Aphasia, Emotional Disturbances, Virtual Reality
Conditions
Brief summary
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
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.
Interventions
BEHAVIORALRelaxation in virtual reality
Natural 360-degrees scenes from different locations in the world with or without interactions with animals in the virtual reality
Sponsors
State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The absence of severe adverse reactions | From admission to discharge, up to 3 weeks | Assessed by a self-reported form and physiological parameters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 10 - Stroke Aphasic Depression Questionnaire (SADQH-10) | From admission to discharge, up to 3 weeks | Scores range from 0 to 30 with lower scores denoting better outcomes. |
| Visual Analog Mood Scale (VAMS) | From admission to discharge, up to 3 weeks | Scores range from 0 to 10 with lower scores denoting better outcomes. |
| Lüscher Color Test | From admission to discharge, up to 3 weeks | 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. |
| Three-level European quality of life five-dimensional questionnaire | From admission to discharge, up to 3 weeks | 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. |
| Aphasic Depression Rating Scale (ADRS) | From admission to discharge, up to 3 weeks | Scores range from 0 to 36 with lower scores denoting better outcomes. |
| Perceived Stress Scale (PSS) | From admission to discharge, up to 3 weeks | Scores range from 0 to 50 with lower scores denoting better outcomes. |
Countries
Russia
Outcome results
None listed