<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/NCT02251470</url>
  </required_header>
  <id_info>
    <org_study_id>IRM_01</org_study_id>
    <nct_id>NCT02251470</nct_id>
  </id_info>
  <brief_title>Home-based Balance Training Using Wii Fit After Stroke: A Feasibility Study</brief_title>
  <acronym>WiiMobil</acronym>
  <official_title>The Application of a Video-game System (Nintendo Wii®) as an Independent Exercise Program to Improve Mobility After Stroke - a Randomized Phase II Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Martin-Luther-Universität Halle-Wittenberg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Martin-Luther-Universität Halle-Wittenberg</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      BACKGROUND: Virtual gaming systems offer new possibilities for home-based exercises (HBE) in&#xD;
      rehabilitation. Pilot studies with stroke patients indicate that the application of Nintendo&#xD;
      Wii® (WII) is practicable and can improve balance under clinical conditions. However, larger&#xD;
      trials are necessary to verify these positive effects after discharge from the hospital.&#xD;
&#xD;
      AIM: This study aims to prepare and optimize a phase III trial which compares the effects of&#xD;
      two HBE programs for stroke patients.&#xD;
&#xD;
      METHODS: A pilot study with randomized control design and repeated measures over three-months&#xD;
      will be conducted. Twenty elderly stroke patients will be randomly allocated to an&#xD;
      experimental group (EG) and a control group (CG). All participants will receive an&#xD;
      introduction to a HBE program by an individual mentoring over 6 weeks. During the following 6&#xD;
      weeks the participants perform the HBE on their own. The EG will perform a balance exercise&#xD;
      program using the WII, the CG will perform a balance exercise program without technical&#xD;
      support.&#xD;
&#xD;
      Recruiting potential, the participants' acceptance of the intervention and economic aspects&#xD;
      will be examined. Additionally, basic information about sensitivity of change and potential&#xD;
      effect sizes regarding the proposed instruments to measure mobility are expected.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility</measure>
    <time_frame>12-weeks</time_frame>
    <description>Recruiting potential, the participants' acceptance/satisfaction of the intervention and economic aspects</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mobility</measure>
    <time_frame>Baseline - after 6 weeks - after 12 weeks</time_frame>
    <description>Berg Balance Scale, Dynamic Gait Index, Timed Up and Go (TUG) Test, Activities-Specific Balance Confidence Scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>HBE Wii (EG)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive an introduction of using the Nintendo Wii by an individual mentoring for over 6 weeks (a total of 6 sessions á 60 minutes). During the following 6 weeks the participants perform the balance exercise program (wii-fit balances games) at home (instruction: min. 3 times a week for each 30 minutes).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HBE Control (CG)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants receive an introduction for conventional/traditional balance exercise by an individual mentoring for over 6 weeks (a total of 6 sessions á 60 minutes). During the following 6 weeks the participants perform the balance exercise program (exercises in standing and walking) at home (instruction: min. 3 times a week for each 30 minutes).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>HBE Wii (EG)</intervention_name>
    <description>Wii-Fit Balance games (Soccer Heading, Ski Slalom, Table Tilt, Balance Bubble etc.)</description>
    <arm_group_label>HBE Wii (EG)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>HBE Control (CG)</intervention_name>
    <description>Simple balance exercises with own body weight (Single limb stance, stepping, side sways etc.)</description>
    <arm_group_label>HBE Control (CG)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  cerebral infarction&#xD;
&#xD;
          -  place of residence: Halle (Saale) and immediate surroundings&#xD;
&#xD;
          -  television in household&#xD;
&#xD;
          -  independent ambulatory (functional ambulation classification &gt; 3)&#xD;
&#xD;
          -  self-selected walking speed &gt; 0,4 m/s&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Strong visual impairment despite visual aid&#xD;
&#xD;
          -  Deafness / verbal communication is not possible&#xD;
&#xD;
          -  distinct mobility limitations due to comorbidity&#xD;
&#xD;
          -  Body weight &gt;120kg&#xD;
&#xD;
          -  Epilepsy&#xD;
&#xD;
          -  Cardiac pacemaker&#xD;
&#xD;
          -  Acute psychiatric, disease/dementia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wilfried Mau, Prof. Dr.</last_name>
    <role>Study Director</role>
    <affiliation>Institute of Rehabilitation Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>André Golla</last_name>
    <role>Study Chair</role>
    <affiliation>Institute of Rehabilitation Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital &quot;BG-Kliniken Bergmannstrost&quot;</name>
      <address>
        <city>Halle</city>
        <state>Saxony-Anhalt</state>
        <zip>D-06112</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Halle</name>
      <address>
        <city>Halle</city>
        <state>Saxony-Anhalt</state>
        <zip>D-06120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <last_update_submitted>December 1, 2015</last_update_submitted>
  <last_update_submitted_qc>December 1, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Martin-Luther-Universität Halle-Wittenberg</investigator_affiliation>
    <investigator_full_name>André Golla</investigator_full_name>
    <investigator_title>André Golla</investigator_title>
  </responsible_party>
  <keyword>stroke</keyword>
  <keyword>balance</keyword>
  <keyword>exer-gaming</keyword>
  <keyword>home-based exercises</keyword>
  <keyword>Wii</keyword>
  <keyword>postural balance</keyword>
  <keyword>Nintendo</keyword>
  <keyword>balance board</keyword>
  <keyword>Wii-Fit</keyword>
  <keyword>home</keyword>
  <keyword>feasibility</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <!-- 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/NCT02251470
org study id: IRM_01
nct id: NCT02251470
lead sponsor: 
has dmc: No
BACKGROUND: Virtual gaming systems offer new possibilities for home-based exercises (HBE) in
      rehabilitation. Pilot studies with stroke patients indicate that the application of Nintendo
      Wii® (WII) is practicable and can improve balance under clinical conditions. However, larger
      trials are necessary to verify these positive effects after discharge from the hospital.

