<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/NCT03229733</url>
  </required_header>
  <id_info>
    <org_study_id>CMRPG8E0931</org_study_id>
    <nct_id>NCT03229733</nct_id>
  </id_info>
  <brief_title>Design and Evaluation the Effects of Kinect-based Computer Games for U/E Training in Chronic Stroke Patients</brief_title>
  <official_title>Design and Evaluation the Feasibility, Effects of Kinect-based Computer Games for Rehabilitation Training of Upper Extremity Function in Patients With Chronic Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aims of this study are to (i) develop exergames by using Kinect system for training UE&#xD;
      function in patient with stroke; and (ii) to test the game's feasibility and effects in a&#xD;
      group of patient with chronic stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Exercise based computer games can facilitate high volume complex task practice, enhance&#xD;
      feedback of movement and increase motivation of participants. Those effects are difficult to&#xD;
      achieve with standard rehabilitation therapy. The Kinect system is a camera-based controller&#xD;
      which a player can use to directly control a game through body movement without the need for&#xD;
      handheld controllers. Using Kinect to capture movement is a feasible way to help patients who&#xD;
      have difficulties to hold controllers to play exergames. Scratch 2.0 is a programming&#xD;
      language for kids from the MIT Media Laboratory. It is easy to use for game designing.&#xD;
      Kinect2Scratch allows data from the Microsoft Kinect controller to be sent to Scratch, This&#xD;
      means that game programs can be designed with motion control. The aims of this study were to&#xD;
      i) develop exergames by using Scratch and Kinect system for training upper extremity function&#xD;
      in patient with stroke; and ii) to test the game's feasibility and effects in a group of&#xD;
      patient with chronic stroke.&#xD;
&#xD;
      This program will be done within two years. During the first year, investigators will design&#xD;
      several exergames which are suitable for training upper extremity function in patient with&#xD;
      stroke. Investigators will have several experts meetings, involved by physiatrists,&#xD;
      occupational therapists and engineers to design the game. When a prototype game is created,&#xD;
      investigators will invite two to four patients with stroke to pilot test the game. The game&#xD;
      design will be completed till patients and therapists satisfy the design.&#xD;
&#xD;
      During the 2nd year, investigators will test the feasibility and effects of the exergames by&#xD;
      doing a pilot randomized control trial. Investigators will recruit 60 patients with chronic&#xD;
      stroke who are admitted to a rehabilitation ward for outpatient rehabilitation, and will&#xD;
      randomize participants to experiment or control group. All participants will receive PT and&#xD;
      OT training as routine. The additional intervention either exergames or conventional OT will&#xD;
      be delivered for 8 weeks with 3 training sessions/week of up to 30 minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2015</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</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>Motor function assessed on Fugl-Meyer Assessment (FMA)</measure>
    <time_frame>Change from baseline at 5 months</time_frame>
    <description>The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The amount of movement assessed on Actigraph Assessment</measure>
    <time_frame>Change from baseline at 2 months</time_frame>
    <description>The outcome will be measured at 2 time points: 0 week, and 8 weeks after recruitment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The upper extremity motor ability assessed on Wolf Motor Function Test (WMFT)</measure>
    <time_frame>Change from baseline at 5 months</time_frame>
    <description>The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The quality of movement and amount of use assessed on Motor Activity Log (MAL)</measure>
    <time_frame>Change from baseline at 5 months</time_frame>
    <description>The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The instrumental activities of daily living assessed on Nottingham Extended Activities of Daily Living Scale (NEADL)</measure>
    <time_frame>Change from baseline at 5 months</time_frame>
    <description>The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The relevant for upper-extremity function self-report questionnaire on Stroke Impact Scale (SIS)</measure>
    <time_frame>Change from baseline at 5 months</time_frame>
    <description>The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Standing balance assessed on The Functional reach test (FR)</measure>
    <time_frame>Change from baseline at 5 months</time_frame>
    <description>The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle power assessed on Medical Research Council Scale (MRC)</measure>
