<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/NCT03261713</url>
  </required_header>
  <id_info>
    <org_study_id>BAMO IF2017</org_study_id>
    <nct_id>NCT03261713</nct_id>
  </id_info>
  <brief_title>Home-based Virtual Reality Training After Stroke</brief_title>
  <official_title>Home-based Virtual Reality Training After Discharge From Hospital-based Stroke Rehabilitation: A Parallel Randomised Feasibility Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bruyere Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bruyere Academic Medical Organization</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bruyere Research Institute</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>
      Virtual reality (VR) training (VRT) uses computer software to track a user's movements and&#xD;
      allow them to interact with a game presented on a TV. It is fun and engaging and may&#xD;
      encourage the user to do more exercise. VRT is increasingly being used for rehabilitation&#xD;
      after stroke. Patients often require ongoing therapy post-discharge from inpatient&#xD;
      rehabilitation. Outpatient therapy may be unavailable due to waiting lists, transportation&#xD;
      issues, distance etc.; therefore, home-based VRT may be the answer. Our objectives are to&#xD;
      determine: 1) the feasibility of home-based VRT for stroke patients after discharge from&#xD;
      hospital-based rehabilitation, and 2) the feasibility of a battery of outcome measures. Forty&#xD;
      stroke rehabilitation patients will be recruited over 18 months and randomize them to&#xD;
      experimental or control groups. VRT participants will be introduced to VRT at the hospital&#xD;
      and a VRT system will be set up in their homes shortly after discharge. Control participants&#xD;
      will be provided with games and apps on an iPad focusing on cognition and fine motor skills.&#xD;
      Participants will be instructed to perform 30 minutes of VRT 5 days a week for 6 weeks.&#xD;
      Training will be monitored remotely. Both groups will receive weekly phone calls to review&#xD;
      their home activity and answer questions. Measurements will be made of standing balance and&#xD;
      general function before and after training, and feasibility (compliance, enjoyment, safety).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stroke causes approximately 15 300 hospital admissions per year in Ontario and 50% of&#xD;
      individuals who have had a stroke are left with moderate to severe impairment. Because of the&#xD;
      severity of their condition, these individuals often cannot stand and have poor sitting and&#xD;
      standing balance. Most patients who are discharged from inpatient stroke rehabilitation are&#xD;
      8-10 weeks post-stroke and have not completely recovered. Their brains are still in a period&#xD;
      of enhanced neuroplasticity, during which great functional change can be made; Therapy&#xD;
      outcomes are dose-dependent; intensive, high-repetition, task-oriented and task-specific&#xD;
      therapies are most effective. Therefore, for the greatest recovery possible, these patients&#xD;
      require ongoing therapy. Most are offered this on an outpatient basis. However, for many&#xD;
      reasons (transportation difficulties, distance from downtown, weather etc.), not all eligible&#xD;
      patients are able to attend outpatient therapy. Also, there is a waiting list and a limited&#xD;
      number of outpatient therapy sessions are offered to each patient.&#xD;
&#xD;
      Virtual reality training (VRT) uses computer software to track the user's movements and allow&#xD;
      him or her to interact with a game or activity presented on a TV screen. It is convenient,&#xD;
      timely, and enjoyable, and may be done for an unlimited period post-stroke. VRT has been&#xD;
      shown to benefit upper extremity function, standing balance, gait and overall function.&#xD;
      Home-based VRT offers a promising addition or alternative to existing rehabilitation programs&#xD;
      and home exercise programs that could make a significant difference in the lives of stroke&#xD;
      survivors. A few pilot studies have investigated the use of home-based VRT for standing&#xD;
      balance and upper extremity recovery after stroke and shown the feasibility of these systems&#xD;
      for ongoing rehabilitation in the home. The investigators wish to expand on these studies by&#xD;
      using a new VR system, made by Jintronix Inc. (Montreal, QC). This system was initially&#xD;
      developed for stroke rehabilitation and has also been used extensively with healthy and frail&#xD;
      elderly individuals. The Jintronix system is marketed for institutional and home use and has&#xD;
      a simple-to-use interface but its home use has not yet been fully evaluated. The games are&#xD;
      designed to incorporate motor learning principles such as multiple forms of feedback and&#xD;
      task-specific practice that can be progressed to maintain an appropriate level of challenge.&#xD;
      The purpose of this study is to investigate the feasibility, acceptance and safety of this&#xD;
      new, simple-to-use VRT system used in the home, combined with substantial remote support for&#xD;
      the user.&#xD;
&#xD;
      The primary objectives assessed the feasibility of using VRT in the home by patients&#xD;
      post-stroke, using quantitative and qualitative methods. Specific objectives were:&#xD;
&#xD;
        1. To estimate the recruitment rate of participants into the study;&#xD;
&#xD;
        2. To assess the ability and compliance of the participants with respect to the components&#xD;
           of the research protocol (ability to learn VRT through the training program; ability to&#xD;
           comply with the exercise protocol; participant retention);&#xD;
&#xD;
        3. To determine the safety of home-based VRT (presence of minor and major adverse events);&#xD;
&#xD;
        4. To assess the ability of stroke survivors and their study partners to use VRT technology&#xD;
