StrokeNCT04681235
Virtual Reality Training Affects on Motor Functions and Mental Health in Stroke Patients
A study testing Training on VR in people with Stroke and Motor Disorders, run by Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health at 1 site in Russia.
Trial summary
In our study, we tested the hypothesis of the safe effect applicability of motor training in the immersion high-tech polymodal VR system not only on the parameters of balance, gait, and motor status of the patient, but also on his cognitive functions and mental health in patients with a degree of disability no more… Read more about this study
- Who is it for?
- Ages 30 to 79 years
- Conditions the study is for
- Stroke, Motor Disorders, Affective Symptoms
- What is being tested?
- Training on VR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteRussia
- Study dates
- 1 Oct 2019to 27 Jul 2020
- 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 30 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- with a stroke, transferred at least 2 weeks ago; with no history of neurological or psychiatric disorders; able to maintain an upright posture and walk without support or with minimal support for at least 30 minutes; with stable hemodynamics;
Who cannot join
- not having epileptic activity; not having serious ophthalmic disorders; less than 24 scores in MoCA
Trial locations and contacts
1 site in 1 country.
Russia1 site
Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
Moscow, 117997
About this study
Official title: Virtual Reality Training Affects on Motor Functions and Mental Health in Stroke Patients: a Pilot Study
In our study, we tested the hypothesis of the safe effect applicability of motor training in the immersion high-tech polymodal VR system not only on the parameters of balance, gait, and motor status of the patient, but also on his cognitive functions and mental health in patients with a degree of disability no more than 3 points on a scale Rankin.
Read the detailed description
The neurological consequences of stroke cover the motor, sensory, visual, affective, cognitive and speech spheres. 55-75% of stroke survivors suffer from motor impairments, caused, inter alia, by hemiparesis, which substantially reduce the quality of their life. In addition, neurocognitive functions, especially memory, visual-constructive abilities and executive functions, are often affected by stroke. Cognitive impairments appear in 83% patients in at least one cognitive domain, whereas in 50% patients appear in multiple (≥3) domains. These disorders affect the quality of life of patients, their skills of daily activity (the ability to go to the store, prepare food, plan their actions for organizing a daily routine), social adaptation. One of the rehabilitation methods that are comprehensively suitable for the recovering on of stroke consequences is the intervention using virtual reality. The VR method is used for the rehabilitation of stroke patients with various motor and neurocognitive deficits: one-sided spatial ignorance, disorders of attention, memory, mood, visual-spatial functions, and constructive abilities.
In our study, we tested the hypothesis of the applicability of the safe effect of motor training in the immersion high-tech polymodal VR system not only on the parameters of balance, gait, and motor status of the patient, but also on his cognitive functions and mental health in patients with a degree of disability no more than 3 score on a modified Rankin Scale.
Stroke patients participated in the study in Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health in Moscow, Russia. The study was run between October 2019 and July 2020 and was approved by a local ethic committee and followed principles of the Declaration of Helsinki. The patients stayed in a 24-hour hospital and underwent a rehabilitation course. This course included a VR Trainig of 10 sessions of 40 minutes each, which the patients took over two weeks. VR training was conducted on the GRAIL system equipment (Motekforce, Netherlands), consisting of a semi-cylindrical screen, treadmill, 10 infrared cameras (Vicon, UK) and reflective markers, and software providing biofeedback in real time. For complex recovery in VR, exercises stimulate the motor, cognitive and behavioral spheres, including visual-spatial orientation, the process of attention (with one and duai-task), executive functions, lowering the level of anxiety, hand-eye coordination and balance.Training applications were based on the therapeutic goals for every patient, according to postural stability and gait adaptation.
Before and after the end of the training, the patient's condition was assessed, including measurements in motor and daily living activity, measurements in mental health, measurements in Virtual Reality.
