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

Not Applicable

Completed

• Conditions: Virtual Reality; Aphasia; Emotional Disturbances
• Interventions: Behavioral: Relaxation in virtual reality

• Registration Number: NCT04533308
• Lead Sponsor: State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia

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.

Study Timeline

• Study Start: 2020-08-20
• Study First Submitted: 2020-08-26
• Study First Submitted QC: 2020-08-26
• Study First Posted: 2020-08-31
• Primary Completion: 2021-09-01
• Study Completion: 2022-08-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VR intervention	Relaxation in virtual reality	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).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Visual Analog Mood Scale (VAMS)	From admission to discharge, up to 3 weeks	Scores range from 0 to 10 with lower scores denoting better outcomes.
Three-level European quality of life five-dimensional questionnaire	From admission to discharge, up to 3 weeks	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.
10 - Stroke Aphasic Depression Questionnaire (SADQH-10)	From admission to discharge, up to 3 weeks	Scores range from 0 to 30 with lower scores denoting better outcomes.
Perceived Stress Scale (PSS)	From admission to discharge, up to 3 weeks	Scores range from 0 to 50 with lower scores denoting better outcomes.
Lüscher Color Test	From admission to discharge, up to 3 weeks	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.
Aphasic Depression Rating Scale (ADRS)	From admission to discharge, up to 3 weeks	Scores range from 0 to 36 with lower scores denoting better outcomes.

Trial Locations

Locations (1)

Pirogov National Medical and Surgical Center; 🇷🇺 Moscow, Russian Federation