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| Name | Class |
|---|---|
| National Center for Research and Development, Poland | OTHER |
| Przedsiębiorstwo Produkcyjno Usługowe STOLGRAF | UNKNOWN |
| IRCCS San Camillo, Venezia, Italy | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR Tier One | Experimental | Patients will receive:
|
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| Control | Active Comparator | Patients will receive:
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VR Tier One | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The Geriatric Depression Scale (GDS) | 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. | 20 minutes |
| Generalized Self-Efficacy Scale (GSES) | 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. | 20 minutes |
| Acceptance of Illnes Scale (AIS) | 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. | 10 minutes |
| The Visual Analogue Scale of Pain (VAS) | 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 | Description | Time Frame |
|---|---|---|
| The Barthel Index (BI) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanna Szczepańska-Gieracha, prof | University School of Physical Education, Poland | Principal Investigator |
| Joanna Szczepańska-Gieracha, prof | University School of Physical Education, Poland | Study Director |
| Pawel Kiper, PhD | Fondazione Ospedale San Camillo IRCCS | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Ospedale San Camillo IRCCS | Venice | Italy | ||||
| University School of Physical Education |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24810933 | Background | 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. | |
| 25093964 | Background | 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. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D003863 | Depression |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Foundation for Senior Citizen Activation SIWY DYM |
| OTHER |
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|
| Control | Other | 10 sessions of 20 minutes of Schultz Autogenic Training |
|
| 3 minute |
| Hospital Anxiety and Depression Scale (HADS) | 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. | 15 minutes |
| 30 minutes |
| Lawton's Scale | 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. | 30 minutes |
| Rivermead Motor Assesment (RMA) | 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. | 30 minutes |
| Wroclaw |
| Lower Silesian Voivodeship |
| 51-612 |
| Poland |
| Rehabilitation Centre "Repty" | Tarnowskie Góry | Silesian Voivodeship | Poland |
| 28475502 | Background | 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. |
| 28325167 | Background | 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. |
| 26491332 | Background | 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. |
| 24666248 | Background | 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. |
| 24108479 | Background | 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. |
| 26795129 | Background | 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. |
| 19361298 | Background | 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. |
| 29372007 | Background | 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. |
| 26923937 | Background | 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. |
| 37864252 | Derived | Juszko K, Kiper P, Wrzeciono A, Cieslik B, Gajda R, Szczepanska-Gieracha J. Factors associated with the effectiveness of immersive virtual therapy in alleviating depressive symptoms during sub-acute post-stroke rehabilitation: a gender comparison. BMC Sports Sci Med Rehabil. 2023 Oct 20;15(1):137. doi: 10.1186/s13102-023-00742-z. |
| 36447623 | Derived | Kiper P, Przysiezna E, Cieslik B, Broniec-Siekaniec K, Kucinska A, Szczygiel J, Turek K, Gajda R, Szczepanska-Gieracha J. Effects of Immersive Virtual Therapy as a Method Supporting Recovery of Depressive Symptoms in Post-Stroke Rehabilitation: Randomized Controlled Trial. Clin Interv Aging. 2022 Nov 23;17:1673-1685. doi: 10.2147/CIA.S375754. eCollection 2022. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D010549 | Personal Satisfaction |