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StrokeVRTierOneNCT03830372

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

A study testing VR Tier One in people with Stroke and Depression, run by Wroclaw University of Health and Sport Sciences at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 to 75 years
Conditions the study is for
Stroke, Depression
What is being tested?
VR Tier One
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
3 sitesin 2 countries
Study dates
6 May 2019to 3 Apr 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Poland2 sites

  • Rehabilitation Centre "Repty"

    Tarnowskie Góry, Silesian Voivodeship

  • University School of Physical Education

    Wroclaw, Lower Silesian Voivodeship, 51-612

Other trials in Poland

Italy1 site

  • Fondazione Ospedale San Camillo IRCCS

    Venice

Other trials in Italy

About this study

Official title: Evaluation of the Effectiveness of the "VRTierOne" Virtual Therapeutic Game as a Method Supporting the Post-stroke Rehabilitation

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.

Read the 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.
Conditions
Stroke, Depression
Being tested
VR Tier One, Control
Keywords
stroke, post-stroke rehabilitation, virtual reality, depression, mental health
Medical subject headings
Stroke, Depression, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VR Tier OneDevice

    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.

  • ControlOther

    10 sessions of 20 minutes of Schultz Autogenic Training

Study groups in NCT03830372
Study groupRoleWhat they receive
VR Tier OneExperimentalPatients 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.
Receives: Device: VR Tier One
ControlActive comparatorPatients 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.
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 20 minutes

  2. 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.

    Measured: 20 minutes

  3. 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.

    Measured: 10 minutes

  4. 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.

    Measured: 3 minute

  5. 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.

    Measured: 15 minutes

Secondary outcomes (3)

  1. 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.

    Measured: 30 minutes

  2. 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.

    Measured: 30 minutes

  3. 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.

    Measured: 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2019
  2. Study start6 May 2019
  3. Primary completion3 Apr 2020
  4. Study completion3 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03830372
Sponsor's protocol ID
POIR.01-02.00-00-0134/16
Acronym
VRTierOne
Status last verified
Jun 2020
First submitted
1 Feb 2019
Last updated
23 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24810933

  • 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.

    PubMed 25093964

  • 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.

    PubMed 28475502

  • 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.

    PubMed 28325167

  • 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.

    PubMed 26491332

  • 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.

    PubMed 24666248

  • 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.

    PubMed 24108479

  • 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.

    PubMed 26795129

  • 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.

    PubMed 19361298

  • 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.

    PubMed 29372007

  • 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.

    PubMed 26923937

  • 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.

    PubMed 37864252

  • 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.

    PubMed 36447623

Questions about this trial

What is this clinical trial studying?

A study testing VR Tier One in people with Stroke and Depression, run by Wroclaw University of Health and Sport Sciences at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Poland, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Geriatric Depression Scale (GDS) (time frame: 20 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03830372, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2020.

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