<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/NCT04429945</url>
  </required_header>
  <id_info>
    <org_study_id>N3449-P</org_study_id>
    <secondary_id>I21RX003449</secondary_id>
    <nct_id>NCT04429945</nct_id>
  </id_info>
  <brief_title>Immersive VR in Stroke Pilot Study</brief_title>
  <official_title>Immersive Virtual Reality to Improve Outcomes in Patients With Stroke: A Pilot Study</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>
      Over 15,000 Veterans are treated by the VA for stroke each year. A stroke means that part of&#xD;
      the brain dies. Many people who have a stroke have difficulty with moving their arm, using&#xD;
      their hand, and they have pain. Virtual reality is a video-game based treatment that may help&#xD;
      people with stroke improve in these areas. Virtual reality involves using a computer and&#xD;
      goggles to make a person feel like they are in a different world with new sights and sounds,&#xD;
      relaxing on a beach where there is no pain, or playing the piano. In virtual reality, stroke&#xD;
      patients can practice movement in a safe and motivating environment. For example, a person&#xD;
      with stroke who has weakness in his/her arm can safely reach for plates in a virtual&#xD;
      cupboard. In a virtual environment, the plates can't break. This study will help&#xD;
      investigators to determine if people with strokes who are treated with virtual reality like&#xD;
      it, and if they have less pain and better movement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background. Over the last decade, Virtual Reality (VR) has emerged as a cutting-edge&#xD;
      technology in stroke rehabilitation. VR is defined as a type of user-computer interface that&#xD;
      implements real-time simulation of an activity or environment allowing user interaction via&#xD;
      multiple sensory modalities. VR interventions in a stroke population have been shown to be&#xD;
      equivalent to usual care therapies and to enhance motor recovery when utilized as an adjunct.&#xD;
      Significance/Impact/Innovation. This research will advance knowledge in rehabilitation&#xD;
      research by testing state-of-the-art immersive 3-dimensional VR technology with the&#xD;
      post-acute stroke Veteran population. The proposed project addresses: (1) the RR&amp;D goal of&#xD;
      maximizing functional recovery, (2) interest in non-pharmacological activity-based&#xD;
      interventions for pain, and (3) supports modernization of the Veterans' Health Administration&#xD;
      by incorporating technology-assisted rehabilitation.&#xD;
&#xD;
      Specific Aims. (1) Determine the feasibility and tolerability of using a therapeutic VR&#xD;
      platform in an inpatient comprehensive stroke rehabilitation program and (2) Estimate the&#xD;
      initial clinical efficacy, or effect size, associated with the VR platform using APPS for&#xD;
      distraction and upper extremity exercise for Veterans post-stroke.&#xD;
&#xD;
      Methodology. Prospective within-subject pre-post pilot and survey study designs will be used.&#xD;
      The target populations are (1) clinical staff who work on the Comprehensive Interdisciplinary&#xD;
      Inpatient Rehabilitation Program (CIIRP) at the James A. Haley Veterans' Hospital (JAHVH) in&#xD;
      Tampa (sample size N=10) and Veterans who are inpatients in the CIIRP (sample size N=10). The&#xD;
      VR intervention consists of wearing a head mounted display that plays APPs ranging from music&#xD;
      and nature views for pain distraction to more challenging strengthening and coordination&#xD;
      activities such as playing the piano virtually. The intervention will last four weeks. The&#xD;
      analytic approach will use descriptive statistics and qualitative methods. Aim 1 will&#xD;
      administer a survey with open and closed ended questions to clinicians to examine the&#xD;
      feasibility of successfully integrating a VR intervention into the flow of usual care.&#xD;
      Feasibility constructs include adaptability (can VR intervention be adapted to an inpatient&#xD;
      unit), patient need (do Veterans like and benefit from the intervention), and staff&#xD;
      comments/impressions. Responses for each construct will be entered into an excel spreadsheet,&#xD;
      one tab for each construct. Responses will then be grouped by similar content. Results will&#xD;
      be reported as themes and subthemes. Aim 1 will also track patient VR tolerability by&#xD;
      documenting and discussing patient complaints and adverse events. Tolerability data will be&#xD;
      extracted from meeting minutes and grouped by similar occurrences. Results will be reported&#xD;
      as themes and subthemes. Aim 2 will estimate effect sizes and degree of precision for upper&#xD;
      extremity neurologic recovery, hand dexterity, and pain outcomes measured pre and post VR&#xD;
      intervention. Neurologic recovery is measured with the Fugl-Meyer Assessment of Motor&#xD;
      Recovery after Stroke-Upper Extremity, dexterity is measured with the Action Research Arm&#xD;
      Test, and pain is measured with the Pain Outcomes Questionnaire-VA. Because standard scores&#xD;
      do not necessarily translate to meaningful clinical differences (improvements), the&#xD;
      investigators will identify the proportion of subjects who experience the minimal clinically&#xD;
