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

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

Study Overview

• Status: Completed
• Conditions: Aphasia; Virtual Reality; Emotional Disturbances
• Intervention / Treatment: Behavioral: Relaxation in virtual reality

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 105037
    • Pirogov National Medical and Surgical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Behavioral: Relaxation in virtual reality; Natural 360-degrees scenes from different locations in the world with or without interactions with animals in the virtual reality
No Intervention: Control; Patients in the control group will not receive any psychological interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The absence of severe adverse reactions	Assessed by a self-reported form and physiological parameters	From admission to discharge, up to 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
10 - Stroke Aphasic Depression Questionnaire (SADQH-10)	Scores range from 0 to 30 with lower scores denoting better outcomes.	From admission to discharge, up to 3 weeks
Visual Analog Mood Scale (VAMS)	Scores range from 0 to 10 with lower scores denoting better outcomes.	From admission to discharge, up to 3 weeks
Perceived Stress Scale (PSS)	Scores range from 0 to 50 with lower scores denoting better outcomes.	From admission to discharge, up to 3 weeks
Three-level European quality of life five-dimensional questionnaire	There are five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. Patients choice results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describe the health status.	From admission to discharge, up to 3 weeks
Aphasic Depression Rating Scale (ADRS)	Scores range from 0 to 36 with lower scores denoting better outcomes.	From admission to discharge, up to 3 weeks
Lüscher Color Test	Eight different colored cards are place in order of preference. The descriptive statements formed by Lüscher for each color were used to interpret the results.	From admission to discharge, up to 3 weeks

Collaborators and Investigators

• Sponsor: State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
• Investigators: Principal Investigator: Vadim D Daminov, Prof, Pirogov National Medical and Surgical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2020
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): August 1, 2022

Study Registration Dates

• First Submitted: August 26, 2020
• First Submitted That Met QC Criteria: August 26, 2020
• First Posted (Actual): August 31, 2020

Study Record Updates

• Last Update Posted (Actual): November 1, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Speech Disorders; Aphasia; Affective Symptoms
• Other Study ID Numbers: NMSC-02-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: 1 year after completion of the trial
• IPD Sharing Access Criteria: upon request
• IPD Sharing Supporting Information Type: Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No