Clinical trial NCT04533308: The Impact of Virtual Reality on the Emotional State of Patients With Aphasia During Rehabilitation.
Official title: The Impact of Virtual Reality on the Emotional State of Patients With Aphasia During Rehabilitation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia
Virtual Reality
Emotional Disturbances
Lead sponsor: State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
Sponsor class: OTHER
First posted: 2020-08-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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
* 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

Primary outcomes:
measure: The absence of severe adverse reactions
timeFrame: From admission to discharge, up to 3 weeks
Secondary outcomes:
measure: 10 - Stroke Aphasic Depression Questionnaire (SADQH-10)
timeFrame: From admission to discharge, up to 3 weeks
measure: Visual Analog Mood Scale (VAMS)
timeFrame: From admission to discharge, up to 3 weeks
measure: Perceived Stress Scale (PSS)
timeFrame: From admission to discharge, up to 3 weeks
measure: Three-level European quality of life five-dimensional questionnaire
timeFrame: From admission to discharge, up to 3 weeks
measure: Aphasic Depression Rating Scale (ADRS)
timeFrame: From admission to discharge, up to 3 weeks
measure: Lüscher Color Test
timeFrame: From admission to discharge, up to 3 weeks
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Pirogov National Medical and Surgical Center
Study officials:
affiliation: Pirogov National Medical and Surgical Center
name: Vadim D Daminov, Prof
role: PRINCIPAL_INVESTIGATOR
References: