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

Virtual Reality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04533308
• Other study ID #: NMSC-02-20
• Status: Completed
• Phase: N/A
• Start date: August 20, 2020
• Est. completion date: August 1, 2022

Study information

• Verified date: October 2022
• Source: State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 1, 2022
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Affective Symptoms
• Aphasia
• Emotional Disturbances
• Virtual Reality

Intervention

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

Locations

Country	Name	City	State
Russian Federation	Pirogov National Medical and Surgical Center	Moscow

Sponsors (1)

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

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The absence of severe adverse reactions	Assessed by a self-reported form and physiological parameters	From admission to discharge, up to 3 weeks
Secondary	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
Secondary	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
Secondary	Perceived Stress Scale (PSS)	Scores range from 0 to 50 with lower scores denoting better outcomes.	From admission to discharge, up to 3 weeks
Secondary	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
Secondary	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
Secondary	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