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

State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia1 site in 1 country40 target enrollmentAugust 20, 2020

ConditionsAphasia Virtual Reality Emotional Disturbances

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aphasia
Sponsor: State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
Enrollment: 40
Locations: 1
Primary Endpoint: The absence of severe adverse reactions
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 20, 2020

End Date

August 1, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia

Responsible Party

Principal Investigator

Eduard Novak

MD, MSc

State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia

Eligibility Criteria

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
•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

Outcomes

Primary Outcomes

The absence of severe adverse reactions

Time Frame: From admission to discharge, up to 3 weeks

Assessed by a self-reported form and physiological parameters

Secondary Outcomes

Visual Analog Mood Scale (VAMS)(From admission to discharge, up to 3 weeks)
Three-level European quality of life five-dimensional questionnaire(From admission to discharge, up to 3 weeks)
10 - Stroke Aphasic Depression Questionnaire (SADQH-10)(From admission to discharge, up to 3 weeks)
Perceived Stress Scale (PSS)(From admission to discharge, up to 3 weeks)
Lüscher Color Test(From admission to discharge, up to 3 weeks)
Aphasic Depression Rating Scale (ADRS)(From admission to discharge, up to 3 weeks)