<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/NCT03811275</url>
  </required_header>
  <id_info>
    <org_study_id>IdahoSU</org_study_id>
    <nct_id>NCT03811275</nct_id>
  </id_info>
  <brief_title>Task or Virtual Reality Intervention for Improving UE Function</brief_title>
  <official_title>Functional Outcomes Following Task-based and VR Action Observation Interventions for Adults With Chronic Hemiparesis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Idaho State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Idaho State University</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>
      People with one arm that does not function well due to a stroke, head injury, or cerebral&#xD;
      palsy, and a fully functional other arm, will be randomly assigned to receive one of the two&#xD;
      interventions first, followed by the other intervention. The two interventions include a&#xD;
      task-based intervention and a virtual reality intervention that provides a reflected image of&#xD;
      the involved arm. The task-based intervention will consist of setting up activities of&#xD;
      interest to be done using the involved arm and structuring practice and meaningful feedback&#xD;
      to assist learning. The virtual reality intervention will consist of the person wearing the&#xD;
      virtual reality device and practicing virtual tasks using the intact arm while seeing the&#xD;
      involved arm. Intervention sessions will last approximately 30 minutes and will be held 3&#xD;
      times/week for 3 weeks each for a total of 9 sessions for each intervention. Testing of the&#xD;
      involved arm's function will be done before the interventions, after receiving 9 sessions of&#xD;
      each intervention, and one month after completing the second intervention received.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Potential participants will be screened for age, history of stroke, brain injury, or cerebral&#xD;
      palsy, and having one functional arm and one poorly functioning arm by phone. Those who meet&#xD;
      the basic criteria will be scheduled for an Intake Evaluation consisting of obtaining&#xD;
      voluntary informed consent, complete a demographic survey, visual field testing, cognitive&#xD;
      screening, perceptual testing, and an arm/hand function test. Participants who meet the&#xD;
      inclusion criteria will be scheduled for a Preliminary Evaluation.&#xD;
&#xD;
      The Preliminary Evaluation will measure the current motor control ability, perception of&#xD;
      level of disability, and amount of active and passive motion in the involved arm.&#xD;
&#xD;
      Participants will participate in the first form of intervention (randomly assigned) for three&#xD;
      30 minute sessions per week for 3 weeks (total of 9 sessions) and be re-evaluated using the&#xD;
      same tests conducted during the Preliminary Evaluation with the addition of the arm/hand&#xD;
      function test conducted during the initial screening.&#xD;
&#xD;
      Participants will participate in the second form of intervention for three 30 minute sessions&#xD;
      per week for 3 weeks (total of 9 sessions) and be re-evaluated using the same tests conducted&#xD;
      following the first intervention.&#xD;
&#xD;
      One month after completing the second form of intervention, participants will be re-evaluated&#xD;
      using the same tests used following the second intervention and will also receive a&#xD;
      semi-structured interview regarding their thoughts and experiences during the study and their&#xD;
      perceptions of the outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 8, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>Crossover Assignment</intervention_model>
    <intervention_model_description>All participants will receive both interventions (A and B) and will be randomly assigned to the sequence in which they receive them (AB or BA).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>The occupational therapist providing all of the functional assessments will be blinded to sequence of interventions provided.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Fugl-Meyer Assessment (UE portion)</measure>
    <time_frame>1st week, 4 weeks, 8 weeks, 12 weeks</time_frame>
    <description>Performance-based measure of arm impairment post stroke; a positive change in score indicates improvement</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Box &amp; Block Test</measure>
    <time_frame>1st week, 4 weeks, 8 weeks, 12 weeks</time_frame>
    <description>Measures unilateral gross manual dexterity; a positive change in score indicates improvement</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Stroke Impact Scale 3.0</measure>
    <time_frame>1st week, 4 weeks, 8 weeks, 12 weeks</time_frame>
    <description>Self-report health status measure; The Total Score and Subscale Scores range from 0 - 100 with higher scores indicating less perceived impact of the stroke on function and participation (positive change in scores indicate improvement)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Active and Passive Range of Motion</measure>
    <time_frame>1st week, 4 weeks, 8 weeks, 12 weeks</time_frame>
    <description>Goniometric measures of active and passive range of motion of the elbow extension, wrist extension, and thumb radial abduction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Semi-structured interview</measure>
    <time_frame>12 weeks</time_frame>
    <description>Qualitative measure of the participant's perception of change in arm function after participating in the study.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Upper Extremity Paresis</condition>
  <condition>Hemiplegia and/or Hemiparesis Following Stroke</condition>
  <condition>Hemiplegic Cerebral Palsy</condition>
  <arm_group>
    <arm_group_label>Sequence #1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive nine 30 minute sessions (over 3 weeks) of intervention A followed by nine 30 minute sessions (over 3 weeks) of intervention B.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence #2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive nine 30 minute sessions (over 3 weeks) of intervention B followed by nine 30 minute sessions (over 3 weeks) of intervention B.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Virtual Reality (A) then Task (B)</intervention_name>
    <description>Participants will use their intact arm to perform virtual reality tasks while perceiving a reflected virtual image of their paretic arm.</description>
    <arm_group_label>Sequence #1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Task (B) then Virtual Reality (A)</intervention_name>
    <description>Participants will use their paretic arm to perform real tasks in a structured environment, with a practice and feedback schedule organized by a physical or occupational therapist, or graduate student.</description>
    <arm_group_label>Sequence #2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 - 89 years old&#xD;
&#xD;
          -  One arm not fully functional due to a stroke, brain injury, or cerebral palsy&#xD;
&#xD;
          -  More than 1 year since neurologic even that impaired arm function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cognitive impairment&#xD;
&#xD;
          -  visual field loss (homonymous hemianopsia)&#xD;
&#xD;
          -  perceptual deficits (MVPT4 lower than 2 standard deviations from the norm)&#xD;
&#xD;
          -  Seizure disorder&#xD;
&#xD;
          -  Currently receiving rehabilitation services (PT or OT) for the involved arm.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nancy L Devine, PT, DPT, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Idaho State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nancy L Devine</name>
      <address>
        <city>Pocatello</city>
        <state>Idaho</state>
        <zip>83209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>May 22, 2023</last_update_submitted>
  <last_update_submitted_qc>May 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>upper extremity recovery of function</keyword>
  <keyword>action observation</keyword>
  <keyword>virtual reality</keyword>
  <keyword>task-based intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Palsy</mesh_term>
    <mesh_term>Hemiplegia</mesh_term>
    <mesh_term>Paresis</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/NCT03811275
org study id: IdahoSU
nct id: NCT03811275
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
People with one arm that does not function well due to a stroke, head injury, or cerebral
      palsy, and a fully functional other arm, will be randomly assigned to receive one of the two
      interventions first, followed by the other intervention. The two interventions include a
      task-based intervention and a virtual reality intervention that provides a reflected image of
      the involved arm. The task-based intervention will consist of setting up activities of
      interest to be done using the involved arm and structuring practice and meaningful feedback
      to assist learning. The virtual reality intervention will consist of the person wearing the
      virtual reality device and practicing virtual tasks using the intact arm while seeing the
      involved arm. Intervention sessions will last approximately 30 minutes and will be held 3
      times/week for 3 weeks each for a total of 9 sessions for each intervention. Testing of the
      involved arm's function will be done before the interventions, after receiving 9 sessions of
      each intervention, and one month after completing the second intervention received.
Potential participants will be screened for age, history of stroke, brain injury, or cerebral
      palsy, and having one functional arm and one poorly functioning arm by phone. Those who meet
      the basic criteria will be scheduled for an Intake Evaluation consisting of obtaining
      voluntary informed consent, complete a demographic survey, visual field testing, cognitive
      screening, perceptual testing, and an arm/hand function test. Participants who meet the
      inclusion criteria will be scheduled for a Preliminary Evaluation.

