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

NCT ID: NCT04533308

Last Updated: 2022-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-20
• Study Completion Date: 2022-08-01

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.

Conditions

Aphasia; Virtual Reality; Emotional Disturbances

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

VR intervention

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).

Group Type: EXPERIMENTAL

Relaxation in virtual reality

Intervention Type: BEHAVIORAL

Natural 360-degrees scenes from different locations in the world with or without interactions with animals in the virtual reality

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Relaxation in virtual reality

Natural 360-degrees scenes from different locations in the world with or without interactions with animals in the virtual reality

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Eduard Novak

MD, MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vadim D Daminov, Prof

Role: PRINCIPAL_INVESTIGATOR

Pirogov National Medical and Surgical Center

Locations

Pirogov National Medical and Surgical Center

Moscow, , Russia

Countries

Russia

Other Identifiers

NMSC-02-20

Identifier Type: -

Identifier Source: org_study_id