<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/NCT03830372</url>
  </required_header>
  <id_info>
    <org_study_id>POIR.01-02.00-00-0134/16</org_study_id>
    <nct_id>NCT03830372</nct_id>
  </id_info>
  <brief_title>&quot;VRTierOne&quot; as a Method Supporting the Post-stroke Rehabilitation</brief_title>
  <acronym>VRTierOne</acronym>
  <official_title>Evaluation of the Effectiveness of the &quot;VRTierOne&quot; Virtual Therapeutic Game as a Method Supporting the Post-stroke Rehabilitation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wroclaw University of Health and Sport Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Center for Research and Development, Poland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Przedsiębiorstwo Produkcyjno Usługowe STOLGRAF</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>IRCCS San Camillo, Venezia, Italy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Foundation for Senior Citizen Activation SIWY DYM</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Wroclaw University of Health and Sport Sciences</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>
      Thanks to using VR googles and the phenomenon of total immersion &quot;VR Tier One&quot; allows to&#xD;
      completely separate the patient from the hospital environment, provides an intense visual,&#xD;
      auditory and kinesthetic stimulation. Depending on the stage of therapy it can have a calming&#xD;
      and mood-improving effect or, in another part of the game, it can motivate and cognitively&#xD;
      activate the patient. The additional aim of the game is to help the patients regain their&#xD;
      emotional balance, let them recognize their resources in order to bring them to power in the&#xD;
      rehabilitation process and trigger the natural recovery mechanisms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goals of the project:&#xD;
&#xD;
        1. The evaluation of the influence of virtual therapeutic game on the mood and wellbeing of&#xD;
           the patients undergoing post-stroke rehabilitation.&#xD;
&#xD;
        2. The evaluation of the influence of virtual therapeutic game on the acceptance of the&#xD;
           illness and self-efficacy assessment of the patients undergoing post-stroke&#xD;
           rehabilitation.&#xD;
&#xD;
        3. The evaluation of the influence of virtual therapeutic game on the effectiveness of&#xD;
           post-stroke rehabilitation process in relation to locomotive function as well as basic&#xD;
           and instrumental activities of daily living.&#xD;
&#xD;
        4. The analysis of possible side effects appearing while using virtual reality therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 6, 2019</start_date>
  <completion_date type="Actual">April 3, 2020</completion_date>
  <primary_completion_date type="Actual">April 3, 2020</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>The Geriatric Depression Scale (GDS)</measure>
    <time_frame>20 minutes</time_frame>
    <description>The Geriatric Depression Scale is a self-report 30-items measure of well-being and mood in older adults. The patient responds in a &quot;Yes/No&quot; format. Scoring ranges from 0 to 30, where 11 and more means mood disorders. The higher score means the greater depression. GDS will be performed at the beginning and at the end of treatment (i.e. 3 weeks) as well as after 3 weeks of the follow-up.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Generalized Self-Efficacy Scale (GSES)</measure>
    <time_frame>20 minutes</time_frame>
    <description>Generalized Self - Efficacy Scale consists of 10 statements. In each question, the patient can get 4 points. The scale measures the strength of the general belief of the individual about the effectiveness of coping with difficult situations and unexpected events as well as determination in pursuing the goal. Scoring ranges from 10 to 40 points. The more points the patient gets, the better he assesses his effectiveness in dealing with problems. The GSES will be performed at the beginning and at the end of treatment (i.e. 3 weeks) as well as after 3 weeks of the follow-up.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptance of Illnes Scale (AIS)</measure>
    <time_frame>10 minutes</time_frame>
    <description>Acceptance of Illness Scale contains eight statements describing the consequences of poor health. Scoring is in the range of 8 to 40 points. A small number of points means no acceptance of the disease and a strong sense of mental discomfort, while a high score means adaptation to the situation and lack of negative emotions associated with the disease. The AIS will be performed at the beginning and at the end of treatment (i.e. 3 weeks) as well as after 3 weeks of the follow-up.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Visual Analogue Scale of Pain (VAS)</measure>
    <time_frame>3 minute</time_frame>
    <description>The Visual Analogue Scale of Pain is a psychometric measurement for intensity of pain, assesses the pain sensation on a scale of 0 to 10, where 0 means no pain and 10 means unbearable pain. The VAS will be performed at the beginning and at the end of treatment (i.e. 3 weeks) as well as after 3 weeks of the follow-up.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>15 minutes</time_frame>
