"VRTierOne" as a Method Supporting the Post-stroke Rehabilitation

NCT03830372 | Completed

• 1 other identifier: POIR.01-02.00-00-0134/16
• Study Type: interventional
• Target: 39
• Locations: 2 countries
• Sites: 3

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.

Conditions

Stroke; Depression

Keywords

stroke; post-stroke rehabilitation; virtual reality; depression; mental health

Outcome Measures

Primary Outcomes (5)

• 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.

  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

Secondary Outcomes (3)

• The Barthel Index (BI)

  30 minutes

• Lawton's Scale

  30 minutes

• Rivermead Motor Assesment (RMA)

  30 minutes

Study Arms (2)

VR Tier One

EXPERIMENTAL

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.

Device: VR Tier One

Control

ACTIVE COMPARATOR

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.

Other: Control

Interventions

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.

VR Tier One

Control OTHER

10 sessions of 20 minutes of Schultz Autogenic Training

Control

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wroclaw University of Health and Sport Sciences: lead
• National Center for Research and Development, Poland: collaborator
• Przedsiębiorstwo Produkcyjno Usługowe STOLGRAF: collaborator
• IRCCS San Camillo, Venezia, Italy: collaborator
• Foundation for Senior Citizen Activation SIWY DYM: collaborator

Study Sites (3)

Fondazione Ospedale San Camillo IRCCS

Venice, Italy

Location

University School of Physical Education

Wroclaw, Lower Silesian Voivodeship, 51-612, Poland

Location

Rehabilitation Centre "Repty"

Tarnowskie Góry, Silesian Voivodeship, Poland

Location

Related Publications (13)

• 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 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.

  PMID: 25093964 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.

  PMID: 28475502 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.

  PMID: 28325167 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.

  PMID: 26491332 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.

  PMID: 24666248 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.

  PMID: 24108479 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.

  PMID: 26795129 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.

  PMID: 19361298 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.

  PMID: 29372007 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.

  PMID: 26923937 BACKGROUND

• 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.

  PMID: 37864252 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.

  PMID: 36447623 DERIVED

MeSH Terms

Conditions

Stroke; Depression; Psychological Well-Being

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior; Personal Satisfaction

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: February 5, 2019
• Study Start: May 6, 2019
• Primary Completion: April 3, 2020
• Study Completion: April 3, 2020
• Last Updated: June 23, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2); IT (1)