- Being tested
- Training on VR
- Keywords
- Stroke, Virtual reality, Rehabilitation, Motion capture
- Medical subject headings
- Stroke, Motor Disorders, Affective Symptoms, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training on VROther
The training is aimed at improving the functioning of the motor sphere, including balance, gait, and upper limb function, as well as increasing the level of motivation and reducing the level of anxiety and depression. Game applications were selected based on therapeutic tasks of motor recovery.
| Study group | Role | What they receive |
|---|---|---|
| Training Group | Experimental | Training Group recieved 10 sessions on VR (Grail Motekforce, Netherlands) during two weeks. One session lasted 40 minuties. Receives: Other: Training on VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural stability test (Grail Motekforce)
The subject's ability to remain balanced under four different conditions is evaluated (cm/s).
Measured: Change from baseline at 2 weeks
Six-minute walk test (6MWT) (Grail Motekforce)
The 6-minute walk test evaluates how much distance a subject can cover in six minutes (m).
Measured: Change from baseline at 2 weeks
Beck Depression Inventory
Measures the severity of depression (0-63; 30-63 scores indicate severe depression)
Measured: Change from baseline at 2 weeks
State-Trait Anxiety Inventory
Examines two types of anxiety - state anxiety (anxiety about an event) and trait anxiety (anxiety level as a personal characteristic) with the score range from 20 to 80, where higher scores correspond to greater anxiety
Measured: Change from baseline at 2 weeks
Secondary outcomes (6)
Standing Balance Test
Examines the patient's ability to maintain an upright position (0-4, where 0 - can't stand)
Measured: Change from baseline at 2 weeks
Berg Balance Scale
Relates to evaluation of static and dynamic balance, consists of 14 tasks, ranging from standing up from a sitting position, to standing on one foot
Measured: Change from baseline at 2 weeks
Timed Up and Go Test
Examines functional mobility and requires a patient to stand up, walk 3 meters, turn, walk back, and sit down; result is obtained in seconds
Measured: Change from baseline at 2 weeks
Hauser Ambulation Index
Assess mobility by evaluating the time and degree of assistance required to walk a 8-m distance as quickly and safely as possible, with scores that range from 0 (asymptomatic) to 10 (bedridden)
Measured: Change from baseline at 2 weeks
Rivermead Activities of Daily Living Scales
Assesses self-service and two types of domestic activities, maximum scores (90) indicate independence in daily living activity
Measured: Change from baseline at 2 weeks
Functional Independence Measure
Examines the functional status of the patient in 18 domains related to cognitive and motor functions up to the maximum in 126 scores (independence in daily life)
Measured: Change from baseline at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start1 Oct 2019
- Primary completion27 Jul 2020
- Study completion27 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marina A Shurupova, Principal investigator, Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of HealthAlina D Aizenshtein, Principal investigator, Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of HealthGalina Ivanova, Prof., Study chair, Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of HealthNadezhda L Cherepahina, PhD, Principal investigator, Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04681235
- Sponsor's protocol ID
- VR001
- Status last verified
- Dec 2020
- First submitted
- 18 Dec 2020
- Last updated
- 23 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Training Affects on Motor Functions and Mental Health in Stroke Patients: a Pilot Study
- ClinicalTrials.gov ID
- NCT04681235
- Acronym / sponsor ID
- VR001
- Keywords
- Stroke, Virtual reality, Rehabilitation, Motion capture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of HealthUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 27 Jul 2020 (actual)
- Study completion
- 27 Jul 2020 (actual)
- First posted
- 23 Dec 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.
In our study, we tested the hypothesis of the safe effect applicability of motor training in the immersion high-tech polymodal VR system not only on the parameters of balance, gait, and motor status of the patient, but also on his cognitive functions and mental health in patients with a degree of disability no more than 3 points on a scale Rankin.
Detailed description
The neurological consequences of stroke cover the motor, sensory, visual, affective, cognitive and speech spheres. 55-75% of stroke survivors suffer from motor impairments, caused, inter alia, by hemiparesis, which substantially reduce the quality of their life. In addition, neurocognitive functions, especially memory, visual-constructive abilities and executive functions, are often affected by stroke. Cognitive impairments appear in 83% patients in at least one cognitive domain, whereas in 50% patients appear in multiple (≥3) domains. These disorders affect the quality of life of patients, their skills of daily activity (the ability to go to the store, prepare food, plan their actions for organizing a daily routine), social adaptation. One of the rehabilitation methods that are comprehensively suitable for the recovering on of stroke consequences is the intervention using virtual reality. The VR method is used for the rehabilitation of stroke patients with various motor and neurocognitive deficits: one-sided spatial ignorance, disorders of attention, memory, mood, visual-spatial functions, and constructive abilities.