           in the home (i.e. technical difficulties, difficulty learning the games);&#xD;
&#xD;
        5. To assess the acceptability of the VRT intervention (enjoyment; perceived efficacy)&#xD;
&#xD;
        6. To estimate the cost for a future definitive randomised control trial (RCT) on in-home&#xD;
           VRT.&#xD;
&#xD;
      The secondary objectives assessed the feasibility of the outcome measures, using quantitative&#xD;
      and qualitative methods. Specific objectives were:&#xD;
&#xD;
        1. To assess the feasibility and acceptance of a battery of outcome measures, including&#xD;
           physical assessments, questionnaires, an interview and a log book;&#xD;
&#xD;
        2. To assess the potential that home-based VRT might maintain or improve physical outcomes&#xD;
           (standing balance, gait, general function) and community integration after discharge&#xD;
           from hospital-based stroke rehabilitation, compared to those who only participate in&#xD;
           their regular activities of daily living.&#xD;
&#xD;
        3. To determine the sample size required for a future definitive RCT on in-home VRT.&#xD;
&#xD;
      Procedures Participants in both the experimental and control groups (and their caregivers for&#xD;
      those in the experimental group only) attend a total of 4 sessions at Élisabeth Bruyère&#xD;
      Hospital. The first three sessions occur in the week or two before discharge from inpatient&#xD;
      or outpatient rehabilitation. At sessions 1 and 2, each lasting approximately 60 minutes,&#xD;
      participants and their study partners in the experimental group are trained on how to use the&#xD;
      VRT system and play the games. They are also instructed what to do if something went wrong&#xD;
      (for example, if the participant falls or the equipment does not work). Participants are&#xD;
      given a simple manual on VRT. Participants in the control group also attend two training&#xD;
      sessions, each lasting approximately 45 minutes, on how to use the tablet and use the apps.&#xD;
      Outcome measures are performed at sessions 3 (before discharge) and 4 (after 6 weeks of VRT);&#xD;
      each session takes approximately 1½ hours.&#xD;
&#xD;
      After discharge from inpatient or outpatient rehabilitation, the research physical therapist&#xD;
      (PT) installs the VRT system into the participant's home and reviews the games, safety&#xD;
      considerations and follow-up procedures with the participant and their study partner. The&#xD;
      supervising caregiver must be in the home of the participant while he or she is doing VRT.&#xD;
      The PT monitors the game and parameter selections along with time spent on VRT at least once&#xD;
      a week using the remote access feature of the VRT system, and modifies the games if&#xD;
      necessary.&#xD;
&#xD;
      Participants in both groups are instructed to perform their exercise plan 5 times a week for&#xD;
      6 weeks for 30 minutes at each session. This amount of additional training (15 hours) has&#xD;
      been shown to produce a significant improvement in activities of daily living post-stroke.&#xD;
      All participants are contacted by telephone twice a week for the first week and at least once&#xD;
      a week for the following 5 weeks to offer encouragement, suggest modifications to the games&#xD;
      and identify any safety issues or technical problems. Participants are also invited to&#xD;
      contact the research PT as needed. Participants in both groups are encouraged to do as many&#xD;
      activities of daily living (ADLs) and instrumental ADLs (IADLs) as they wish, including&#xD;
      walking, participation in exercise groups and therapy. They are not prevented from undergoing&#xD;
      further rehabilitation while enrolled in the feasibility study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 16, 2017</start_date>
  <completion_date type="Actual">November 28, 2018</completion_date>
  <primary_completion_date type="Actual">November 28, 2018</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>
    <intervention_model_description>A prospective, single-site, single-blinded, parallel-group (1:1 ratio) randomized feasibility trial on the use of VRT for ongoing stroke rehabilitation after discharge from inpatient or outpatient stroke rehabilitation.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The outcomes assessor does not know the participant's intervention group allocation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Recruitment rate</measure>
    <time_frame>18 months</time_frame>
    <description>number of participants recruited over 18 months of participant intake relative to the number who met study criteria and number who were approached</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quantitative assessment of ability and compliance to research protocol</measure>
    <time_frame>18 months</time_frame>
    <description>assessed by monitoring the use and progression of the VRT program</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Qualitative assessment of ability and compliance to research protocol</measure>
    <time_frame>18 months</time_frame>
    <description>assessed through comments made by the participant and study partner</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse events (incidence &amp; type) due to home-based VRT intervention</measure>
    <time_frame>18 months</time_frame>
    <description>presence of adverse effects (minor and severe) recorded from telephone conversations and through log book</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ability to use VRT in the home</measure>
    <time_frame>18 months</time_frame>
    <description>assessed through comments made by the participant and study partner</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quantitative assessment of acceptability of VRT intervention</measure>
    <time_frame>18 months</time_frame>
    <description>assessed with the Physical Activity Enjoyment Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Qualitative assessment of acceptability of VRT intervention</measure>
