xml: <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/NCT05962697</url>
    </required_header>
    <id_info>
      <org_study_id>A4631-P</org_study_id>
      <secondary_id>RZ004631</secondary_id>
      <nct_id>NCT05962697</nct_id>
    </id_info>
    <brief_title>An Upper Extremity Exoskeleton to Target Unwanted Joint Synergies During Repetitive Training in Stroke Survivors</brief_title>
    <official_title>Developing and Determining Feasibility of a Novel Upper Extremity Robotic Exoskeleton to Track and Target Unwanted Joint Synergies During Repetitive Task Training in Stroke Survivors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>VA Office of Research and Development</agency>
        <agency_class>U.S. Fed</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>VA Office of Research and Development</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Stroke is the leading cause of adult-onset disability, and affects 15,000 Veterans each year.&#xD;
        Successful rehabilitation and recovery following a stroke requires therapy including&#xD;
        repetitive task training. However, repetitive task training can be draining for both the&#xD;
        clinician and the patient as it requires the participant to complete many repetitions of the&#xD;
        same task and those repetitions can be difficult to accomplish with appropriate technique.&#xD;
        Robot-mediated repetitive task training has the potential to facilitate the clinical delivery&#xD;
        of proven rehabilitation programs to Veterans in need and recently a new exoskeleton has been&#xD;
        developed, called Harmony, which can deliver bimanual 3D arm therapy. The investigators&#xD;
        propose to develop and test two novel controllers', synergy avoidance and task assistance,&#xD;
        that use promising neurological basis for training to facilitate repetitive task training&#xD;
        while ensuring correct movement patterns in acute and sub-acute stage stroke patients. This&#xD;
        has the potential to improve Veterans' activities of daily living and quality of life.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Stroke causes significant long-term disability and the incidence of stroke in Veteran&#xD;
        population is high with approximately 6,000 VA admissions for acute ischemic stroke per year&#xD;
        in 2014. Rehabilitation programs that improve upper extremity function have the potential to&#xD;
        impact Veterans' activities of daily living and improve their vocation, recreation, and&#xD;
        overall quality of life. Repetitive task training (RTT) is active practice of a task-specific&#xD;
        motor activity and is more effective than simple joint movements in improving upper extremity&#xD;
        function after treatment. However, RTT can be draining for both the clinician and the patient&#xD;
        as it requires the participant to complete many repetitions of the same task and those&#xD;
        repetitions can be difficult to accomplish with appropriate technique. Previous research has&#xD;
        shown that to significantly affect patient recovery it is critical to initiate RTT in the&#xD;
        acute and sub-acute stages, maintain health joint coordination, and keep the patients engaged&#xD;
        and challenged. Robot-mediated RTT has the potential to facilitate the clinical delivery of&#xD;
        proven rehabilitation programs to Veterans in need and recently a new exoskeleton has been&#xD;
        developed, called Harmony, with the ability to deliver bimanual 3D arm therapy. Currently&#xD;
        there a lack of tools for delivering RTT in the early stages of recovery while maintaining&#xD;
        joint coordination during 3D arm movement and ensuring that assistance commensurate with&#xD;
        patient abilities. Therefore, the objective of this project is to develop novel controllers&#xD;
        that use promising neurological basis for training to facilitate repetitive task training&#xD;
        while ensuring correct movement patterns in acute and sub-acute stage stroke patients.&#xD;
        Specifically, (1) synergy avoidance (SA) controller will apply joint torques to push the&#xD;
        patients away from the maladaptive joint coordination, only interfering with the movements&#xD;
        once the subject initiates such a maladaptive movement strategy. (2) Task assistance (TA)&#xD;
        controller will apply assistive joint torques to directly help stroke patients achieve 3D RTT&#xD;
        activities with correct coordination at a high intensity (repetitions/session). Aim 1: to&#xD;
        develop and determine feasibility of RTT controller. H1: SA and TA controllers are feasible,&#xD;
        as seen by (1) patient safety and (2) abilities of TA and SA controllers to move upper-body&#xD;
        joints along task trajectories and away from synergistic coordination, respectively. Up to&#xD;