    <description>The Hospital Anxiety and Depression Scale (HADS) is a fourteen-item scale scoring from 0 to 3 for each item. The first seven items relate to anxiety (HADS-A), and the remaining seven items relate to depression (HADS-D). The global scoring ranges from 0 to 42 with a cut-off point of 8/21 for anxiety and 8/21 for depression. The higher the score, the greater anxiety or depression symptoms. HADS will be performed at the beginning and after four weeks of treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Barthel Index (BI)</measure>
    <time_frame>30 minutes</time_frame>
    <description>Barthel Index is a method of assessing the basic activities of daily living. Scoring ranges from 0 to 100, where 100 means full independence in basic activities (self-dressing, undressing, washing, use of the toilet, eating meals, transferring from a bed to a chair etc.). The score below 20 means the need for round the clock care. BI will be performed at the beginning and at the end of treatment (i.e. 3 weeks) as well as after 3 weeks of the follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lawton's Scale</measure>
    <time_frame>30 minutes</time_frame>
    <description>Lawton's Scale assesses the instrumental activity of daily living such as using a telephone, shopping, preparing meals, household duties, washing clothes, money managing etc. The scale contains eight questions about the instrumental activities of everyday life which the patient can do without help, with a little help or is not able to do it at all. Scoring ranges from 8 to 24. The more points the more independent the patient is. The Lawton's Scale will be performed at the beginning and at the end of treatment (i.e. 3 weeks) as well as after 3 weeks of the follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rivermead Motor Assesment (RMA)</measure>
    <time_frame>30 minutes</time_frame>
    <description>The Rivermead Motor Assesment measures mobility and locomotion (e.g. changing positions, transfers, walking up stairs, etc.). 13 tasks are assessed, for each of them the patient may receive one point. The higher the score, the greater the mobility of the subject. The Rivermead Mobility Index will be performed at the beginning and at the end of treatment (i.e. 3 weeks) as well as after 3 weeks of the follow-up.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Stroke</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>VR Tier One</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive:&#xD;
10 sessions of 20 minutes of VR Tire One therapeutic game,&#xD;
60 minutes of individual physiotherapy based on the Bobath and PNF concept with elements of manual therapy,&#xD;
30 minutes individual aerobic training,&#xD;
30 minutes balance exercises.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive:&#xD;
10 sessions of 20 minutes of Schultz Autogenic Training,&#xD;
60 minutes of individual physiotherapy based on the Bobath and PNF concept with elements of manual therapy,&#xD;
30 minutes individual aerobic training,&#xD;
30 minutes balance exercises.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VR Tier One</intervention_name>
    <description>10 sessions of 20 minutes virtual terapeutic game&#xD;
Thanks to using VR googles and the phenomenon of total immersion VR Tier One terapy game allows to completely separate the patient from the hospital environment and provides an intense visual, auditory and kinesthetic stimulation. Depending on the stage of therapy it can have a calming and mood-improving effect or it can motivate and cognitively activate the patient. The additional aim of the game is to help the patients regain their emotional balance, let them recognize their resources in order to bring them to power in the rehabilitation process and trigger the natural recovery mechanisms.</description>
    <arm_group_label>VR Tier One</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>10 sessions of 20 minutes of Schultz Autogenic Training</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ischemic stroke&#xD;
&#xD;
          -  depression symptoms scored 10 and more in Geriatric Depression Scale (GDS-30)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cognitive functions (MMSE&lt;24)&#xD;
&#xD;
          -  epilepsy,&#xD;
&#xD;
          -  vertigo,&#xD;
&#xD;
          -  aphasia and a serious loss of sight or hearing that makes it impossible to assess&#xD;
             cognitive functions based on MMSE,&#xD;
&#xD;
          -  presence at the time of the examination or in the medical data: mental retardation,&#xD;
             disturbances of consciousness or other serious mental disorders,&#xD;
&#xD;
          -  patient's refusal at any stage of the research project&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joanna Szczepańska-Gieracha, prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>University School of Physical Education, Poland</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Joanna Szczepańska-Gieracha, prof</last_name>
    <role>Study Director</role>
    <affiliation>University School of Physical Education, Poland</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pawel Kiper, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Fondazione Ospedale San Camillo IRCCS</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fondazione Ospedale San Camillo IRCCS</name>
      <address>
        <city>Venice</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University School of Physical Education</name>
