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/NCT05996198</url>
    </required_header>
    <id_info>
      <org_study_id>23-00842</org_study_id>
      <nct_id>NCT05996198</nct_id>
    </id_info>
    <brief_title>Exoskeletal Support in Stroke</brief_title>
    <official_title>A Pilot Proof of Concept, Single Site Study to Assess the Effect of Exoskeletal Support on Motor Control Strategies in Individuals With Stroke</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>NYU Langone Health</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>NYU Langone Health</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This interventional study will measure motor performance, including 3D movement analysis and&#xD;
        muscle activity, in response to exoskeleton assistance. The cohort design will compare stroke&#xD;
        patients to healthy controls. Data collection will be conducted in a single, 2-hour session.&#xD;
        Investigators will also access stroke patients' brain MRIs that were obtained as standard of&#xD;
        care during acute admission for stroke.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 21, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Relative Contribution (RC) Level</measure>
      <time_frame>Baseline, End of VR Task (Day 1 - session lasts approx. 2 hours)</time_frame>
      <description>Measured via arm trajectory analysis as a percentage (%); evaluates arm control.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Muscle Contribution (MC) Level</measure>
      <time_frame>Baseline, End of VR Task (Day 1 - session lasts approx. 2 hours)</time_frame>
      <description>Measured via electromyographical analysis as a percentage (%); evaluates arm control.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Corticospinal Tract (CST) Lesion Load</measure>
      <time_frame>Baseline</time_frame>
      <description>Measured via MRI; lesion load is expressed as percentage of the entire CST.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Stroke</condition>
    <arm_group>
      <arm_group_label>Patients with History of Stroke</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Individuals with history of stroke more than 6 months prior to enrollment.&#xD;
  Participants will complete 3 blocks of 54 trials in a single session. Block 1 is a baseline phase where subjects will perform reaches without any loads applied via the exoskeleton devices. Block 2 is the intervention block where bilateral exoskeletons apply gravity assistance to the impaired arm for stroke survivors and gravity resistance to the non-impaired arm. Block 3 is a retention block, where tested procedures are identical to block 1.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthy Controls</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Healthy age and gender-matched control participants.&#xD;
  Participants will complete 3 blocks of 54 trials in a single session. Block 1 is a baseline phase where subjects will perform reaches without any loads applied via the exoskeleton devices. Block 2 is the intervention block where bilateral exoskeletons apply gravity assistance to the non-dominant arm and resistance is applied to the dominant arm in healthy controls. Block 3 is a retention block, where tested procedures are identical to block 1.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Oculus Rift headset</intervention_name>
      <description>The Oculus Rift is a commercially-available virtual reality (VR) headset. It is used to present the visual environment in which participants perform the reaching task.</description>
      <arm_group_label>Healthy Controls</arm_group_label>
      <arm_group_label>Patients with History of Stroke</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Exoskeleton Device</intervention_name>
      <description>The exoskeleton was designed and constructed to provide either gravity assistance or gravity resistance. It applies a torque to both shoulders. Torque values do not exceed 50% of the torque due to gravity. The device is mounted to a testing chair and attached to the participant using Velcro straps.</description>
      <arm_group_label>Healthy Controls</arm_group_label>
      <arm_group_label>Patients with History of Stroke</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Healthy controls:&#xD;
  &#xD;
            -  Having obtained the age of 18 years&#xD;
  &#xD;
            -  Neurologically healthy (i.e., no history of: traumatic brain injury, peripheral&#xD;
               neuropathy, seizures, etc.)&#xD;
  &#xD;
            -  Strongly right-handed according to at least 80% score on the Edinburgh Handedness&#xD;
               Inventory (Oldfield, 1971; Veale, 2013). The use of right-handed participants is a&#xD;
               common feature in this field of study. This is due to the slight differences in arm&#xD;
               control between left- and right-handed individuals (Sainburg &amp; Kalakanis, 2000).&#xD;
  &#xD;
            -  Ability to give informed consent&#xD;
  &#xD;
          Survivors of stroke:&#xD;
  &#xD;
            -  Having obtained the age of 18 years&#xD;
  &#xD;
            -  have a diagnosis of stroke more than six months prior to entry into the study;&#xD;
  &#xD;
            -  have the ability to reach, unsupported, to approximately 70% of arm length&#xD;
  &#xD;
            -  ability to give informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          All participants&#xD;
  &#xD;
            -  have any conditions that limit their capability of using a Head Mounted Display (HMD)&#xD;
               for a VR environment or cooperate with the protocol.&#xD;
  &#xD;
            -  have any orthopedic injuries to the upper extremities.&#xD;