        five sub-acute stroke survivors will complete RTT activities with both the SA and TA&#xD;
        controllers. H1 will be considered supported if the applied torque meets the requirements&#xD;
        defined by the control law and the feasibility criteria are met for the TA and SA controllers&#xD;
        in two consecutive patients. Aim 2: determine feasibility of controllers and quantify change&#xD;
        in joint coordination during 3-week intervention. H2a: a 3-week long intervention is feasible&#xD;
        with both the controllers as seen by (1) patient safety and (2) abilities for TA and SA&#xD;
        controllers to move the upper-body joints toward the desired trajectories for 3D RTT&#xD;
        activities while avoiding synergistic compensatory coordination. H2b: the robotic system will&#xD;
        accurately track joint synergies in acute stroke patients before and after a 3-week&#xD;
        intervention, revealing any change in compensatory strategies. Two acute stroke survivors&#xD;
        will be recruited. Participants will be assigned to either the TA or SA controller and will&#xD;
        complete high repetitions of reaching tasks once per day while wearing the Harmony&#xD;
        exoskeleton for three weeks. Joint kinematic and kinetic data will be recorded by the robotic&#xD;
        system in all the sessions. Kinematic data will also be recorded in the evaluation sessions&#xD;
        before and after the 3-week intervention in two modalities: robot in zero-torque mode and&#xD;
        using an infrared motion tracking system. Joint synergies will be evaluated for the two acute&#xD;
        stroke patients before and after a three-week intervention. Hypotheses will be considered&#xD;
        supported if there is an acceptably low rate of error between the kinematic measurements of&#xD;
        the robotic system and the motion capture system. New rehabilitation programs that improve&#xD;
        upper extremity functional performance have the potential to impact Veterans' ADL and improve&#xD;
        their vocation, recreation, and overall quality of life. New rehabilitation programs that&#xD;
        improve upper extremity function have the potential to impact Veterans' ADLs and improve&#xD;
        their vocation, recreation, and overall quality of life.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">April 1, 2024</start_date>
    <completion_date type="Anticipated">September 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 1, 2025</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change from Baseline Fugl-Meyer Upper Extremity (FM-UE) at 3 weeks</measure>
      <time_frame>3 weeks</time_frame>
      <description>Clinical measure of upper extremity function Range 0 to 66 - 0 is impaired, 66 is unimpaired</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from Baseline Action Research Arm Test (ARAT) at 3 weeks</measure>
      <time_frame>3 weeks</time_frame>
      <description>Clinical measure of upper extremity function Range 0 to 57 0 is impaired, 57 is unimpaired</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">7</enrollment>
    <condition>Acute Stroke</condition>
    <arm_group>
      <arm_group_label>SA controller</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Synergy assistance controller</description>
    </arm_group>
    <arm_group>
      <arm_group_label>early testing</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>up to 5 participants testing the SA controller in one visit</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>SA controller</intervention_name>
      <description>Novel controller to be tested</description>
      <arm_group_label>SA controller</arm_group_label>
      <other_name>Synergy assistance</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>TA controller</intervention_name>
      <description>original controller to be tested</description>
      <arm_group_label>SA controller</arm_group_label>
      <other_name>Task assistance</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>SA controller early testing</intervention_name>
      <description>Novel controller to be tested early testing</description>
      <arm_group_label>early testing</arm_group_label>
      <other_name>Synergy assistance early testing</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  over the age of 18 years,&#xD;
  &#xD;
            -  have a Fugl-Meyer Upper Extremity score of 29-42 for moderately impaired (aim 1) or&#xD;
               0-28 for severely impaired (aim 1 and 2),&#xD;
  &#xD;
            -  have body dimensions within the limits of the Harmony system&#xD;
  &#xD;
            -  suffered a stroke within the past 1-6 months (aim 1) or 1 week (aim 2)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  recurrent stroke,&#xD;
  &#xD;
            -  unstable cardiovascular, orthopedic, or neurological conditions,&#xD;