      <address>
        <city>Wroclaw</city>
        <state>Dolnośląskie</state>
        <zip>51-612</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rehabilitation Centre &quot;Repty&quot;</name>
      <address>
        <city>Tarnowskie Góry</city>
        <state>Śląskie</state>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
    <country>Poland</country>
  </location_countries>
  <reference>
    <citation>Li J, Theng YL, Foo S. Game-based digital interventions for depression therapy: a systematic review and meta-analysis. Cyberpsychol Behav Soc Netw. 2014 Aug;17(8):519-27. doi: 10.1089/cyber.2013.0481. Epub 2014 May 8.</citation>
    <PMID>24810933</PMID>
  </reference>
  <reference>
    <citation>McCann RA, Armstrong CM, Skopp NA, Edwards-Stewart A, Smolenski DJ, June JD, Metzger-Abamukong M, Reger GM. Virtual reality exposure therapy for the treatment of anxiety disorders: an evaluation of research quality. J Anxiety Disord. 2014 Aug;28(6):625-31. doi: 10.1016/j.janxdis.2014.05.010. Epub 2014 Jun 7.</citation>
    <PMID>25093964</PMID>
  </reference>
  <reference>
    <citation>Maples-Keller JL, Bunnell BE, Kim SJ, Rothbaum BO. The Use of Virtual Reality Technology in the Treatment of Anxiety and Other Psychiatric Disorders. Harv Rev Psychiatry. 2017 May/Jun;25(3):103-113. doi: 10.1097/HRP.0000000000000138.</citation>
    <PMID>28475502</PMID>
  </reference>
  <reference>
    <citation>Freeman D, Reeve S, Robinson A, Ehlers A, Clark D, Spanlang B, Slater M. Virtual reality in the assessment, understanding, and treatment of mental health disorders. Psychol Med. 2017 Oct;47(14):2393-2400. doi: 10.1017/S003329171700040X. Epub 2017 Mar 22.</citation>
    <PMID>28325167</PMID>
  </reference>
  <reference>
    <citation>Botella C, Serrano B, Banos RM, Garcia-Palacios A. Virtual reality exposure-based therapy for the treatment of post-traumatic stress disorder: a review of its efficacy, the adequacy of the treatment protocol, and its acceptability. Neuropsychiatr Dis Treat. 2015 Oct 3;11:2533-45. doi: 10.2147/NDT.S89542. eCollection 2015.</citation>
    <PMID>26491332</PMID>
  </reference>
  <reference>
    <citation>Diemer J, Muhlberger A, Pauli P, Zwanzger P. Virtual reality exposure in anxiety disorders: impact on psychophysiological reactivity. World J Biol Psychiatry. 2014 Aug;15(6):427-42. doi: 10.3109/15622975.2014.892632. Epub 2014 Mar 25.</citation>
    <PMID>24666248</PMID>
  </reference>
  <reference>
    <citation>Motraghi TE, Seim RW, Meyer EC, Morissette SB. Virtual reality exposure therapy for the treatment of posttraumatic stress disorder: a methodological review using CONSORT guidelines. J Clin Psychol. 2014 Mar;70(3):197-208. doi: 10.1002/jclp.22051. Epub 2013 Sep 24.</citation>
    <PMID>24108479</PMID>
  </reference>
  <reference>
    <citation>Valmaggia LR, Latif L, Kempton MJ, Rus-Calafell M. Virtual reality in the psychological treatment for mental health problems: An systematic review of recent evidence. Psychiatry Res. 2016 Feb 28;236:189-195. doi: 10.1016/j.psychres.2016.01.015. Epub 2016 Jan 12.</citation>
    <PMID>26795129</PMID>
  </reference>
  <reference>
    <citation>Tsirlin I, Dupierrix E, Chokron S, Coquillart S, Ohlmann T. Uses of virtual reality for diagnosis, rehabilitation and study of unilateral spatial neglect: review and analysis. Cyberpsychol Behav. 2009 Apr;12(2):175-81. doi: 10.1089/cpb.2008.0208.</citation>
    <PMID>19361298</PMID>
  </reference>
  <reference>
    <citation>Rizzo A', Shilling R. Clinical Virtual Reality tools to advance the prevention, assessment, and treatment of PTSD. Eur J Psychotraumatol. 2017 Jan 16;8(sup5):1414560. doi: 10.1080/20008198.2017.1414560. eCollection 2017.</citation>
    <PMID>29372007</PMID>
  </reference>
  <reference>
    <citation>Negut A, Matu SA, Sava FA, David D. Virtual reality measures in neuropsychological assessment: a meta-analytic review. Clin Neuropsychol. 2016 Feb;30(2):165-84. doi: 10.1080/13854046.2016.1144793. Epub 2016 Feb 29.</citation>
    <PMID>26923937</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>June 22, 2020</last_update_submitted>
  <last_update_submitted_qc>June 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wroclaw University of Health and Sport Sciences</investigator_affiliation>
    <investigator_full_name>Joanna Szczepańska-Gieracha</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>stroke</keyword>
  <keyword>post-stroke rehabilitation</keyword>
  <keyword>virtual reality</keyword>
  <keyword>depression</keyword>
  <keyword>mental health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Depression</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/NCT03830372
org study id: POIR.01-02.00-00-0134/16
nct id: NCT03830372
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Thanks to using VR googles and the phenomenon of total immersion "VR Tier One" allows to
      completely separate the patient from the hospital environment, provides an intense visual,
      auditory and kinesthetic stimulation. Depending on the stage of therapy it can have a calming
      and mood-improving effect or, in another part of the game, it can motivate and cognitively
      activate the patient. The additional aim of the game is to help the patients regain their
      emotional balance, let them recognize their resources in order to bring them to power in the
      rehabilitation process and trigger the natural recovery mechanisms.
