AphasiaNCT04533308
The Impact of Virtual Reality on the Emotional State of Patients With Aphasia During Rehabilitation.
A study testing Relaxation in virtual reality in people with Aphasia and Virtual Reality, run by State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Aphasia, Virtual Reality, Emotional Disturbances
- What is being tested?
- Relaxation in virtual reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteRussia
- Study dates
- 20 Aug 2020to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to determine virtual reality (VR) impact during standard program of rehabilitation on emotional state of patients with aphasia.
Read the 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.
- Conditions
- Aphasia, Virtual Reality, Emotional Disturbances
- Being tested
- Relaxation in virtual reality
- Medical subject headings
- Aphasia, Affective Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation in virtual realityBehavioural
Natural 360-degrees scenes from different locations in the world with or without interactions with animals in the virtual reality
| Study group | Role | What they receive |
|---|---|---|
| VR intervention | Experimental | 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). Receives: Behavioral: Relaxation in virtual reality |
| Control | No intervention | Patients in the control group will not receive any psychological interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The absence of severe adverse reactions
Assessed by a self-reported form and physiological parameters
Measured: From admission to discharge, up to 3 weeks
Secondary outcomes (6)
10 - Stroke Aphasic Depression Questionnaire (SADQH-10)
Scores range from 0 to 30 with lower scores denoting better outcomes.
Measured: 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.
Measured: From admission to discharge, up to 3 weeks
Perceived Stress Scale (PSS)
Scores range from 0 to 50 with lower scores denoting better outcomes.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From admission to discharge, up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start20 Aug 2020
- Primary completion1 Sep 2021
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eduard Novak, State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
- Investigators
- Vadim D Daminov, Prof, Principal investigator, Pirogov National Medical Surgical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533308
- Sponsor's protocol ID
- NMSC-02-20
- Status last verified
- Oct 2022
- First submitted
- 26 Aug 2020
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Virtual Reality on the Emotional State of Patients With Aphasia During Rehabilitation.
- ClinicalTrials.gov ID
- NCT04533308
- Acronym / sponsor ID
- NMSC-02-20
- Conditions
- Aphasia, Virtual Reality, Emotional Disturbances
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of RussiaUniversity, hospital or other
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 31 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR intervention | Experimental | Behavioral: Relaxation in virtual realityParticipants 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). |
| Control | No intervention | –Patients in the control group will not receive any psychological interventions. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relaxation in virtual realityNatural 360-degrees scenes from different locations in the world with or without interactions with animals in the virtual reality | Behavioural | VR intervention |
Primary outcome
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
6 secondary outcomes
10 - Stroke Aphasic Depression Questionnaire (SADQH-10)
Time frame: From admission to discharge, up to 3 weeks
Visual Analog Mood Scale (VAMS)
Time frame: From admission to discharge, up to 3 weeks
Perceived Stress Scale (PSS)
Time frame: From admission to discharge, up to 3 weeks
Three-level European quality of life five-dimensional questionnaire
Time frame: From admission to discharge, up to 3 weeks
Aphasic Depression Rating Scale (ADRS)
Time frame: From admission to discharge, up to 3 weeks
Lüscher Color Test
Time frame: From admission to discharge, up to 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Individual participant dataSharing planned: Yes
Related trials for Aphasia
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Not yet recruiting
Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia (BG-Aphasia-02)
Aphasia, ALS
Not yet recruiting
Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke
Aphasia, Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vadim D Daminov, Prof principal investigator
Pirogov National Medical Surgical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation in virtual reality in people with Aphasia and Virtual Reality, run by State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The absence of severe adverse reactions (time frame: From admission to discharge, up to 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.