The Impact of Virtual Reality on the Emotional State of Patients With Aphasia During Rehabilitation.

Study Overview
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Brief Summary
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The aim of the study is to determine virtual reality (VR) impact during standard program of rehabilitation on emotional state of patients with aphasia.

Detailed Description
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Aim 1: To test the safety of virtual reality in a vulnerable population of patients with aphasia during rehabilitation. Participants will be alternately assigned to receiving a relaxation session in VR every working day during a standard course of rehabilitation. Aim 2: To test the preliminary efficacy of combining VR with the course of rehabilitation to promote emotional improvements in patients with aphasia.

Official Title
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The Impact of Virtual Reality on the Emotional State of Patients With Aphasia During Rehabilitation.

Conditions
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Aphasia, Virtual Reality, Emotional Disturbances

Intervention / Treatment
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* Behavioral: Relaxation in virtual reality


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mild or moderate aphasia of any type Russian is primary language At least 2 weeks post cardio-vascular accident (ischemic or hemorrhagic stroke) or head injury of any location Have a history of only one stroke Medically stable Exclusion Criteria: Associated severe cognitive deficits and psychiatric disorders which prevent patients understanding of the informed consent Epilepsy Medical history of severe visual or hearing impairment Comorbid neurological diagnosis (e.g. epilepsy, multiple sclerosis, Parkinson disease, dementia) Unable to perform the required exercises due to severe motor, sensory or cognitive deficit (memory, attention, executive functioning, apraxia, regulatory and planning activities etc.) and medical problems (for example, anyone meeting New York Heart Association Class IV criteria, hospitalization for myocardial infarction or heart surgery within 120 days, severe cardiomyopathy or documented serious and unstable cardiac arrhythmias) Drug or alcohol addiction within the last 6 months. Significant current psychiatric illness defined as affective disorder unresponsive to medication or bipolar affective disorder, psychosis, schizophrenia or suicidality Current participation in another interventional trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VR intervention<br>Participants will have a session in VR for 20-30 minutes each working day. They can choose natural 360-degrees scenes from different locations in the world with or without interactions with animals. The equipment will include HTC Vive (HTC Corporation). | Behavioral: Relaxation in virtual reality<br>* Natural 360-degrees scenes from different locations in the world with or without interactions with animals in the virtual reality<br>|
| No Intervention: Control<br>Patients in the control group will not receive any psychological interventions. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The absence of severe adverse reactions | Assessed by a self-reported form and physiological parameters | From admission to discharge, up to 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10 - Stroke Aphasic Depression Questionnaire (SADQH-10) | Scores range from 0 to 30 with lower scores denoting better outcomes. | From admission to discharge, up to 3 weeks | 
| Visual Analog Mood Scale (VAMS) | Scores range from 0 to 10 with lower scores denoting better outcomes. | From admission to discharge, up to 3 weeks | 
| Perceived Stress Scale (PSS) | Scores range from 0 to 50 with lower scores denoting better outcomes. | From admission to discharge, up to 3 weeks | 
| Three-level European quality of life five-dimensional questionnaire | There are five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. Patients choice results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describe the health status. | From admission to discharge, up to 3 weeks | 
| Aphasic Depression Rating Scale (ADRS) | Scores range from 0 to 36 with lower scores denoting better outcomes. | From admission to discharge, up to 3 weeks | 
| Lüscher Color Test | Eight different colored cards are place in order of preference. The descriptive statements formed by Lüscher for each color were used to interpret the results. | From admission to discharge, up to 3 weeks |