The goals of the project:

        1. The evaluation of the influence of virtual therapeutic game on the mood and wellbeing of
           the patients undergoing post-stroke rehabilitation.

        2. The evaluation of the influence of virtual therapeutic game on the acceptance of the
           illness and self-efficacy assessment of the patients undergoing post-stroke
           rehabilitation.

        3. The evaluation of the influence of virtual therapeutic game on the effectiveness of
           post-stroke rehabilitation process in relation to locomotive function as well as basic
           and instrumental activities of daily living.

        4. The analysis of possible side effects appearing while using virtual reality therapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: The Geriatric Depression Scale (GDS)
time frame: 20 minutes
description: The Geriatric Depression Scale is a self-report 30-items measure of well-being and mood in older adults. The patient responds in a "Yes/No" format. Scoring ranges from 0 to 30, where 11 and more means mood disorders. The higher score means the greater depression. GDS will be performed at the beginning and at the end of treatment (i.e. 3 weeks) as well as after 3 weeks of the follow-up.
measure: Generalized Self-Efficacy Scale (GSES)
time frame: 20 minutes
description: Generalized Self - Efficacy Scale consists of 10 statements. In each question, the patient can get 4 points. The scale measures the strength of the general belief of the individual about the effectiveness of coping with difficult situations and unexpected events as well as determination in pursuing the goal. Scoring ranges from 10 to 40 points. The more points the patient gets, the better he assesses his effectiveness in dealing with problems. The GSES will be performed at the beginning and at the end of treatment (i.e. 3 weeks) as well as after 3 weeks of the follow-up.
measure: Acceptance of Illnes Scale (AIS)
time frame: 10 minutes
description: Acceptance of Illness Scale contains eight statements describing the consequences of poor health. Scoring is in the range of 8 to 40 points. A small number of points means no acceptance of the disease and a strong sense of mental discomfort, while a high score means adaptation to the situation and lack of negative emotions associated with the disease. The AIS will be performed at the beginning and at the end of treatment (i.e. 3 weeks) as well as after 3 weeks of the follow-up.
measure: The Visual Analogue Scale of Pain (VAS)
time frame: 3 minute
description: The Visual Analogue Scale of Pain is a psychometric measurement for intensity of pain, assesses the pain sensation on a scale of 0 to 10, where 0 means no pain and 10 means unbearable pain. The VAS will be performed at the beginning and at the end of treatment (i.e. 3 weeks) as well as after 3 weeks of the follow-up.
measure: Hospital Anxiety and Depression Scale (HADS)
time frame: 15 minutes
description: The Hospital Anxiety and Depression Scale (HADS) is a fourteen-item scale scoring from 0 to 3 for each item. The first seven items relate to anxiety (HADS-A), and the remaining seven items relate to depression (HADS-D). The global scoring ranges from 0 to 42 with a cut-off point of 8/21 for anxiety and 8/21 for depression. The higher the score, the greater anxiety or depression symptoms. HADS will be performed at the beginning and after four weeks of treatment.
measure: The Barthel Index (BI)
time frame: 30 minutes
description: Barthel Index is a method of assessing the basic activities of daily living. Scoring ranges from 0 to 100, where 100 means full independence in basic activities (self-dressing, undressing, washing, use of the toilet, eating meals, transferring from a bed to a chair etc.). The score below 20 means the need for round the clock care. BI will be performed at the beginning and at the end of treatment (i.e. 3 weeks) as well as after 3 weeks of the follow-up.