In our study, we tested the hypothesis of the applicability of the safe effect of motor training in the immersion high-tech polymodal VR system not only on the parameters of balance, gait, and motor status of the patient, but also on his cognitive functions and mental health in patients with a degree of disability no more than 3 score on a modified Rankin Scale.
Stroke patients participated in the study in Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health in Moscow, Russia. The study was run between October 2019 and July 2020 and was approved by a local ethic committee and followed principles of the Declaration of Helsinki. The patients stayed in a 24-hour hospital and underwent a rehabilitation course. This course included a VR Trainig of 10 sessions of 40 minutes each, which the patients took over two weeks. VR training was conducted on the GRAIL system equipment (Motekforce, Netherlands), consisting of a semi-cylindrical screen, treadmill, 10 infrared cameras (Vicon, UK) and reflective markers, and software providing biofeedback in real time. For complex recovery in VR, exercises stimulate the motor, cognitive and behavioral spheres, including visual-spatial orientation, the process of attention (with one and duai-task), executive functions, lowering the level of anxiety, hand-eye coordination and balance.Training applications were based on the therapeutic goals for every patient, according to postural stability and gait adaptation.
Before and after the end of the training, the patient's condition was assessed, including measurements in motor and daily living activity, measurements in mental health, measurements in Virtual Reality.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Training Group | Experimental | Other: Training on VRTraining Group recieved 10 sessions on VR (Grail Motekforce, Netherlands) during two weeks. One session lasted 40 minuties. |
Who may qualify
- Ages
- 30 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- with a stroke, transferred at least 2 weeks ago; with no history of neurological or psychiatric disorders; able to maintain an upright posture and walk without support or with minimal support for at least 30 minutes; with stable hemodynamics;
Key exclusion criteria (1 listed)
- not having epileptic activity; not having serious ophthalmic disorders; less than 24 scores in MoCA
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 |
|---|---|---|
| Training on VRThe training is aimed at improving the functioning of the motor sphere, including balance, gait, and upper limb function, as well as increasing the level of motivation and reducing the level of anxiety and depression. Game applications were selected based on therapeutic tasks of motor recovery. | Other | Training Group |
Primary outcome
Postural stability test (Grail Motekforce)
Time frame: Change from baseline at 2 weeks
The subject's ability to remain balanced under four different conditions is evaluated (cm/s).
Six-minute walk test (6MWT) (Grail Motekforce)
Time frame: Change from baseline at 2 weeks
The 6-minute walk test evaluates how much distance a subject can cover in six minutes (m).
Beck Depression Inventory
Time frame: Change from baseline at 2 weeks
Measures the severity of depression (0-63; 30-63 scores indicate severe depression)
State-Trait Anxiety Inventory
Time frame: Change from baseline at 2 weeks
Examines two types of anxiety - state anxiety (anxiety about an event) and trait anxiety (anxiety level as a personal characteristic) with the score range from 20 to 80, where higher scores correspond to greater anxiety
6 secondary outcomes
Standing Balance Test
Time frame: Change from baseline at 2 weeks
Berg Balance Scale
Time frame: Change from baseline at 2 weeks
Timed Up and Go Test
Time frame: Change from baseline at 2 weeks
Hauser Ambulation Index
Time frame: Change from baseline at 2 weeks
Rivermead Activities of Daily Living Scales
Time frame: Change from baseline at 2 weeks
Functional Independence Measure
Time frame: Change from baseline at 2 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 23 Dec 2020.
- Individual participant dataSharing planned: No
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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.
Marina A Shurupova principal investigator
Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
Alina D Aizenshtein principal investigator
Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
Galina Ivanova, Prof. study chair
Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training on VR in people with Stroke and Motor Disorders, run by Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health 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 1 inclusion and 1 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 23 Dec 2020. 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?
Postural stability test (Grail Motekforce) (time frame: Change from baseline at 2 weeks). The study lists 4 primary outcomes in all. 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 23 Dec 2020.