  &#xD;
            -  a history of seizure,&#xD;
  &#xD;
            -  significant communication deficits,&#xD;
  &#xD;
            -  severe upper-limb joint pain or limitations that would restrict their ability to&#xD;
               complete the protocols,&#xD;
  &#xD;
            -  inadequate cognitive or language function to consent or to participate, and (7) no&#xD;
               phone number or stable mailing address.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Brittney C Muir, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>VA Puget Sound Health Care System Seattle Division, Seattle, WA</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Brittney C Muir, PhD</last_name>
      <phone>(206) 277-3261</phone>
      <email>brittney.muir@va.gov</email>
    </overall_contact>
    <location>
      <facility>
        <name>VA Puget Sound Health Care System Seattle Division, Seattle, WA</name>
        <address>
          <city>Seattle</city>
          <state>Washington</state>
          <zip>98108-1532</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Brittney C Muir, PhD</last_name>
        <phone>206-277-3261</phone>
        <email>brittney.muir@va.gov</email>
      </contact>
      <investigator>
        <last_name>Brittney C Muir, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 10, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Stroke</keyword>
    <keyword>Exoskeleton</keyword>
    <keyword>upper extremity</keyword>
    <keyword>robot</keyword>
    <keyword>rehabilitation</keyword>
    <keyword>joint synergy</keyword>
    <keyword>controller</keyword>
    <keyword>feasibility</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>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05962697
  org study id: A4631-P
  secondary id: RZ004631
  nct id: NCT05962697
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Stroke is the leading cause of adult-onset disability, and affects 15,000 Veterans each year.
        Successful rehabilitation and recovery following a stroke requires therapy including
        repetitive task training. However, repetitive task training can be draining for both the
        clinician and the patient as it requires the participant to complete many repetitions of the
        same task and those repetitions can be difficult to accomplish with appropriate technique.
        Robot-mediated repetitive task training has the potential to facilitate the clinical delivery
        of proven rehabilitation programs to Veterans in need and recently a new exoskeleton has been
        developed, called Harmony, which can deliver bimanual 3D arm therapy. The investigators
        propose to develop and test two novel controllers', synergy avoidance and task assistance,
        that use promising neurological basis for training to facilitate repetitive task training
        while ensuring correct movement patterns in acute and sub-acute stage stroke patients. This
        has the potential to improve Veterans' activities of daily living and quality of life.
  Stroke causes significant long-term disability and the incidence of stroke in Veteran
        population is high with approximately 6,000 VA admissions for acute ischemic stroke per year
        in 2014. Rehabilitation programs that improve upper extremity function have the potential to
        impact Veterans' activities of daily living and improve their vocation, recreation, and
        overall quality of life. Repetitive task training (RTT) is active practice of a task-specific
        motor activity and is more effective than simple joint movements in improving upper extremity
        function after treatment. However, RTT can be draining for both the clinician and the patient
        as it requires the participant to complete many repetitions of the same task and those
        repetitions can be difficult to accomplish with appropriate technique. Previous research has
        shown that to significantly affect patient recovery it is critical to initiate RTT in the
        acute and sub-acute stages, maintain health joint coordination, and keep the patients engaged
        and challenged. Robot-mediated RTT has the potential to facilitate the clinical delivery of
        proven rehabilitation programs to Veterans in need and recently a new exoskeleton has been
        developed, called Harmony, with the ability to deliver bimanual 3D arm therapy. Currently
        there a lack of tools for delivering RTT in the early stages of recovery while maintaining
        joint coordination during 3D arm movement and ensuring that assistance commensurate with
        patient abilities. Therefore, the objective of this project is to develop novel controllers
        that use promising neurological basis for training to facilitate repetitive task training
        while ensuring correct movement patterns in acute and sub-acute stage stroke patients.
