<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/NCT03780296</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00121813</org_study_id>
    <nct_id>NCT03780296</nct_id>
  </id_info>
  <brief_title>Implementing Technology Enhanced Real Time Action Observation Therapy in Persons With Chronic Stroke</brief_title>
  <acronym>TERTAOT</acronym>
  <official_title>Implementing Technology Enhanced Real Time Action Observation Therapy in Persons With Chronic Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Michigan-Flint</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <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>
      This is a feasibility study to alter the Microsoft Kinect software to be used as a&#xD;
      rehabilitation tool. The prototype used is still in the early developing stage. The purpose&#xD;
      of this research study is to develop a prototype of altered Microsoft Kinect Software and&#xD;
      determine its use in improving the function of the study subjects' weaker extremities. The&#xD;
      altered software will allow a viewing of the mirror image of the involved limb as it is&#xD;
      moved. However, the image that is viewed will reflect normal movement even if the limb cannot&#xD;
      move normally. By viewing normal movement of the weaker limbs the &quot;mirror neuron&quot; network in&#xD;
      the brain will become activated and will ultimately improve the function of the weaker side.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 5, 2017</start_date>
  <completion_date type="Actual">September 26, 2018</completion_date>
  <primary_completion_date type="Actual">September 26, 2018</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>Single group pre-test/post-test design</intervention_model_description>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Motor Activity Log (MAL)</measure>
    <time_frame>5 months</time_frame>
    <description>MAL measures participants overall use or increased use and quality of use of affected upper limb</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in 9 Hole Peg Test (9HPT)</measure>
    <time_frame>5 months</time_frame>
    <description>9 HPT is a timed standardized measure participants overall function of dexterity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in 10 Meter Walk Test (10mWT)</measure>
    <time_frame>5 months</time_frame>
    <description>The 10mWT is a standardized measure used to assess participants timed walking speed in meters per second over a short distance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Functional Reach Test (FRT)</measure>
    <time_frame>5 months</time_frame>
    <description>The functional reach test is a standardized measure assessing the participants ability to reach forward with unaffected arm</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Timed Up and Go (TUG)</measure>
    <time_frame>5 months</time_frame>
    <description>The TUG is a standardized measure which assesses participants mobility, balance, walking ability, and fall risk in older adults</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in 5 Time Sit to Stand (5xSS)</measure>
    <time_frame>5 months</time_frame>
    <description>This is a standardized measure assessing participants functional lower limb strength.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Chronic Stroke</condition>
  <condition>Hemiplegia</condition>
  <condition>Hemiparesis</condition>
  <condition>Paralysis</condition>
  <arm_group>
    <arm_group_label>Real-Time Action Observation with augmented Kinect</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive 30 minutes of the augmented kinect software in real-time undergoing an exercise protocol involving seated upper extremity exercises, seated lower extremity exercises and standing upper extremity exercises.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Real-time action observation with augmented Kinect</intervention_name>
    <description>Participants will receive 30 minutes of the augmented kinect software in real-time undergoing an exercise protocol involving seated upper extremity exercises, seated lower extremity exercises and standing upper extremity exercises.</description>
    <arm_group_label>Real-Time Action Observation with augmented Kinect</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  - Adults 40 years of age and older having had a stroke greater than 6-months post&#xD;
             onset&#xD;
&#xD;
          -  Able to follow commands in English&#xD;
&#xD;
          -  Medically stable and without acute illness, such as infection, inflammation, ongoing&#xD;
             chest pain, or short of breath with walking and light activities&#xD;
&#xD;
          -  Able to stand up off of a standard height chair (16-18 inches)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - Cognitive impairment as measured by a score below 24/30 on Mini Mental State&#xD;
             Examination&#xD;
&#xD;
          -  A diagnoses of cancer involving the nervous or musculoskeletal system&#xD;
&#xD;
          -  Severe pain in arms, legs, or spine measured by &gt;6/10 using Verbal Numerical Pain&#xD;
             Rating Scale that prevents them from standing or walking independently&#xD;
&#xD;
          -  Diagnoses of other neurological diseases except for stroke, such as spinal cord injury&#xD;
             or Parkinson's disease etc.&#xD;
&#xD;
          -  Individuals at the advanced stage of a disease and with less than 12 months to live.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hendrika L Lietz, PT, DPT, NCS</last_name>
    <role>Study Chair</role>
    <affiliation>Michigan Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MedRehab Canton</name>
      <address>
        <city>Canton</city>
        <state>Michigan</state>
        <zip>48187</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 17, 2018</last_update_submitted>
  <last_update_submitted_qc>December 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Mary Roberts</investigator_full_name>
    <investigator_title>Physical Therapist</investigator_title>
  </responsible_party>
  <keyword>Kinect</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Virtual reality</keyword>
  <keyword>Mirror therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Paralysis</mesh_term>
    <mesh_term>Hemiplegia</mesh_term>
    <mesh_term>Paresis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Dissemination at local, state and national conferences via platform and poster presentations.&#xD;
Share upon request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
  </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/NCT03780296
org study id: HUM00121813
nct id: NCT03780296
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This is a feasibility study to alter the Microsoft Kinect software to be used as a
      rehabilitation tool. The prototype used is still in the early developing stage. The purpose
      of this research study is to develop a prototype of altered Microsoft Kinect Software and
      determine its use in improving the function of the study subjects' weaker extremities. The
      altered software will allow a viewing of the mirror image of the involved limb as it is
      moved. However, the image that is viewed will reflect normal movement even if the limb cannot
      move normally. By viewing normal movement of the weaker limbs the "mirror neuron" network in
      the brain will become activated and will ultimately improve the function of the weaker side.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single group pre-test/post-test design
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Change in Motor Activity Log (MAL)
time frame: 5 months
description: MAL measures participants overall use or increased use and quality of use of affected upper limb
measure: Change in 9 Hole Peg Test (9HPT)
time frame: 5 months
description: 9 HPT is a timed standardized measure participants overall function of dexterity.
measure: Change in 10 Meter Walk Test (10mWT)
time frame: 5 months
description: The 10mWT is a standardized measure used to assess participants timed walking speed in meters per second over a short distance
measure: Change in Functional Reach Test (FRT)
time frame: 5 months
description: The functional reach test is a standardized measure assessing the participants ability to reach forward with unaffected arm
measure: Change in Timed Up and Go (TUG)
time frame: 5 months
description: The TUG is a standardized measure which assesses participants mobility, balance, walking ability, and fall risk in older adults
measure: Change in 5 Time Sit to Stand (5xSS)
time frame: 5 months
description: This is a standardized measure assessing participants functional lower limb strength.
arm group label: Real-Time Action Observation with augmented Kinect
arm group type: Experimental
description: Participants will receive 30 minutes of the augmented kinect software in real-time undergoing an exercise protocol involving seated upper extremity exercises, seated lower extremity exercises and standing upper extremity exercises.
intervention type: Device
intervention name: Real-time action observation with augmented Kinect
description: Participants will receive 30 minutes of the augmented kinect software in real-time undergoing an exercise protocol involving seated upper extremity exercises, seated lower extremity exercises and standing upper extremity exercises.
arm group label: Real-Time Action Observation with augmented Kinect
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Hendrika L Lietz, PT, DPT, NCS
role: Study Chair
affiliation: Michigan Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Mary Roberts
investigator title: Physical Therapist
mesh term: Stroke
mesh term: Paralysis
mesh term: Hemiplegia
mesh term: Paresis
sharing ipd: Yes
ipd description: Dissemination at local, state and national conferences via platform and poster presentations.
Share upon request.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)