    <time_frame>18 months</time_frame>
    <description>assessed through comments made by the participant and study partner</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Estimate cost for a future definitive RCT</measure>
    <time_frame>18 months</time_frame>
    <description>calculate costs of all components of this study</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ability of participants to perform Berg Balance Scale without quitting due to fatigue or frustration</measure>
    <time_frame>18 months</time_frame>
    <description>1) Berg Balance Scale (BBS, Berg et al.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ability of participants to perform Timed Up &amp; Go (original version) without quitting due to fatigue or frustration</measure>
    <time_frame>18 months</time_frame>
    <description>Timed Up And Go (TUG, original version, Campbell et al.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ability of participants to perform Timed Up &amp; Go (manual version) without quitting due to fatigue or frustration</measure>
    <time_frame>18 months</time_frame>
    <description>Timed Up And Go (TUG, manual version, Hofheinz &amp; Schusterschitz)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ability of participants to perform Timed Up &amp; Go (cognitive version) without quitting due to fatigue or frustration</measure>
    <time_frame>18 months</time_frame>
    <description>Timed Up And Go (TUG, cognitive version, Lundin-Olsson et al.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ability of participants to perform Five Times Sit-to-Stand without quitting due to fatigue or frustration</measure>
    <time_frame>18 months</time_frame>
    <description>Five Times Sit-to-Stand Test (FTSST, Bohannon et al.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ability of participants to perform Community Balance &amp; Mobility Scale without quitting due to fatigue or frustration</measure>
    <time_frame>18 months</time_frame>
    <description>Community Balance &amp; Mobility Scale (CBM, Howe et al.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ability of participants to perform quantitative analysis of quiet stance in standing without quitting due to fatigue or frustration</measure>
    <time_frame>18 months</time_frame>
    <description>movement of the centre of pressure on a force plate during quiet stance in standing (Preuss &amp; Popovic)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ability of participants to perform quantitative analysis of limits of stability in standing without quitting due to fatigue or frustration</measure>
    <time_frame>18 months</time_frame>
    <description>quantitative assessment of the limits of stability in standing done on a force plate (Preuss &amp; Popovic)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potential for home-based VRT to maintain or improve performance on the Berg Balance Scale</measure>
    <time_frame>18 months</time_frame>
    <description>Berg Balance Scale (BBS, Berg et al.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potential for home-based VRT to maintain or improve performance on the Timed Up And Go scale (original version)</measure>
    <time_frame>18 months</time_frame>
    <description>Timed Up And Go (original version, Campbell et al.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potential for home-based VRT to maintain or improve performance on the Timed Up And Go scale (manual version)</measure>
    <time_frame>18 months</time_frame>
    <description>Timed Up And Go (manual version, Hofheinz &amp; Schusterschitz)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potential for home-based VRT to maintain or improve performance on the Timed Up And Go scale (cognitive version)</measure>
    <time_frame>18 months</time_frame>
    <description>Timed Up And Go (cognitive version, Lundin-Olsson et al.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potential for home-based VRT to maintain or improve performance on the Five Times Sit-To-Stand Test</measure>
    <time_frame>18 months</time_frame>
    <description>Five Times Sit-To-Stand Test (FTSST, Bohannon et al.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potential for home-based VRT to maintain or improve performance on the Community Balance and Mobility Scale</measure>
    <time_frame>18 months</time_frame>
    <description>Community Balance and Mobility Scale (CBM, Howe et al.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potential for home-based VRT to maintain or improve performance on quantitative analyses of quiet stance and limits of stability in standing</measure>
    <time_frame>18 months</time_frame>
    <description>quantitative analyses of quiet stance and limits of stability in standing (Preuss &amp; Popovic)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potential for home-based VRT to maintain or improve performance on the Stroke Impact Scale</measure>
    <time_frame>18 months</time_frame>
    <description>Stroke Impact Scale (SIS, Duncan et al.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potential for home-based VRT to maintain or improve performance on the Reintegration to Normal Living Index</measure>
    <time_frame>18 months</time_frame>
    <description>Reintegration to Normal Living Index (RNLI, Spitzer et al).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determine a sample size for a definitive RCT on home-based VRT</measure>
    <time_frame>18 months</time_frame>
    <description>Results of the Berg Balance Scale (BBS, Berg et al.) to calculate sample size.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Virtual Reality</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Virtual reality training designed to train standing balance, reaching, stepping, gentle strengthening and aerobic conditioning.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>iPad apps designed to train memory, cognition, visual tracking and fine motor skills.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Virtual reality</intervention_name>
