<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/NCT03039764</url>
  </required_header>
  <id_info>
    <org_study_id>2016-6572</org_study_id>
    <nct_id>NCT03039764</nct_id>
  </id_info>
  <brief_title>Effects of Virtual Reality Based Rehabilitation in Acute Stroke Patients in an Inpatient Rehab Setting</brief_title>
  <official_title>The Comparison Study of Virtual Reality Rehabilitation With Standard Occupational Therapy Versus Standard Occupational Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Montefiore Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Montefiore Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the effects of virtual reality-based rehabilitation (Neofect Glove) for newly&#xD;
      diagnosed cognitively intact adult dominant hemisphere stroke patients with paresis of their&#xD;
      hand in supplementation with conventional occupational therapy to assess whether it improves&#xD;
      motor function and speed recovery during inpatient rehabilitation versus conventional&#xD;
      occupational therapy alone. Also, what impact does this have on quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The American Stroke Association states that stroke is 5th leading cause of death in the&#xD;
      United States and one of the leading causes of disability and loss of motor function.&#xD;
      Approximately 80% of stroke survivors have upper extremity limitations where the distal upper&#xD;
      extremity motor function is severely affected and is the last body part to recover.&#xD;
      Restoration of arm function is essential to regaining activities of daily living (ADL) such&#xD;
      as holding objects like utensils, turning a doorknob, writing or telephone use. Literature&#xD;
      search shows that intensive and repetitive training may be necessary to modify neural&#xD;
      organization and recover functional motor skills. Along with traditional rehabilitation&#xD;
      methods, virtual reality (VR) based rehabilitation has emerged in recent years. VR-based&#xD;
      rehabilitation is more intensive, of longer duration and more repetitive. Using VR&#xD;
      rehabilitation, repetitive dull exercises can turn into a more challenging and motivating&#xD;
      tasks such as games. Moreover, VR-based rehabilitation can provide a quantitative measure of&#xD;
      the rehabilitation progress.&#xD;
&#xD;
      The investigators propose a study comparing conventional occupational services versus virtual&#xD;
      reality-based rehabilitation intervention for participants during acute phase of stroke in&#xD;
      the inpatient rehabilitation setting. The investigators hypothesize that by using VRA, will&#xD;
      see a significant increase in the overall motor function, shorter hospital course and&#xD;
      improved quality of life for the participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Paused due to COVID and the study has expired. The PI left the institution in 2021 and another&#xD;
    PI has not been assigned.&#xD;
  </why_stopped>
  <start_date type="Actual">April 30, 2018</start_date>
  <completion_date type="Anticipated">August 19, 2022</completion_date>
  <primary_completion_date type="Actual">August 19, 2021</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants treated with occupational therapy and with VR device will be assesed by Wolf Motor Function Test</measure>
    <time_frame>3 Months</time_frame>
    <description>Scores on the Wolf Motor Function test measured at baseline and after therapy will be summarized using standard descriptive statistics for each treatment group. Data will be collected by designated research fellow.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants treated with occupational therapy and with VR device will be assesed by Michigan Hand Outcome Questionnaire</measure>
    <time_frame>3 Months</time_frame>
    <description>Scores of Michigan Hand Outcome Questionnaire measured at baseline and after therapy will be summarized using standard descriptive statistics for each treatment group. Data will be collected by designated research fellow.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Stroke Syndrome</condition>
  <condition>Hemiplegia</condition>
  <arm_group>
    <arm_group_label>Standard occupational therapy</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group will receiving standard occupational therapy for the treatment of acute stroke.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SOT plus VR Rapael</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will receive virtual reality-based rehabilitation intervention wearing Rapael glove made by Neofect supplemented with standard occupational services per conventional protocols.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Rapael</intervention_name>
    <description>This group will receive virtual reality-based rehabilitation intervention wearing Rapael glove made by Neofect supplemented with standard occupational services per conventional protocols.</description>
