search
Back to results

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

Primary Purpose

Aphasia, Virtual Reality, Emotional Disturbances

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Relaxation in virtual reality
Sponsored by
State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Aphasia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pirogov National Medical and Surgical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

VR intervention

Control

Arm Description

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).

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

Outcomes

Primary Outcome Measures

The absence of severe adverse reactions
Assessed by a self-reported form and physiological parameters

Secondary Outcome Measures

10 - Stroke Aphasic Depression Questionnaire (SADQH-10)
Scores range from 0 to 30 with lower scores denoting better outcomes.
Visual Analog Mood Scale (VAMS)
Scores range from 0 to 10 with lower scores denoting better outcomes.
Perceived Stress Scale (PSS)
Scores range from 0 to 50 with lower scores denoting better outcomes.
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.
Aphasic Depression Rating Scale (ADRS)
Scores range from 0 to 36 with lower scores denoting better outcomes.
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.

Full Information

First Posted
August 26, 2020
Last Updated
October 31, 2022
Sponsor
State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
search

1. Study Identification

Unique Protocol Identification Number
NCT04533308
Brief Title
The Impact of Virtual Reality on the Emotional State of Patients With Aphasia During Rehabilitation.
Official Title
The Impact of Virtual Reality on the Emotional State of Patients With Aphasia During Rehabilitation.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
August 20, 2020 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
August 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Virtual Reality, Emotional Disturbances

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VR intervention
Arm Type
Experimental
Arm Description
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).
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients in the control group will not receive any psychological interventions.
Intervention Type
Behavioral
Intervention Name(s)
Relaxation in virtual reality
Intervention Description
Natural 360-degrees scenes from different locations in the world with or without interactions with animals in the virtual reality
Primary Outcome Measure Information:
Title
The absence of severe adverse reactions
Description
Assessed by a self-reported form and physiological parameters
Time Frame
From admission to discharge, up to 3 weeks
Secondary Outcome Measure Information:
Title
10 - Stroke Aphasic Depression Questionnaire (SADQH-10)
Description
Scores range from 0 to 30 with lower scores denoting better outcomes.
Time Frame
From admission to discharge, up to 3 weeks
Title
Visual Analog Mood Scale (VAMS)
Description
Scores range from 0 to 10 with lower scores denoting better outcomes.
Time Frame
From admission to discharge, up to 3 weeks
Title
Perceived Stress Scale (PSS)
Description
Scores range from 0 to 50 with lower scores denoting better outcomes.
Time Frame
From admission to discharge, up to 3 weeks
Title
Three-level European quality of life five-dimensional questionnaire
Description
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.
Time Frame
From admission to discharge, up to 3 weeks
Title
Aphasic Depression Rating Scale (ADRS)
Description
Scores range from 0 to 36 with lower scores denoting better outcomes.
Time Frame
From admission to discharge, up to 3 weeks
Title
Lüscher Color Test
Description
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.
Time Frame
From admission to discharge, up to 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vadim D Daminov, Prof
Organizational Affiliation
Pirogov National Medical and Surgical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pirogov National Medical and Surgical Center
City
Moscow
ZIP/Postal Code
105037
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
1 year after completion of the trial
IPD Sharing Access Criteria
upon request

Learn more about this trial

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

We'll reach out to this number within 24 hrs