      The Preliminary Evaluation will measure the current motor control ability, perception of
      level of disability, and amount of active and passive motion in the involved arm.

      Participants will participate in the first form of intervention (randomly assigned) for three
      30 minute sessions per week for 3 weeks (total of 9 sessions) and be re-evaluated using the
      same tests conducted during the Preliminary Evaluation with the addition of the arm/hand
      function test conducted during the initial screening.

      Participants will participate in the second form of intervention for three 30 minute sessions
      per week for 3 weeks (total of 9 sessions) and be re-evaluated using the same tests conducted
      following the first intervention.

      One month after completing the second form of intervention, participants will be re-evaluated
      using the same tests used following the second intervention and will also receive a
      semi-structured interview regarding their thoughts and experiences during the study and their
      perceptions of the outcomes.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: All participants will receive both interventions (A and B) and will be randomly assigned to the sequence in which they receive them (AB or BA).
primary purpose: Treatment
masking: Single (Investigator)
masking description: The occupational therapist providing all of the functional assessments will be blinded to sequence of interventions provided.
measure: Change in Fugl-Meyer Assessment (UE portion)
time frame: 1st week, 4 weeks, 8 weeks, 12 weeks
description: Performance-based measure of arm impairment post stroke; a positive change in score indicates improvement
measure: Change in Box & Block Test
time frame: 1st week, 4 weeks, 8 weeks, 12 weeks
description: Measures unilateral gross manual dexterity; a positive change in score indicates improvement
measure: Change in Stroke Impact Scale 3.0
time frame: 1st week, 4 weeks, 8 weeks, 12 weeks
description: Self-report health status measure; The Total Score and Subscale Scores range from 0 - 100 with higher scores indicating less perceived impact of the stroke on function and participation (positive change in scores indicate improvement)
measure: Change in Active and Passive Range of Motion
time frame: 1st week, 4 weeks, 8 weeks, 12 weeks
description: Goniometric measures of active and passive range of motion of the elbow extension, wrist extension, and thumb radial abduction.
measure: Semi-structured interview
time frame: 12 weeks
description: Qualitative measure of the participant's perception of change in arm function after participating in the study.
arm group label: Sequence #1
arm group type: Experimental
description: Participants will receive nine 30 minute sessions (over 3 weeks) of intervention A followed by nine 30 minute sessions (over 3 weeks) of intervention B.
arm group label: Sequence #2
arm group type: Experimental
description: Participants will receive nine 30 minute sessions (over 3 weeks) of intervention B followed by nine 30 minute sessions (over 3 weeks) of intervention B.
intervention type: Behavioral
intervention name: Virtual Reality (A) then Task (B)
description: Participants will use their intact arm to perform virtual reality tasks while perceiving a reflected virtual image of their paretic arm.
arm group label: Sequence #1
intervention type: Behavioral
intervention name: Task (B) then Virtual Reality (A)
description: Participants will use their paretic arm to perform real tasks in a structured environment, with a practice and feedback schedule organized by a physical or occupational therapist, or graduate student.
arm group label: Sequence #2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: No
last name: Nancy L Devine, PT, DPT, MS
role: Principal Investigator
affiliation: Idaho State University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cerebral Palsy
mesh term: Hemiplegia
mesh term: Paresis
sharing ipd: No