    <arm_group_label>SOT plus VR Rapael</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Minimum age of 18 years' old&#xD;
&#xD;
          -  Unilateral upper extremity functional deficits after stroke&#xD;
&#xD;
          -  First ever clinical diagnosis of stroke in the dominant hemisphere&#xD;
&#xD;
          -  Diagnosis of ischemic or hemorrhagic stroke with unilateral paresis of dominant hand&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age less than 18 years' old&#xD;
&#xD;
          -  Cognitive impairment resulting in inability to participate&#xD;
&#xD;
          -  Severe aphasia resulting in inability to communicate to give consent or participate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Burke rehabilitation Hospital</name>
      <address>
        <city>White Plains</city>
        <state>New York</state>
        <zip>10605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>May 4, 2022</last_update_submitted>
  <last_update_submitted_qc>May 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2022</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>
    <mesh_term>Hemiplegia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Will not share IPD</ipd_description>
  </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/NCT03039764
org study id: 2016-6572
nct id: NCT03039764
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
To evaluate the effects of virtual reality-based rehabilitation (Neofect Glove) for newly
      diagnosed cognitively intact adult dominant hemisphere stroke patients with paresis of their
      hand in supplementation with conventional occupational therapy to assess whether it improves
      motor function and speed recovery during inpatient rehabilitation versus conventional
      occupational therapy alone. Also, what impact does this have on quality of life.
The American Stroke Association states that stroke is 5th leading cause of death in the
      United States and one of the leading causes of disability and loss of motor function.
      Approximately 80% of stroke survivors have upper extremity limitations where the distal upper
      extremity motor function is severely affected and is the last body part to recover.
      Restoration of arm function is essential to regaining activities of daily living (ADL) such
      as holding objects like utensils, turning a doorknob, writing or telephone use. Literature
      search shows that intensive and repetitive training may be necessary to modify neural
      organization and recover functional motor skills. Along with traditional rehabilitation
      methods, virtual reality (VR) based rehabilitation has emerged in recent years. VR-based
      rehabilitation is more intensive, of longer duration and more repetitive. Using VR
      rehabilitation, repetitive dull exercises can turn into a more challenging and motivating
      tasks such as games. Moreover, VR-based rehabilitation can provide a quantitative measure of
      the rehabilitation progress.

      The investigators propose a study comparing conventional occupational services versus virtual
      reality-based rehabilitation intervention for participants during acute phase of stroke in
      the inpatient rehabilitation setting. The investigators hypothesize that by using VRA, will
      see a significant increase in the overall motor function, shorter hospital course and
      improved quality of life for the participants.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Number of participants treated with occupational therapy and with VR device will be assesed by Wolf Motor Function Test
time frame: 3 Months
description: Scores on the Wolf Motor Function test measured at baseline and after therapy will be summarized using standard descriptive statistics for each treatment group. Data will be collected by designated research fellow.
measure: Number of participants treated with occupational therapy and with VR device will be assesed by Michigan Hand Outcome Questionnaire
time frame: 3 Months
description: Scores of Michigan Hand Outcome Questionnaire measured at baseline and after therapy will be summarized using standard descriptive statistics for each treatment group. Data will be collected by designated research fellow.
arm group label: Standard occupational therapy
arm group type: No Intervention
description: This group will receiving standard occupational therapy for the treatment of acute stroke.
arm group label: SOT plus VR Rapael
arm group type: Experimental
description: This group will receive virtual reality-based rehabilitation intervention wearing Rapael glove made by Neofect supplemented with standard occupational services per conventional protocols.
intervention type: Device
intervention name: Rapael
description: This group will receive virtual reality-based rehabilitation intervention wearing Rapael glove made by Neofect supplemented with standard occupational services per conventional protocols.
arm group label: SOT plus VR Rapael
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Stroke
mesh term: Hemiplegia
sharing ipd: No
ipd description: Will not share IPD