      AIM: This study aims to prepare and optimize a phase III trial which compares the effects of
      two HBE programs for stroke patients.

      METHODS: A pilot study with randomized control design and repeated measures over three-months
      will be conducted. Twenty elderly stroke patients will be randomly allocated to an
      experimental group (EG) and a control group (CG). All participants will receive an
      introduction to a HBE program by an individual mentoring over 6 weeks. During the following 6
      weeks the participants perform the HBE on their own. The EG will perform a balance exercise
      program using the WII, the CG will perform a balance exercise program without technical
      support.

      Recruiting potential, the participants' acceptance of the intervention and economic aspects
      will be examined. Additionally, basic information about sensitivity of change and potential
      effect sizes regarding the proposed instruments to measure mobility are expected.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Feasibility
time frame: 12-weeks
description: Recruiting potential, the participants' acceptance/satisfaction of the intervention and economic aspects
measure: Mobility
time frame: Baseline - after 6 weeks - after 12 weeks
description: Berg Balance Scale, Dynamic Gait Index, Timed Up and Go (TUG) Test, Activities-Specific Balance Confidence Scale
arm group label: HBE Wii (EG)
arm group type: Experimental
description: Participants receive an introduction of using the Nintendo Wii by an individual mentoring for over 6 weeks (a total of 6 sessions á 60 minutes). During the following 6 weeks the participants perform the balance exercise program (wii-fit balances games) at home (instruction: min. 3 times a week for each 30 minutes).
arm group label: HBE Control (CG)
arm group type: Active Comparator
description: Participants receive an introduction for conventional/traditional balance exercise by an individual mentoring for over 6 weeks (a total of 6 sessions á 60 minutes). During the following 6 weeks the participants perform the balance exercise program (exercises in standing and walking) at home (instruction: min. 3 times a week for each 30 minutes).
intervention type: Other
intervention name: HBE Wii (EG)
description: Wii-Fit Balance games (Soccer Heading, Ski Slalom, Table Tilt, Balance Bubble etc.)
arm group label: HBE Wii (EG)
intervention type: Other
intervention name: HBE Control (CG)
description: Simple balance exercises with own body weight (Single limb stance, stepping, side sways etc.)
arm group label: HBE Control (CG)
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Wilfried Mau, Prof. Dr.
role: Study Director
affiliation: Institute of Rehabilitation Medicine
last name: André Golla
role: Study Chair
affiliation: Institute of Rehabilitation Medicine
facility: 
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Martin-Luther-Universität Halle-Wittenberg
investigator full name: André Golla
investigator title: André Golla
mesh term: Stroke