    <description>Virtual reality training is provided using Jintronix Rehabilitation software. A Kinect camera captures the movements of the participant using infrared technology and allows them to control an avatar, which interacts with an activity. Several games and activities are available to train standing balance (ex. slalom skiing), reaching (ex. planting seeds/harvesting tomatoes), stepping (ex. whack-a-mole), gentle strengthening (ex. knee extensions) and aerobic exercises (ex. marching on the spot). Game and activity difficulty can be increased by requiring more repetitions, or greater speed, distance and/or accuracy. Specific games and activities, and their parameters are customized for each participant. The exercise plan is performed 5 times a week for 6 weeks for 30 minutes at each session.</description>
    <arm_group_label>Virtual Reality</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Participants in the control group are provided with an iPad which contains a selection of apps suited for memory (ex. memory card game), cognition (Sudoku, cross-word), visual tracking (word search) and fine motor skills (ex. writing, whack-a-mole). Participants are instructed to perform their exercise plan 5 times a week for 6 weeks for 30 minutes at each session.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. have had a stroke (ischemic or hemorrhagic) resulting in physical impairment;&#xD;
&#xD;
          2. have enough preserved cognitive ability to learn VRT&#xD;
&#xD;
          3. are receiving inpatient or outpatient stroke rehabilitation services;&#xD;
&#xD;
          4. are able to stand independently for at least 2 minutes&#xD;
&#xD;
          5. have a study partner who could attend 2 training sessions with the participant and was&#xD;
             able to be in the home with the participant while doing VRT;&#xD;
&#xD;
          6. can read, speak and understand English;&#xD;
&#xD;
          7. live within 50 km of Élisabeth Bruyère Hospital;&#xD;
&#xD;
          8. are able and willing to attend 4 appointments at Élisabeth Bruyère Hospital (2 for&#xD;
             assessment; 2 for training);&#xD;
&#xD;
          9. will not be travelling away from home for more than 2 days a week for the duration of&#xD;
             the study;&#xD;
&#xD;
         10. have enough space in their home to do VRT safely.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. have an unstable medical condition, seizures or vertigo,&#xD;
&#xD;
          2. are unable to perform mild to moderate exercise safely.&#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>Hillel Finestone, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bruyere Continuing Care</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Elisabeth Bruyère Hospital</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1N 5C8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>June 13, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>July 23, 2019</last_update_submitted>
  <last_update_submitted_qc>July 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>rehabilitation</keyword>
  <keyword>telerehabilitation</keyword>
  <keyword>feasibility studies</keyword>
  <keyword>virtual reality</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>
  <!-- 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/NCT03261713
org study id: BAMO IF2017
nct id: NCT03261713
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Virtual reality (VR) training (VRT) uses computer software to track a user's movements and
      allow them to interact with a game presented on a TV. It is fun and engaging and may
      encourage the user to do more exercise. VRT is increasingly being used for rehabilitation
      after stroke. Patients often require ongoing therapy post-discharge from inpatient
      rehabilitation. Outpatient therapy may be unavailable due to waiting lists, transportation
      issues, distance etc.; therefore, home-based VRT may be the answer. Our objectives are to
      determine: 1) the feasibility of home-based VRT for stroke patients after discharge from
      hospital-based rehabilitation, and 2) the feasibility of a battery of outcome measures. Forty
      stroke rehabilitation patients will be recruited over 18 months and randomize them to
      experimental or control groups. VRT participants will be introduced to VRT at the hospital
      and a VRT system will be set up in their homes shortly after discharge. Control participants
      will be provided with games and apps on an iPad focusing on cognition and fine motor skills.
      Participants will be instructed to perform 30 minutes of VRT 5 days a week for 6 weeks.
      Training will be monitored remotely. Both groups will receive weekly phone calls to review
      their home activity and answer questions. Measurements will be made of standing balance and
      general function before and after training, and feasibility (compliance, enjoyment, safety).
Stroke causes approximately 15 300 hospital admissions per year in Ontario and 50% of
      individuals who have had a stroke are left with moderate to severe impairment. Because of the
      severity of their condition, these individuals often cannot stand and have poor sitting and
      standing balance. Most patients who are discharged from inpatient stroke rehabilitation are
      8-10 weeks post-stroke and have not completely recovered. Their brains are still in a period
      of enhanced neuroplasticity, during which great functional change can be made; Therapy
      outcomes are dose-dependent; intensive, high-repetition, task-oriented and task-specific
      therapies are most effective. Therefore, for the greatest recovery possible, these patients
      require ongoing therapy. Most are offered this on an outpatient basis. However, for many
      reasons (transportation difficulties, distance from downtown, weather etc.), not all eligible
      patients are able to attend outpatient therapy. Also, there is a waiting list and a limited
      number of outpatient therapy sessions are offered to each patient.