    <time_frame>Change from baseline at 5 months</time_frame>
    <description>The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized to the experimental group participate in exergames training with Kinect. The supervised OT chooses different games according to the patient's needs and abilities. During therapy patients are at sitting position. The game program will be adjusted when patients got improvement. After 30 minutes of exergames training, participants will receive a 30-minutes of traditional occupational therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in the control group will receive individually tailored traditional occupational therapy consisting of the similar movement and dose as the experimental group doing by using the traditional equipment, such as climbing bar.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Kinect</intervention_name>
    <description>Receive Kinect games training for 30 minutes. There are 3 sections for 1 week; the intervention period will be 8 weeks</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Traditional occupational therapy</intervention_name>
    <description>Patients will receive individually tailored conventional training consisting of the similar movement and dose by using the traditional equipment, such as climbing bar.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  First ever ischemic or hemorrhagic stroke or former stroke without any significant&#xD;
             residual motor impairment&#xD;
&#xD;
          -  3 months post stroke&#xD;
&#xD;
          -  Impaired arm motor function at Brunnstrom stage 3-5&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe cognitive impairment defined as &lt; 20 on Mini Mental State Examination&#xD;
&#xD;
          -  visual disorders or neglect limiting the ability to comply with treatment regimen&#xD;
&#xD;
          -  orthopedic problem or other neurological diagnosis that makes the UE dysfunction.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jen-Wen Hung</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <results_reference>
    <citation>Noorkoiv M, Rodgers H, Price CI. Accelerometer measurement of upper extremity movement after stroke: a systematic review of clinical studies. J Neuroeng Rehabil. 2014 Oct 9;11:144. doi: 10.1186/1743-0003-11-144.</citation>
    <PMID>25297823</PMID>
  </results_reference>
  <results_reference>
    <citation>Adams RJ, Lichter MD, Krepkovich ET, Ellington A, White M, Diamond PT. Assessing upper extremity motor function in practice of virtual activities of daily living. IEEE Trans Neural Syst Rehabil Eng. 2015 Mar;23(2):287-96. doi: 10.1109/TNSRE.2014.2360149. Epub 2014 Sep 24.</citation>
    <PMID>25265612</PMID>
  </results_reference>
  <results_reference>
    <citation>Wolf SL, Catlin PA, Ellis M, Archer AL, Morgan B, Piacentino A. Assessing Wolf motor function test as outcome measure for research in patients after stroke. Stroke. 2001 Jul;32(7):1635-9. doi: 10.1161/01.str.32.7.1635.</citation>
    <PMID>11441212</PMID>
  </results_reference>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>July 23, 2017</study_first_submitted>
  <study_first_submitted_qc>July 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>July 17, 2018</last_update_submitted>
  <last_update_submitted_qc>July 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Kinect</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Upper limbs</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>
  <pending_results>
    <submitted>February 18, 2019</submitted>
    <returned>March 12, 2019</returned>
  </pending_results>
  <!-- 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/NCT03229733
org study id: CMRPG8E0931
nct id: NCT03229733
lead sponsor: 
has dmc: No
The aims of this study are to (i) develop exergames by using Kinect system for training UE
      function in patient with stroke; and (ii) to test the game's feasibility and effects in a
      group of patient with chronic stroke.
Exercise based computer games can facilitate high volume complex task practice, enhance
      feedback of movement and increase motivation of participants. Those effects are difficult to
      achieve with standard rehabilitation therapy. The Kinect system is a camera-based controller
      which a player can use to directly control a game through body movement without the need for
      handheld controllers. Using Kinect to capture movement is a feasible way to help patients who
      have difficulties to hold controllers to play exergames. Scratch 2.0 is a programming
      language for kids from the MIT Media Laboratory. It is easy to use for game designing.
      Kinect2Scratch allows data from the Microsoft Kinect controller to be sent to Scratch, This
      means that game programs can be designed with motion control. The aims of this study were to
      i) develop exergames by using Scratch and Kinect system for training upper extremity function
      in patient with stroke; and ii) to test the game's feasibility and effects in a group of
      patient with chronic stroke.

