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 Russia

Status: Completed

Conditions: Emotional Disturbances; Virtual Reality; Aphasia

Treatments: Behavioral: Relaxation in virtual reality

Study type: Interventional

Funder types: Other

Identifiers

NCT04533308

NMSC-02-20

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

VR intervention

Experimental group

Description:

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).

Treatment:

Behavioral: Relaxation in virtual reality

Control

No Intervention group

Description:

Patients in the control group will not receive any psychological interventions.