      Virtual reality training (VRT) uses computer software to track the user's movements and allow
      him or her to interact with a game or activity presented on a TV screen. It is convenient,
      timely, and enjoyable, and may be done for an unlimited period post-stroke. VRT has been
      shown to benefit upper extremity function, standing balance, gait and overall function.
      Home-based VRT offers a promising addition or alternative to existing rehabilitation programs
      and home exercise programs that could make a significant difference in the lives of stroke
      survivors. A few pilot studies have investigated the use of home-based VRT for standing
      balance and upper extremity recovery after stroke and shown the feasibility of these systems
      for ongoing rehabilitation in the home. The investigators wish to expand on these studies by
      using a new VR system, made by Jintronix Inc. (Montreal, QC). This system was initially
      developed for stroke rehabilitation and has also been used extensively with healthy and frail
      elderly individuals. The Jintronix system is marketed for institutional and home use and has
      a simple-to-use interface but its home use has not yet been fully evaluated. The games are
      designed to incorporate motor learning principles such as multiple forms of feedback and
      task-specific practice that can be progressed to maintain an appropriate level of challenge.
      The purpose of this study is to investigate the feasibility, acceptance and safety of this
      new, simple-to-use VRT system used in the home, combined with substantial remote support for
      the user.

      The primary objectives assessed the feasibility of using VRT in the home by patients
      post-stroke, using quantitative and qualitative methods. Specific objectives were:

