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VRTierOne as a Method Supporting the Post-stroke Rehabilitation

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03830372
Acronym
VRTierOne
Enrollment
39
Registered
2019-02-05
Start date
2019-05-06
Completion date
2020-04-03
Last updated
2020-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Stroke

Keywords

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

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.

Interventions

DEVICEVR Tier One

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.

OTHERControl

10 sessions of 20 minutes of Schultz Autogenic Training

Sponsors

National Center for Research and Development, Poland
CollaboratorOTHER
Przedsiębiorstwo Produkcyjno Usługowe STOLGRAF
CollaboratorUNKNOWN
IRCCS San Camillo, Venezia, Italy
CollaboratorOTHER
Foundation for Senior Citizen Activation SIWY DYM
CollaboratorOTHER
Wroclaw University of Health and Sport Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
55 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Hospital Anxiety and Depression Scale (HADS)15 minutesThe 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.
Generalized Self-Efficacy Scale (GSES)20 minutesGeneralized 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.
Acceptance of Illnes Scale (AIS)10 minutesAcceptance 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.
The Visual Analogue Scale of Pain (VAS)3 minuteThe 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.
The Geriatric Depression Scale (GDS)20 minutesThe 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.

Secondary

MeasureTime frameDescription
Lawton's Scale30 minutesLawton'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.
Rivermead Motor Assesment (RMA)30 minutesThe 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.
The Barthel Index (BI)30 minutesBarthel 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.

Countries

Italy, Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026