaque screen will occlude participants' direct vision of their arms. Magnetic markers will
      be secured to their hands just proximal to the wrist joint and the position of the markers
      mapped to a virtual brick shown on the computer screen. The motor task is to move the virtual
      brick(s) to a virtual target gap(s) on the computer screen by moving both arms in 2D (X-Y)
      plane on the low-friction table. While real-time visual feedback of the brick is available,
      the brick cannot be felt haptically. From a perceptual perspective, in independent goal
      condition, each arm moves its own virtual brick to the target gap. In common-goal condition,
      a common brick was moved on the computer screen to a target window by predetermined weighting
      of each arm movement.

      Prior to beginning the experiments, participants will reach with the paretic arm in three
      different directions (135º, 90º and 45º relative to the horizontal) to record the maximum
      reaching distance for two trials in each direction. The minimum reach distance across the
      three directions will be used to calibrate the start and end position of the target gaps. The
      target window position will be placed at 70 and 90% of the maximum reach distance, oriented
      at 45º, 90º and 135º relative to the horizontal. From a motor execution perspective, bimanual
      reaching to the 90º target will require mirror movements of the two arms in a forward
      direction. Reaching to 45º and 135º targets will require parallel movements of the two arms
      in those directions. Mirror and parallel movements have been shown to require distinct motor
      control strategies, as well as different levels of transcallosal inhibition, hence have been
      included in this study.

      Procedures: Participants will come to the laboratory for a baseline evaluation to determine
      eligibility to participate in the experimental protocol. During this baseline evaluation, we
      will perform the following tests: (1) Fugl-Meyer Examination, (2) Mini-mental scale, (3)
      Tests for hemineglect using a line-bisection test, (4) Western Aphasia Battery for patients
      with Aphasia (5) TMS safety questionnaire, (6) MRI safety questionnaire, (7) Box and Block
      test as well as (8) Penn Neurocognitive assessment.

      Once the patients qualify for the study, they will come to the lab for three separate
      sessions. The first two sessions will be behavioral sessions while the third session will be
      a neuroimaging session.

      During the first behavioral session, participants will be tested for bimanual coordination in
      two different tasks- virtual-reality (VR) based task and real-world tasks. In the VR-based
      task, we will test a total of 240 trials under different conditions to obtain a baseline
      performance data. We will also have participants perform a battery of bimanual real-world
      tasks. During the second session, we will test the effect of two different perceptual cues on
      bimanual coordination. During Aim 2 experiments, participants will be instructed to "move" a
      common virtual brick with both arms to the target windows in three directions (mirror- 90º;
      parallel- 45º and135º) without tilting the brick within a target MT of 800 milliseconds- 1.2
      seconds. Participants will complete four 60-trial blocks a pseudorandom order. Each block
      will consist of a distinct task conditiondepending upon the nature of perceptual cues
      provided.

      Condition 1 will be similar to the common-goal bimanual condition in Aim 1 where they will
      transport a common virtual block fixed in a horizontal position to three targets in
      pseudorandom order. The movement of the bar will be an unweighted average of the two arm
      movements; i.e., each arm will contribute to 50% of the virtual bar movement (50-50
      weighting). For Condition 2, the weighting coefficients of the two arms will be equal (i.e.
      50-50); and the virtual brick will tilt in the direction of the lagging arm proportional to
      the relative time-lag between arms.Operational definition of relative time-lag: Relative
      time-lag is different than absolute time lag. Relative time-lagis the time-lag between the
      relative timing of each arm within its trajectory. To illustrate, if the left and right arm
      are contributing to 70 and 30% of the brick movement, relative time-lag at mid-movement will
      be zero if the left and right arm have covered half of their respective trajectories.
      Therefore, relative time-lag is influenced by temporal as well as spatial component of the
      movement of each arm. Concurrent and post-response feedback about the tilt and path of the
      virtual brick will be provided after each trial.

      Condition 3 will be similar to block 1 (block fixed in horizontal position), but the arm
      weighting will be 70-30. Condition 4: In addition to the "tilt" feedback about the relative
      time-lag, each arm will be differentially weighted- i.e., the paretic arm will have a higher
      weighting coefficient compared to the nonparetic arm. Specifically, the paretic arm will
      contribute to 70% of the virtual brick movement while the nonparetic arm will contribute to
      30% of the virtual brick movement. 20 trials of bimanual reaching in each direction (90º; 45º
      and 135º) will be completed in pseudorandom order.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Participants will perform bilateral arm movements in a virtual reality environment under different perceptual conditions to identify a condition that improves coordination between arms.
primary purpose: Basic Science
masking: None (Open Label)
measure: Time-lag between hands in seconds
time frame: One hour after training
description: Time-lag is a measure of temporal coordination
measure: Spatial coordination measured as cross-correlation coefficient
time frame: One hour after training
description: Cross-correlation is how spatially aligned the two hands are.
arm group label: Perceptual cuing
arm group type: Experimental
description: Two perceptual cues will be provided: (a) feedback about the time-lag between the two arms presented as a horizontal tilt of the common goal, and (b) different movement weighting coefficients to each arm to force greater movement contribution of the paretic arm in a bimanual context. The effect of the two cues on bimanual coordination will be determined.
intervention type: Behavioral
intervention name: Perceptual cuing
description: The two perceptual cues are: (a) feedback about the time-lag between the two arms presented as a horizontal tilt of the common goal, and (b) different movement weighting coefficients to each arm to force greater movement contribution of the paretic arm in a bimanual context.
arm group label: Perceptual cuing
criteria: 
gender: All
minimum age: 21 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Shailesh S Kantak, PhD, PT
role: Principal Investigator
affiliation: Moss Rehabilitation Research Institute
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Albert Einstein Healthcare Network
investigator full name: Shailesh Kantak
investigator title: Institute Scientist
mesh term: Stroke
sharing ipd: No