  &#xD;
            -  Have neurological injuries other than stroke.&#xD;
  &#xD;
            -  Have excessive pain in any joint of either arm that could limit the ability to&#xD;
               cooperate with the protocols.&#xD;
  &#xD;
            -  Visuospatial neglect&#xD;
  &#xD;
            -  Apraxia&#xD;
  &#xD;
            -  Global inattention&#xD;
  &#xD;
            -  Legal blindness&#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>Heidi Schambra, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>NYU Langone Health</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Alexander Brunfeldt, PhD</last_name>
      <phone>929-455-5517</phone>
      <email>alexander.brunfeldt@nyulangone.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Heidi Schambra, MD</last_name>
      <phone>212-598-6000</phone>
      <email>Heidi.Schambra@nyulangone.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>NYU Langone Health (222 East 41st Street)</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10017</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </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>Yes</sharing_ipd>
      <ipd_description>The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Alexander Brunfeldt, PhD [alexander.brunfeldt@nyulangone.org]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.</ipd_time_frame>
      <ipd_access_criteria>The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Alexander Brunfeldt, PhD [alexander.brunfeldt@nyulangone.org]. To gain access, data requestors will need to sign a data access agreement.</ipd_access_criteria>
    </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/NCT05996198
  org study id: 23-00842
  nct id: NCT05996198
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: No
  This interventional study will measure motor performance, including 3D movement analysis and
        muscle activity, in response to exoskeleton assistance. The cohort design will compare stroke
        patients to healthy controls. Data collection will be conducted in a single, 2-hour session.
        Investigators will also access stroke patients' brain MRIs that were obtained as standard of
        care during acute admission for stroke.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in Relative Contribution (RC) Level
  time frame: Baseline, End of VR Task (Day 1 - session lasts approx. 2 hours)
  description: Measured via arm trajectory analysis as a percentage (%); evaluates arm control.
  measure: Change in Muscle Contribution (MC) Level
  time frame: Baseline, End of VR Task (Day 1 - session lasts approx. 2 hours)
  description: Measured via electromyographical analysis as a percentage (%); evaluates arm control.
  measure: Corticospinal Tract (CST) Lesion Load
  time frame: Baseline
  description: Measured via MRI; lesion load is expressed as percentage of the entire CST.
  arm group label: Patients with History of Stroke
  arm group type: Experimental
  description: Individuals with history of stroke more than 6 months prior to enrollment.
  Participants will complete 3 blocks of 54 trials in a single session. Block 1 is a baseline phase where subjects will perform reaches without any loads applied via the exoskeleton devices. Block 2 is the intervention block where bilateral exoskeletons apply gravity assistance to the impaired arm for stroke survivors and gravity resistance to the non-impaired arm. Block 3 is a retention block, where tested procedures are identical to block 1.
  arm group label: Healthy Controls
  arm group type: Experimental
  description: Healthy age and gender-matched control participants.
  Participants will complete 3 blocks of 54 trials in a single session. Block 1 is a baseline phase where subjects will perform reaches without any loads applied via the exoskeleton devices. Block 2 is the intervention block where bilateral exoskeletons apply gravity assistance to the non-dominant arm and resistance is applied to the dominant arm in healthy controls. Block 3 is a retention block, where tested procedures are identical to block 1.
  intervention type: Device
  intervention name: Oculus Rift headset
  description: The Oculus Rift is a commercially-available virtual reality (VR) headset. It is used to present the visual environment in which participants perform the reaching task.
  arm group label: Healthy Controls
  arm group label: Patients with History of Stroke
  intervention type: Device
  intervention name: Exoskeleton Device
  description: The exoskeleton was designed and constructed to provide either gravity assistance or gravity resistance. It applies a torque to both shoulders. Torque values do not exceed 50% of the torque due to gravity. The device is mounted to a testing chair and attached to the participant using Velcro straps.
  arm group label: Healthy Controls
  arm group label: Patients with History of Stroke
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Heidi Schambra, MD
  role: Principal Investigator
  affiliation: NYU Langone Health
  last name: Alexander Brunfeldt, PhD
  phone: 929-455-5517
  email: alexander.brunfeldt@nyulangone.org
  last name: Heidi Schambra, MD
  phone: 212-598-6000
  email: Heidi.Schambra@nyulangone.org
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Stroke
  sharing ipd: Yes
  ipd description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Alexander Brunfeldt, PhD [alexander.brunfeldt@nyulangone.org]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
  ipd access criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Alexander Brunfeldt, PhD [alexander.brunfeldt@nyulangone.org]. To gain access, data requestors will need to sign a data access agreement.