      important difference (MCID). Metrics will also be compared across outcomes.&#xD;
&#xD;
      Next Steps/Implementation. Our next step is to work with our Program Partner in the Physical&#xD;
      Medicine and Rehabilitation Office to conduct a large multi-site clinical trial that will&#xD;
      incorporate the lessons learned from this feasibility pilot study to test the efficacy of a&#xD;
      VR intervention in inpatient rehabilitation and transition to home evironments.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 14, 2021</start_date>
  <completion_date type="Actual">December 14, 2022</completion_date>
  <primary_completion_date type="Actual">December 14, 2022</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>Once patients are enrolled, baseline data and pre-intervention outcome measures will be collected. APPs will be selected from the VR Toolkit that best address the individual patient's treatment goals.&#xD;
Patients will be instructed in the use of the head mounted display with VR APPs. VR dosage will be two one-half hour sessions per therapy day. Patients can initiate use of a more challenging APPs that gradually includes hand/arm movement.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Action Research Arm Test</measure>
    <time_frame>4 weeks</time_frame>
    <description>measures recovery of arm and hand function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fugl-Meyer Assessment Upper Extremity</measure>
    <time_frame>4 weeks</time_frame>
    <description>measures problems with sensation and movement</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Outcomes Questionnaire-VA:Intake</measure>
    <time_frame>baseline, pre-intervention</time_frame>
    <description>level of pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Outcomes Questionnnaire-VA: Discharge</measure>
    <time_frame>4 weeks</time_frame>
    <description>level of pain</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Immersive Virtual Reality</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A Virtual Reality headset will be used for 30 minutes twice per day outside of usual therapy times while in bed with bedrails raised. Virtual Reality games will be selected that will help with relaxation, pain, and arm and hand recovery after a stroke.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Virtual Reality</intervention_name>
    <description>Virtual Reality Headset with Virtual Reality Applications</description>
    <arm_group_label>Immersive Virtual Reality</arm_group_label>
    <other_name>Oculus Quest</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -Veterans who have been diagnosed with&#xD;
&#xD;
          -  an acute ischemic or hemorrhagic stroke and&#xD;
&#xD;
          -  post-stroke are admitted to James A. Haley Veterans' Hospital inpatient rehabilitation&#xD;
&#xD;
          -  age 18-80 with stroke diagnosis verified by brain imaging.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to follow instructions or participate in immersive VR therapy due to&#xD;
             significant cognitive impairment,&#xD;
&#xD;
          -  History of seizures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Johanna E. Tran, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>James A. Haley Veterans' Hospital, Tampa, FL</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>James A. Haley Veterans' Hospital, Tampa, FL</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>January 4, 2023</last_update_submitted>
  <last_update_submitted_qc>January 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>stroke</keyword>
  <keyword>virtual reality</keyword>
  <keyword>rehabilitation</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>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 15, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/45/NCT04429945/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04429945
org study id: N3449-P
secondary id: I21RX003449
nct id: NCT04429945
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Over 15,000 Veterans are treated by the VA for stroke each year. A stroke means that part of
      the brain dies. Many people who have a stroke have difficulty with moving their arm, using
      their hand, and they have pain. Virtual reality is a video-game based treatment that may help
      people with stroke improve in these areas. Virtual reality involves using a computer and
      goggles to make a person feel like they are in a different world with new sights and sounds,
      relaxing on a beach where there is no pain, or playing the piano. In virtual reality, stroke
      patients can practice movement in a safe and motivating environment. For example, a person
      with stroke who has weakness in his/her arm can safely reach for plates in a virtual
      cupboard. In a virtual environment, the plates can't break. This study will help
      investigators to determine if people with strokes who are treated with virtual reality like
      it, and if they have less pain and better movement.
Background. Over the last decade, Virtual Reality (VR) has emerged as a cutting-edge
      technology in stroke rehabilitation. VR is defined as a type of user-computer interface that
      implements real-time simulation of an activity or environment allowing user interaction via
      multiple sensory modalities. VR interventions in a stroke population have been shown to be
      equivalent to usual care therapies and to enhance motor recovery when utilized as an adjunct.