      This program will be done within two years. During the first year, investigators will design
      several exergames which are suitable for training upper extremity function in patient with
      stroke. Investigators will have several experts meetings, involved by physiatrists,
      occupational therapists and engineers to design the game. When a prototype game is created,
      investigators will invite two to four patients with stroke to pilot test the game. The game
      design will be completed till patients and therapists satisfy the design.

      During the 2nd year, investigators will test the feasibility and effects of the exergames by
      doing a pilot randomized control trial. Investigators will recruit 60 patients with chronic
      stroke who are admitted to a rehabilitation ward for outpatient rehabilitation, and will
      randomize participants to experiment or control group. All participants will receive PT and
      OT training as routine. The additional intervention either exergames or conventional OT will
      be delivered for 8 weeks with 3 training sessions/week of up to 30 minutes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Motor function assessed on Fugl-Meyer Assessment (FMA)
time frame: Change from baseline at 5 months
description: The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
measure: The amount of movement assessed on Actigraph Assessment
time frame: Change from baseline at 2 months
description: The outcome will be measured at 2 time points: 0 week, and 8 weeks after recruitment.
measure: The upper extremity motor ability assessed on Wolf Motor Function Test (WMFT)
time frame: Change from baseline at 5 months
description: The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
measure: The quality of movement and amount of use assessed on Motor Activity Log (MAL)
time frame: Change from baseline at 5 months
description: The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
measure: The instrumental activities of daily living assessed on Nottingham Extended Activities of Daily Living Scale (NEADL)
time frame: Change from baseline at 5 months
description: The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
measure: The relevant for upper-extremity function self-report questionnaire on Stroke Impact Scale (SIS)
time frame: Change from baseline at 5 months
description: The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
measure: Standing balance assessed on The Functional reach test (FR)
time frame: Change from baseline at 5 months
description: The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
measure: Muscle power assessed on Medical Research Council Scale (MRC)
time frame: Change from baseline at 5 months
description: The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
arm group label: Experimental group
arm group type: Experimental
description: Patients randomized to the experimental group participate in exergames training with Kinect. The supervised OT chooses different games according to the patient's needs and abilities. During therapy patients are at sitting position. The game program will be adjusted when patients got improvement. After 30 minutes of exergames training, participants will receive a 30-minutes of traditional occupational therapy.
arm group label: Control group
arm group type: Active Comparator
description: Patients in the control group will receive individually tailored traditional occupational therapy consisting of the similar movement and dose as the experimental group doing by using the traditional equipment, such as climbing bar.
intervention type: Device
intervention name: Kinect
description: Receive Kinect games training for 30 minutes. There are 3 sections for 1 week; the intervention period will be 8 weeks
arm group label: Experimental group
intervention type: Behavioral
intervention name: Traditional occupational therapy
description: Patients will receive individually tailored conventional training consisting of the similar movement and dose by using the traditional equipment, such as climbing bar.
arm group label: Control group
arm group label: Experimental group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jen-Wen Hung
role: Principal Investigator
affiliation: Chang Gung Memorial Hospital
citation: Noorkoiv M, Rodgers H, Price CI. Accelerometer measurement of upper extremity movement after stroke: a systematic review of clinical studies. J Neuroeng Rehabil. 2014 Oct 9;11:144. doi: 10.1186/1743-0003-11-144.
PMID: 25297823
citation: Adams RJ, Lichter MD, Krepkovich ET, Ellington A, White M, Diamond PT. Assessing upper extremity motor function in practice of virtual activities of daily living. IEEE Trans Neural Syst Rehabil Eng. 2015 Mar;23(2):287-96. doi: 10.1109/TNSRE.2014.2360149. Epub 2014 Sep 24.
PMID: 25265612
citation: Wolf SL, Catlin PA, Ellis M, Archer AL, Morgan B, Piacentino A. Assessing Wolf motor function test as outcome measure for research in patients after stroke. Stroke. 2001 Jul;32(7):1635-9. doi: 10.1161/01.str.32.7.1635.
PMID: 11441212
responsible party type: Sponsor
mesh term: Stroke
sharing ipd: No
submitted: February 18, 2019
returned: March 12, 2019