measure: Lawton's Scale
time frame: 30 minutes
description: Lawton's Scale assesses the instrumental activity of daily living such as using a telephone, shopping, preparing meals, household duties, washing clothes, money managing etc. The scale contains eight questions about the instrumental activities of everyday life which the patient can do without help, with a little help or is not able to do it at all. Scoring ranges from 8 to 24. The more points the more independent the patient is. The Lawton's Scale will be performed at the beginning and at the end of treatment (i.e. 3 weeks) as well as after 3 weeks of the follow-up.
measure: Rivermead Motor Assesment (RMA)
time frame: 30 minutes
description: The Rivermead Motor Assesment measures mobility and locomotion (e.g. changing positions, transfers, walking up stairs, etc.). 13 tasks are assessed, for each of them the patient may receive one point. The higher the score, the greater the mobility of the subject. The Rivermead Mobility Index will be performed at the beginning and at the end of treatment (i.e. 3 weeks) as well as after 3 weeks of the follow-up.
arm group label: VR Tier One
arm group type: Experimental
description: Patients will receive:
10 sessions of 20 minutes of VR Tire One therapeutic game,
60 minutes of individual physiotherapy based on the Bobath and PNF concept with elements of manual therapy,
30 minutes individual aerobic training,
30 minutes balance exercises.
arm group label: Control
arm group type: Active Comparator
description: Patients will receive:
10 sessions of 20 minutes of Schultz Autogenic Training,
60 minutes of individual physiotherapy based on the Bobath and PNF concept with elements of manual therapy,
30 minutes individual aerobic training,
30 minutes balance exercises.
intervention type: Device
intervention name: VR Tier One
description: 10 sessions of 20 minutes virtual terapeutic game
Thanks to using VR googles and the phenomenon of total immersion VR Tier One terapy game allows to completely separate the patient from the hospital environment and provides an intense visual, auditory and kinesthetic stimulation. Depending on the stage of therapy it can have a calming and mood-improving effect or it can motivate and cognitively activate the patient. The additional aim of the game is to help the patients regain their emotional balance, let them recognize their resources in order to bring them to power in the rehabilitation process and trigger the natural recovery mechanisms.
arm group label: VR Tier One
intervention type: Other
intervention name: Control
description: 10 sessions of 20 minutes of Schultz Autogenic Training
arm group label: Control
criteria: 
gender: All
minimum age: 55 Years
maximum age: 75 Years
healthy volunteers: No
last name: Joanna Szczepańska-Gieracha, prof
role: Principal Investigator
affiliation: University School of Physical Education, Poland
last name: Joanna Szczepańska-Gieracha, prof
role: Study Director
affiliation: University School of Physical Education, Poland
last name: Pawel Kiper, PhD
role: Study Chair
affiliation: Fondazione Ospedale San Camillo IRCCS
facility: 
facility: 
facility: 
country: Italy
country: Poland
citation: Li J, Theng YL, Foo S. Game-based digital interventions for depression therapy: a systematic review and meta-analysis. Cyberpsychol Behav Soc Netw. 2014 Aug;17(8):519-27. doi: 10.1089/cyber.2013.0481. Epub 2014 May 8.
PMID: 24810933
citation: McCann RA, Armstrong CM, Skopp NA, Edwards-Stewart A, Smolenski DJ, June JD, Metzger-Abamukong M, Reger GM. Virtual reality exposure therapy for the treatment of anxiety disorders: an evaluation of research quality. J Anxiety Disord. 2014 Aug;28(6):625-31. doi: 10.1016/j.janxdis.2014.05.010. Epub 2014 Jun 7.
PMID: 25093964
citation: Maples-Keller JL, Bunnell BE, Kim SJ, Rothbaum BO. The Use of Virtual Reality Technology in the Treatment of Anxiety and Other Psychiatric Disorders. Harv Rev Psychiatry. 2017 May/Jun;25(3):103-113. doi: 10.1097/HRP.0000000000000138.
PMID: 28475502
citation: Freeman D, Reeve S, Robinson A, Ehlers A, Clark D, Spanlang B, Slater M. Virtual reality in the assessment, understanding, and treatment of mental health disorders. Psychol Med. 2017 Oct;47(14):2393-2400. doi: 10.1017/S003329171700040X. Epub 2017 Mar 22.
PMID: 28325167
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responsible party type: Principal Investigator
investigator affiliation: Wroclaw University of Health and Sport Sciences
investigator full name: Joanna Szczepańska-Gieracha
investigator title: Professor
mesh term: Stroke
mesh term: Depression
sharing ipd: No