      Significance/Impact/Innovation. This research will advance knowledge in rehabilitation
      research by testing state-of-the-art immersive 3-dimensional VR technology with the
      post-acute stroke Veteran population. The proposed project addresses: (1) the RR&D goal of
      maximizing functional recovery, (2) interest in non-pharmacological activity-based
      interventions for pain, and (3) supports modernization of the Veterans' Health Administration
      by incorporating technology-assisted rehabilitation.

      Specific Aims. (1) Determine the feasibility and tolerability of using a therapeutic VR
      platform in an inpatient comprehensive stroke rehabilitation program and (2) Estimate the
      initial clinical efficacy, or effect size, associated with the VR platform using APPS for
      distraction and upper extremity exercise for Veterans post-stroke.

      Methodology. Prospective within-subject pre-post pilot and survey study designs will be used.
      The target populations are (1) clinical staff who work on the Comprehensive Interdisciplinary
      Inpatient Rehabilitation Program (CIIRP) at the James A. Haley Veterans' Hospital (JAHVH) in
      Tampa (sample size N=10) and Veterans who are inpatients in the CIIRP (sample size N=10). The
      VR intervention consists of wearing a head mounted display that plays APPs ranging from music
      and nature views for pain distraction to more challenging strengthening and coordination
      activities such as playing the piano virtually. The intervention will last four weeks. The
      analytic approach will use descriptive statistics and qualitative methods. Aim 1 will
      administer a survey with open and closed ended questions to clinicians to examine the
      feasibility of successfully integrating a VR intervention into the flow of usual care.
      Feasibility constructs include adaptability (can VR intervention be adapted to an inpatient
      unit), patient need (do Veterans like and benefit from the intervention), and staff
      comments/impressions. Responses for each construct will be entered into an excel spreadsheet,
      one tab for each construct. Responses will then be grouped by similar content. Results will
      be reported as themes and subthemes. Aim 1 will also track patient VR tolerability by
      documenting and discussing patient complaints and adverse events. Tolerability data will be
      extracted from meeting minutes and grouped by similar occurrences. Results will be reported
      as themes and subthemes. Aim 2 will estimate effect sizes and degree of precision for upper
      extremity neurologic recovery, hand dexterity, and pain outcomes measured pre and post VR
      intervention. Neurologic recovery is measured with the Fugl-Meyer Assessment of Motor
      Recovery after Stroke-Upper Extremity, dexterity is measured with the Action Research Arm
      Test, and pain is measured with the Pain Outcomes Questionnaire-VA. Because standard scores
      do not necessarily translate to meaningful clinical differences (improvements), the
      investigators will identify the proportion of subjects who experience the minimal clinically
      important difference (MCID). Metrics will also be compared across outcomes.

      Next Steps/Implementation. Our next step is to work with our Program Partner in the Physical
      Medicine and Rehabilitation Office to conduct a large multi-site clinical trial that will
      incorporate the lessons learned from this feasibility pilot study to test the efficacy of a
      VR intervention in inpatient rehabilitation and transition to home evironments.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Once patients are enrolled, baseline data and pre-intervention outcome measures will be collected. APPs will be selected from the VR Toolkit that best address the individual patient's treatment goals.
Patients will be instructed in the use of the head mounted display with VR APPs. VR dosage will be two one-half hour sessions per therapy day. Patients can initiate use of a more challenging APPs that gradually includes hand/arm movement.
primary purpose: Treatment
masking: None (Open Label)
measure: Action Research Arm Test
time frame: 4 weeks
description: measures recovery of arm and hand function
measure: Fugl-Meyer Assessment Upper Extremity
time frame: 4 weeks
description: measures problems with sensation and movement
measure: Pain Outcomes Questionnaire-VA:Intake
time frame: baseline, pre-intervention
description: level of pain
measure: Pain Outcomes Questionnnaire-VA: Discharge
time frame: 4 weeks
description: level of pain
arm group label: Immersive Virtual Reality
arm group type: Experimental
description: A Virtual Reality headset will be used for 30 minutes twice per day outside of usual therapy times while in bed with bedrails raised. Virtual Reality games will be selected that will help with relaxation, pain, and arm and hand recovery after a stroke.
intervention type: Device
intervention name: Virtual Reality
description: Virtual Reality Headset with Virtual Reality Applications
arm group label: Immersive Virtual Reality
other name: Oculus Quest
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Johanna E. Tran, MD
role: Principal Investigator
affiliation: James A. Haley Veterans' Hospital, Tampa, FL
facility: 
country: United States
responsible party type: Sponsor
mesh term: Stroke
sharing ipd: No
provided document: 