<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/NCT04436237</url>
  </required_header>
  <id_info>
    <org_study_id>A-ER-108-183</org_study_id>
    <nct_id>NCT04436237</nct_id>
  </id_info>
  <brief_title>Effect of Lower Limb Exproprioception Training in Virtual Environment on Locomotion Performance in Stroke Patients</brief_title>
  <official_title>Effect of Lower Limb Exproprioception Training in Virtual Environment on Locomotion Performance in Stroke Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cheng Kung University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cheng Kung 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>
      The purpose of this study is to determine if a virtual reality training of foot placement&#xD;
      with or without visual cues about the location of the foot in the environment would improve&#xD;
      locomotion-related function in persons in the chronic stage of stroke. Participants were&#xD;
      randomly assigned to receive twice per week, for a total of 2 weeks' training with visual&#xD;
      cues (control group) or without (experimental group). It was hypothesized that the&#xD;
      experimental group would be able to place the foot closer to the target when stepping and&#xD;
      have more symmetrical gait. So far, 22 stroke patients completed the experiment. Preliminary&#xD;
      results support the hypothesis. This project is still ongoing.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 26, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 10, 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>foot placement accuracy (cm)</measure>
    <time_frame>2 weeks</time_frame>
    <description>The distance between the foot and the target in various stepping tasks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>gait symmetry</measure>
    <time_frame>2 weeks</time_frame>
    <description>ratio of the two leg step lengths</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>exproprioception (cm)</measure>
    <time_frame>2 weeks</time_frame>
    <description>the error in placing the unaffected foot at a location previously defined by the affected foot</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Spatial Perception</condition>
  <condition>Stroke</condition>
  <condition>Virtual Reality</condition>
  <condition>Exercise Training</condition>
  <condition>Exproprioception</condition>
  <arm_group>
    <arm_group_label>Non-visual exproprioception training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The training requires the participant to place the foot at a target without visual cues of the foot in virtual environment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Visual exproprioception group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The training requires the participant to place the foot at a target with visual cues of the foot in virtual environment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Virtual reality foot placement training</intervention_name>
    <description>The training is conducted in sitting and standing, and involves both the affected and unaffected foot placement. In the total immersive virtual environment, a target will be presented and the participants are required to move one foot to the target. The location of the moving foot is not seen by the participant in this training.</description>
    <arm_group_label>Non-visual exproprioception training</arm_group_label>
    <arm_group_label>Visual exproprioception group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  first time unilateral stroke and onset over 6 months&#xD;
&#xD;
          -  able to independent walking with or without aids over 10 meters&#xD;
&#xD;
          -  Mini-Mental State Examination (MMSE) score above 24&#xD;
&#xD;
          -  orientation intake, able to identify right and left&#xD;
&#xD;
          -  normal or corrected-to-normal vision, able to see the 2 cm diameter circle on the&#xD;
             floor while standing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  gait nearly normal&#xD;
&#xD;
          -  had other neurological and musculoskeletal disease which can affect walking ability&#xD;
&#xD;
          -  hemineglect&#xD;
&#xD;
          -  use virtual reality device will severely discomfort, such as headaches, blurred&#xD;
             vision, vertigo or vomiting&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sang-I Lin, PhD</last_name>
    <phone>+88662353535</phone>
    <phone_ext>5020</phone_ext>
    <email>lin31@mail.ncku.edu.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Cheng Kung University</name>
      <address>
        <city>Tainan</city>
        <zip>701</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sang-I Lin, PhD</last_name>
      <phone>+886-6-235-3535</phone>
      <phone_ext>5020</phone_ext>
      <email>lin31@mail.ncku.edu.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>September 3, 2021</last_update_submitted>
  <last_update_submitted_qc>September 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Cheng Kung University</investigator_affiliation>
    <investigator_full_name>Sang-I Lin</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04436237
org study id: A-ER-108-183
nct id: NCT04436237
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine if a virtual reality training of foot placement
      with or without visual cues about the location of the foot in the environment would improve
      locomotion-related function in persons in the chronic stage of stroke. Participants were
      randomly assigned to receive twice per week, for a total of 2 weeks' training with visual
      cues (control group) or without (experimental group). It was hypothesized that the
      experimental group would be able to place the foot closer to the target when stepping and
      have more symmetrical gait. So far, 22 stroke patients completed the experiment. Preliminary
      results support the hypothesis. This project is still ongoing.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: foot placement accuracy (cm)
time frame: 2 weeks
description: The distance between the foot and the target in various stepping tasks
measure: gait symmetry
time frame: 2 weeks
description: ratio of the two leg step lengths
measure: exproprioception (cm)
time frame: 2 weeks
description: the error in placing the unaffected foot at a location previously defined by the affected foot
arm group label: Non-visual exproprioception training
arm group type: Experimental
description: The training requires the participant to place the foot at a target without visual cues of the foot in virtual environment.
arm group label: Visual exproprioception group
arm group type: Active Comparator
description: The training requires the participant to place the foot at a target with visual cues of the foot in virtual environment.
intervention type: Other
intervention name: Virtual reality foot placement training
description: The training is conducted in sitting and standing, and involves both the affected and unaffected foot placement. In the total immersive virtual environment, a target will be presented and the participants are required to move one foot to the target. The location of the moving foot is not seen by the participant in this training.
arm group label: Non-visual exproprioception training
arm group label: Visual exproprioception group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Sang-I Lin, PhD
phone: +88662353535
phone ext: 5020
email: lin31@mail.ncku.edu.tw
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: National Cheng Kung University
investigator full name: Sang-I Lin
investigator title: Professor
mesh term: Stroke
sharing ipd: Undecided