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Completed

NCT Number: NCT04533308

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pirogov National Medical and Surgical Center

Moscow, 105037, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. The absence of severe adverse reactions

    Time frame: From admission to discharge, up to 3 weeks

    Assessed by a self-reported form and physiological parameters

Secondary outcomes

  1. 10 - Stroke Aphasic Depression Questionnaire (SADQH-10)

    Time frame: From admission to discharge, up to 3 weeks

    Scores range from 0 to 30 with lower scores denoting better outcomes.

  2. Visual Analog Mood Scale (VAMS)

    Time frame: From admission to discharge, up to 3 weeks

    Scores range from 0 to 10 with lower scores denoting better outcomes.

  3. Perceived Stress Scale (PSS)

    Time frame: From admission to discharge, up to 3 weeks

    Scores range from 0 to 50 with lower scores denoting better outcomes.

  4. Three-level European quality of life five-dimensional questionnaire

    Time frame: 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.

  5. Aphasic Depression Rating Scale (ADRS)

    Time frame: From admission to discharge, up to 3 weeks

    Scores range from 0 to 36 with lower scores denoting better outcomes.

  6. Lüscher Color Test

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Aug 31, 2020
Registry last updated
Nov 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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