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

NCT04533308 | Completed

• 1 other identifier: NMSC-02-20
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Aphasia; Virtual Reality; Emotional Disturbances

Outcome Measures

Primary Outcomes (1)

• The absence of severe adverse reactions

  Assessed by a self-reported form and physiological parameters

  From admission to discharge, up to 3 weeks

Secondary Outcomes (6)

• 10 - Stroke Aphasic Depression Questionnaire (SADQH-10)

  From admission to discharge, up to 3 weeks

• Visual Analog Mood Scale (VAMS)

  From admission to discharge, up to 3 weeks

• Perceived Stress Scale (PSS)

  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

• Aphasic Depression Rating Scale (ADRS)

  From admission to discharge, up to 3 weeks

Study Arms (2)

VR intervention

EXPERIMENTAL

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).

Behavioral: Relaxation in virtual reality

Control

NO INTERVENTION

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

Interventions

Relaxation in virtual reality BEHAVIORAL

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

VR intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Pirogov National Medical and Surgical Center

Moscow, 105037, Russia

Location

MeSH Terms

Conditions

Aphasia; Affective Symptoms

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Vadim D Daminov, Prof

  Pirogov National Medical and Surgical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: August 31, 2020
• Study Start: August 20, 2020
• Primary Completion: September 1, 2021
• Study Completion: August 1, 2022
• Last Updated: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 1 year after completion of the trial
• Access Criteria: upon request

Locations

RU (1)