<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/NCT03282968</url>
  </required_header>
  <id_info>
    <org_study_id>URIS201704</org_study_id>
    <nct_id>NCT03282968</nct_id>
  </id_info>
  <brief_title>Balance Training After Stroke With REWIRE</brief_title>
  <acronym>REWIRESI</acronym>
  <official_title>Balance Training With the Rehabilitative Wayout In Responsive Home Environments (REWIRE) System in Patients After Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Rehabilitation Institute, Republic of Slovenia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jozef Stefan Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Rehabilitation Institute, Republic of Slovenia</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 study will include 20 patients after troke, randomly assigned to the experimental and&#xD;
      control group (10 each). In both groups, the program with last for five days; walking and&#xD;
      balance will be assessed before and after the program. Both groups will receive regular&#xD;
      neurophysiotherapy; in addition, the experimental group will exercise each day by playing&#xD;
      REWIRE games, while the control group will perform standing balance exercises.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Detailed inclusion and exclusion criteria are specified in the appropriate section. Both&#xD;
      groups will perform the additional exercises for 15 minutes daily. In addition to the outcome&#xD;
      measurement, informal feedback will be obtained from the patients and the therapists on the&#xD;
      feasibility of the REWIRE system.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 3, 2017</start_date>
  <completion_date type="Actual">March 31, 2018</completion_date>
  <primary_completion_date type="Actual">July 1, 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>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in walking speed</measure>
    <time_frame>Assessment one day before and one day after the program</time_frame>
    <description>Assessed using 10 Meter Walking Test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in dynamic balance</measure>
    <time_frame>Assessment one day before and one day after the program</time_frame>
    <description>Assessed using Four Step Square Test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in mobility</measure>
    <time_frame>Assessment one day before and one day after the program</time_frame>
    <description>Assessed using Timed Up and Go test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in static standing balance</measure>
    <time_frame>Assessment one day before and one day after the program</time_frame>
    <description>Assessed using Romberg test</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Regular neurophysiotherapy plus REWIRE exercises</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Regular neurophysiotherapy plus standing balance exercises</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>REWIRE</intervention_name>
    <description>First, the patient will play the Fruit Catcher (weight transfer) game on the 3rd level for 3 minutes, followed by 3 minutes of rest. Next, the patient will play the Horse Runner (squats) on the 3rd level for 3 minutes, followed by 3 minutes of rest. In the end, the patient will play the Animal Hurdler (standing on one leg) on the 3rd level for 3 minutes. During the games, the patient will be standing on the Wii Balance Board, holding to a firm support if necessary. During the rest periods, the patients will be sitting. A physiotherapist will be present throughout the exercise for safety and help if requested.</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Balance exercises</intervention_name>
    <description>The patient will first practice balance transfer for 3 minutes (standing by a ladder, holding position on each leg for 3 seconds), followed by 3 minutes of rest. Next, the patient will be performing squats for 3 minutes, followed by 3 minutes of rest. In the end, the patient will practice alternatively lifting lower limbs (like stepping on a footstool) for 3 minutes. During the rest periods, the patients will be sitting. A physiotherapist will be present throughout the exercise for safety and help if requested.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  first stroke&#xD;
&#xD;
          -  first admission to inpatient rehabilitation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  less than 25 points scored on the Mini-Mental State Examination&#xD;
&#xD;
          -  inability to walk independently&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Imre Cikajlo, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Rehabilitation Institute, Rehabilitation of Slovenia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Rehabilitation Institute, Republic of Slovenia</name>
      <address>
        <city>Ljubljana</city>
        <zip>1000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Slovenia</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>April 9, 2018</last_update_submitted>
  <last_update_submitted_qc>April 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>exergaming</keyword>
  <keyword>physiotherapy</keyword>
  <keyword>balance</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>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/NCT03282968
org study id: URIS201704
nct id: NCT03282968
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study will include 20 patients after troke, randomly assigned to the experimental and
      control group (10 each). In both groups, the program with last for five days; walking and
      balance will be assessed before and after the program. Both groups will receive regular
      neurophysiotherapy; in addition, the experimental group will exercise each day by playing
      REWIRE games, while the control group will perform standing balance exercises.
Detailed inclusion and exclusion criteria are specified in the appropriate section. Both
      groups will perform the additional exercises for 15 minutes daily. In addition to the outcome
      measurement, informal feedback will be obtained from the patients and the therapists on the
      feasibility of the REWIRE system.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Change in walking speed
time frame: Assessment one day before and one day after the program
description: Assessed using 10 Meter Walking Test
measure: Change in dynamic balance
time frame: Assessment one day before and one day after the program
description: Assessed using Four Step Square Test
measure: Change in mobility
time frame: Assessment one day before and one day after the program
description: Assessed using Timed Up and Go test
measure: Change in static standing balance
time frame: Assessment one day before and one day after the program
description: Assessed using Romberg test
arm group label: Experimental
arm group type: Experimental
description: Regular neurophysiotherapy plus REWIRE exercises
arm group label: Control
arm group type: Active Comparator
description: Regular neurophysiotherapy plus standing balance exercises
intervention type: Device
intervention name: REWIRE
description: First, the patient will play the Fruit Catcher (weight transfer) game on the 3rd level for 3 minutes, followed by 3 minutes of rest. Next, the patient will play the Horse Runner (squats) on the 3rd level for 3 minutes, followed by 3 minutes of rest. In the end, the patient will play the Animal Hurdler (standing on one leg) on the 3rd level for 3 minutes. During the games, the patient will be standing on the Wii Balance Board, holding to a firm support if necessary. During the rest periods, the patients will be sitting. A physiotherapist will be present throughout the exercise for safety and help if requested.
arm group label: Experimental
intervention type: Other
intervention name: Balance exercises
description: The patient will first practice balance transfer for 3 minutes (standing by a ladder, holding position on each leg for 3 seconds), followed by 3 minutes of rest. Next, the patient will be performing squats for 3 minutes, followed by 3 minutes of rest. In the end, the patient will practice alternatively lifting lower limbs (like stepping on a footstool) for 3 minutes. During the rest periods, the patients will be sitting. A physiotherapist will be present throughout the exercise for safety and help if requested.
arm group label: Control
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Imre Cikajlo, PhD
role: Principal Investigator
affiliation: University Rehabilitation Institute, Rehabilitation of Slovenia
facility: 
country: Slovenia
responsible party type: Sponsor
mesh term: Stroke
sharing ipd: Undecided