Clinical trial NCT03830372: "VRTierOne" as a Method Supporting the Post-stroke Rehabilitation
Official title: Evaluation of the Effectiveness of the "VRTierOne" Virtual Therapeutic Game as a Method Supporting the Post-stroke Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Depression
Keywords: stroke
post-stroke rehabilitation
virtual reality
depression
mental health
Lead sponsor: Wroclaw University of Health and Sport Sciences
Sponsor class: OTHER
Collaborators: name: National Center for Research and Development, Poland
name: Przedsiębiorstwo Produkcyjno Usługowe STOLGRAF
name: IRCCS San Camillo, Venezia, Italy
name: Foundation for Senior Citizen Activation SIWY DYM
First posted: 2019-02-05
Enrollment: 39
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Ischemic stroke
* depression symptoms scored 10 and more in Geriatric Depression Scale (GDS-30)

Exclusion Criteria:

* cognitive functions (MMSE\<24)
* epilepsy,
* vertigo,
* aphasia and a serious loss of sight or hearing that makes it impossible to assess cognitive functions based on MMSE,
* presence at the time of the examination or in the medical data: mental retardation, disturbances of consciousness or other serious mental disorders,
* patient's refusal at any stage of the research project

Primary outcomes:
measure: The Geriatric Depression Scale (GDS)
timeFrame: 20 minutes
measure: Generalized Self-Efficacy Scale (GSES)
timeFrame: 20 minutes
measure: Acceptance of Illnes Scale (AIS)
timeFrame: 10 minutes
measure: The Visual Analogue Scale of Pain (VAS)
timeFrame: 3 minute
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 15 minutes
Secondary outcomes:
measure: The Barthel Index (BI)
timeFrame: 30 minutes
measure: Lawton's Scale
timeFrame: 30 minutes
measure: Rivermead Motor Assesment (RMA)
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Venice
country: Italy
facility: Fondazione Ospedale San Camillo IRCCS
city: Wroclaw
country: Poland
facility: University School of Physical Education
state: Dolnośląskie
city: Tarnowskie Góry
country: Poland
facility: Rehabilitation Centre "Repty"
state: Śląskie
Study officials:
affiliation: University School of Physical Education, Poland
name: Joanna Szczepańska-Gieracha, prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University School of Physical Education, Poland
name: Joanna Szczepańska-Gieracha, prof
role: STUDY_DIRECTOR
affiliation: Fondazione Ospedale San Camillo IRCCS
name: Pawel Kiper, PhD
role: STUDY_CHAIR
References:
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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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.