        Specifically, (1) synergy avoidance (SA) controller will apply joint torques to push the
        patients away from the maladaptive joint coordination, only interfering with the movements
        once the subject initiates such a maladaptive movement strategy. (2) Task assistance (TA)
        controller will apply assistive joint torques to directly help stroke patients achieve 3D RTT
        activities with correct coordination at a high intensity (repetitions/session). Aim 1: to
        develop and determine feasibility of RTT controller. H1: SA and TA controllers are feasible,
        as seen by (1) patient safety and (2) abilities of TA and SA controllers to move upper-body
        joints along task trajectories and away from synergistic coordination, respectively. Up to
        five sub-acute stroke survivors will complete RTT activities with both the SA and TA
        controllers. H1 will be considered supported if the applied torque meets the requirements
        defined by the control law and the feasibility criteria are met for the TA and SA controllers
        in two consecutive patients. Aim 2: determine feasibility of controllers and quantify change
        in joint coordination during 3-week intervention. H2a: a 3-week long intervention is feasible
        with both the controllers as seen by (1) patient safety and (2) abilities for TA and SA
        controllers to move the upper-body joints toward the desired trajectories for 3D RTT
        activities while avoiding synergistic compensatory coordination. H2b: the robotic system will
        accurately track joint synergies in acute stroke patients before and after a 3-week
        intervention, revealing any change in compensatory strategies. Two acute stroke survivors
        will be recruited. Participants will be assigned to either the TA or SA controller and will
        complete high repetitions of reaching tasks once per day while wearing the Harmony
        exoskeleton for three weeks. Joint kinematic and kinetic data will be recorded by the robotic
        system in all the sessions. Kinematic data will also be recorded in the evaluation sessions
        before and after the 3-week intervention in two modalities: robot in zero-torque mode and
        using an infrared motion tracking system. Joint synergies will be evaluated for the two acute
        stroke patients before and after a three-week intervention. Hypotheses will be considered
        supported if there is an acceptably low rate of error between the kinematic measurements of
        the robotic system and the motion capture system. New rehabilitation programs that improve
        upper extremity functional performance have the potential to impact Veterans' ADL and improve
        their vocation, recreation, and overall quality of life. New rehabilitation programs that
        improve upper extremity function have the potential to impact Veterans' ADLs and improve
        their vocation, recreation, and overall quality of life.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change from Baseline Fugl-Meyer Upper Extremity (FM-UE) at 3 weeks
  time frame: 3 weeks
  description: Clinical measure of upper extremity function Range 0 to 66 - 0 is impaired, 66 is unimpaired
  measure: Change from Baseline Action Research Arm Test (ARAT) at 3 weeks
  time frame: 3 weeks
  description: Clinical measure of upper extremity function Range 0 to 57 0 is impaired, 57 is unimpaired
  arm group label: SA controller
  arm group type: Experimental
  description: Synergy assistance controller
  arm group label: early testing
  arm group type: Other
  description: up to 5 participants testing the SA controller in one visit
  intervention type: Other
  intervention name: SA controller
  description: Novel controller to be tested
  arm group label: SA controller
  other name: Synergy assistance
  intervention type: Other
  intervention name: TA controller
  description: original controller to be tested
  arm group label: SA controller
  other name: Task assistance
  intervention type: Other
  intervention name: SA controller early testing
  description: Novel controller to be tested early testing
  arm group label: early testing
  other name: Synergy assistance early testing
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Brittney C Muir, PhD
  role: Principal Investigator
  affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
  last name: Brittney C Muir, PhD
  phone: (206) 277-3261
  email: brittney.muir@va.gov
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Stroke
  sharing ipd: No