        1. To estimate the recruitment rate of participants into the study;

        2. To assess the ability and compliance of the participants with respect to the components
           of the research protocol (ability to learn VRT through the training program; ability to
           comply with the exercise protocol; participant retention);

        3. To determine the safety of home-based VRT (presence of minor and major adverse events);

        4. To assess the ability of stroke survivors and their study partners to use VRT technology
           in the home (i.e. technical difficulties, difficulty learning the games);

        5. To assess the acceptability of the VRT intervention (enjoyment; perceived efficacy)

        6. To estimate the cost for a future definitive randomised control trial (RCT) on in-home
           VRT.

      The secondary objectives assessed the feasibility of the outcome measures, using quantitative
      and qualitative methods. Specific objectives were:

        1. To assess the feasibility and acceptance of a battery of outcome measures, including
           physical assessments, questionnaires, an interview and a log book;

        2. To assess the potential that home-based VRT might maintain or improve physical outcomes
           (standing balance, gait, general function) and community integration after discharge
           from hospital-based stroke rehabilitation, compared to those who only participate in
           their regular activities of daily living.

        3. To determine the sample size required for a future definitive RCT on in-home VRT.

      Procedures Participants in both the experimental and control groups (and their caregivers for
      those in the experimental group only) attend a total of 4 sessions at Élisabeth Bruyère
      Hospital. The first three sessions occur in the week or two before discharge from inpatient
      or outpatient rehabilitation. At sessions 1 and 2, each lasting approximately 60 minutes,
      participants and their study partners in the experimental group are trained on how to use the
      VRT system and play the games. They are also instructed what to do if something went wrong
      (for example, if the participant falls or the equipment does not work). Participants are
      given a simple manual on VRT. Participants in the control group also attend two training
      sessions, each lasting approximately 45 minutes, on how to use the tablet and use the apps.
      Outcome measures are performed at sessions 3 (before discharge) and 4 (after 6 weeks of VRT);
      each session takes approximately 1½ hours.

      After discharge from inpatient or outpatient rehabilitation, the research physical therapist
      (PT) installs the VRT system into the participant's home and reviews the games, safety
      considerations and follow-up procedures with the participant and their study partner. The
      supervising caregiver must be in the home of the participant while he or she is doing VRT.
      The PT monitors the game and parameter selections along with time spent on VRT at least once
      a week using the remote access feature of the VRT system, and modifies the games if
      necessary.

      Participants in both groups are instructed to perform their exercise plan 5 times a week for
      6 weeks for 30 minutes at each session. This amount of additional training (15 hours) has
      been shown to produce a significant improvement in activities of daily living post-stroke.
      All participants are contacted by telephone twice a week for the first week and at least once
      a week for the following 5 weeks to offer encouragement, suggest modifications to the games
      and identify any safety issues or technical problems. Participants are also invited to
      contact the research PT as needed. Participants in both groups are encouraged to do as many
      activities of daily living (ADLs) and instrumental ADLs (IADLs) as they wish, including
      walking, participation in exercise groups and therapy. They are not prevented from undergoing
      further rehabilitation while enrolled in the feasibility study.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A prospective, single-site, single-blinded, parallel-group (1:1 ratio) randomized feasibility trial on the use of VRT for ongoing stroke rehabilitation after discharge from inpatient or outpatient stroke rehabilitation.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: The outcomes assessor does not know the participant's intervention group allocation.
measure: Recruitment rate
time frame: 18 months
description: number of participants recruited over 18 months of participant intake relative to the number who met study criteria and number who were approached
measure: Quantitative assessment of ability and compliance to research protocol
time frame: 18 months
description: assessed by monitoring the use and progression of the VRT program
measure: Qualitative assessment of ability and compliance to research protocol
time frame: 18 months
description: assessed through comments made by the participant and study partner
measure: Adverse events (incidence & type) due to home-based VRT intervention
time frame: 18 months
description: presence of adverse effects (minor and severe) recorded from telephone conversations and through log book
measure: Ability to use VRT in the home
time frame: 18 months
description: assessed through comments made by the participant and study partner
measure: Quantitative assessment of acceptability of VRT intervention
time frame: 18 months
description: assessed with the Physical Activity Enjoyment Scale
measure: Qualitative assessment of acceptability of VRT intervention
time frame: 18 months
description: assessed through comments made by the participant and study partner
measure: Estimate cost for a future definitive RCT
time frame: 18 months
description: calculate costs of all components of this study
measure: Ability of participants to perform Berg Balance Scale without quitting due to fatigue or frustration
time frame: 18 months
description: 1) Berg Balance Scale (BBS, Berg et al.)
measure: Ability of participants to perform Timed Up & Go (original version) without quitting due to fatigue or frustration
time frame: 18 months
description: Timed Up And Go (TUG, original version, Campbell et al.)
measure: Ability of participants to perform Timed Up & Go (manual version) without quitting due to fatigue or frustration
time frame: 18 months
description: Timed Up And Go (TUG, manual version, Hofheinz & Schusterschitz)
measure: Ability of participants to perform Timed Up & Go (cognitive version) without quitting due to fatigue or frustration
time frame: 18 months
description: Timed Up And Go (TUG, cognitive version, Lundin-Olsson et al.)
measure: Ability of participants to perform Five Times Sit-to-Stand without quitting due to fatigue or frustration
time frame: 18 months
description: Five Times Sit-to-Stand Test (FTSST, Bohannon et al.)
measure: Ability of participants to perform Community Balance & Mobility Scale without quitting due to fatigue or frustration
time frame: 18 months
description: Community Balance & Mobility Scale (CBM, Howe et al.)
measure: Ability of participants to perform quantitative analysis of quiet stance in standing without quitting due to fatigue or frustration
time frame: 18 months
description: movement of the centre of pressure on a force plate during quiet stance in standing (Preuss & Popovic)
measure: Ability of participants to perform quantitative analysis of limits of stability in standing without quitting due to fatigue or frustration
time frame: 18 months
description: quantitative assessment of the limits of stability in standing done on a force plate (Preuss & Popovic)
measure: Potential for home-based VRT to maintain or improve performance on the Berg Balance Scale
time frame: 18 months
description: Berg Balance Scale (BBS, Berg et al.)
measure: Potential for home-based VRT to maintain or improve performance on the Timed Up And Go scale (original version)
time frame: 18 months
description: Timed Up And Go (original version, Campbell et al.)
measure: Potential for home-based VRT to maintain or improve performance on the Timed Up And Go scale (manual version)
time frame: 18 months
description: Timed Up And Go (manual version, Hofheinz & Schusterschitz)
measure: Potential for home-based VRT to maintain or improve performance on the Timed Up And Go scale (cognitive version)
time frame: 18 months
description: Timed Up And Go (cognitive version, Lundin-Olsson et al.)
measure: Potential for home-based VRT to maintain or improve performance on the Five Times Sit-To-Stand Test
time frame: 18 months
description: Five Times Sit-To-Stand Test (FTSST, Bohannon et al.)
measure: Potential for home-based VRT to maintain or improve performance on the Community Balance and Mobility Scale
time frame: 18 months
description: Community Balance and Mobility Scale (CBM, Howe et al.)
measure: Potential for home-based VRT to maintain or improve performance on quantitative analyses of quiet stance and limits of stability in standing
time frame: 18 months
description: quantitative analyses of quiet stance and limits of stability in standing (Preuss & Popovic)
measure: Potential for home-based VRT to maintain or improve performance on the Stroke Impact Scale
time frame: 18 months
description: Stroke Impact Scale (SIS, Duncan et al.)
measure: Potential for home-based VRT to maintain or improve performance on the Reintegration to Normal Living Index
time frame: 18 months
description: Reintegration to Normal Living Index (RNLI, Spitzer et al).
measure: Determine a sample size for a definitive RCT on home-based VRT
time frame: 18 months
description: Results of the Berg Balance Scale (BBS, Berg et al.) to calculate sample size.
arm group label: Virtual Reality
arm group type: Experimental
description: Virtual reality training designed to train standing balance, reaching, stepping, gentle strengthening and aerobic conditioning.
arm group label: Control
arm group type: Active Comparator
description: iPad apps designed to train memory, cognition, visual tracking and fine motor skills.
intervention type: Device
intervention name: Virtual reality
description: Virtual reality training is provided using Jintronix Rehabilitation software. A Kinect camera captures the movements of the participant using infrared technology and allows them to control an avatar, which interacts with an activity. Several games and activities are available to train standing balance (ex. slalom skiing), reaching (ex. planting seeds/harvesting tomatoes), stepping (ex. whack-a-mole), gentle strengthening (ex. knee extensions) and aerobic exercises (ex. marching on the spot). Game and activity difficulty can be increased by requiring more repetitions, or greater speed, distance and/or accuracy. Specific games and activities, and their parameters are customized for each participant. The exercise plan is performed 5 times a week for 6 weeks for 30 minutes at each session.
arm group label: Virtual Reality
intervention type: Device
intervention name: Control
description: Participants in the control group are provided with an iPad which contains a selection of apps suited for memory (ex. memory card game), cognition (Sudoku, cross-word), visual tracking (word search) and fine motor skills (ex. writing, whack-a-mole). Participants are instructed to perform their exercise plan 5 times a week for 6 weeks for 30 minutes at each session.
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hillel Finestone, MD
role: Principal Investigator
affiliation: Bruyere Continuing Care
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Stroke
sharing ipd: No