StrokeNCT06753006
Research on the Effectiveness of Neurorehabilitation After Stroke
A study testing Neurorehabilitation simulator and Standard course in people with Stroke and Stroke Acute, run by Neurotechnika at 1 site in Russia.
Trial summary
This clinical trial aims to investigate the effectiveness of a novel neurorehabilitation technology for treating stroke in adults. The study will evaluate a simulator that combines robotic orthosis, a non-invasive brain-computer interface (BCI), and a virtual reality (VR) display. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Stroke Acute, Stroke with Hemiparesis
- What is being tested?
- Neurorehabilitation simulator and Standard course
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteRussia
- Study dates
- 27 Aug 2024to Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent.
- Age 18 to 80 years at the time of stroke onset.
- Early rehabilitation period (up to 6 months post-stroke).
- Diagnosis of acute cerebrovascular accident confirmed by MRI or CT.
- Upper limb paresis severity between 0 and 3 on the 6-point Medical Research Council (MRC) muscle strength scale.
- Ability and willingness to comply with the study protocol.
- Demonstrated motivation for rehabilitation.
Who cannot join
- Montreal Cognitive Assessment scale (MoCA) score less than 10 points.
- Hamilton Depression Rating Scale (Ham-D) score greater than 18 points.
- Modified Rankin Scale (mRS) score greater than 4 points.
- Pre-existing conditions that cause decreased muscle strength or increased muscle tone in the upper limbs (e.g., cerebral palsy, traumatic brain injury) or rigidity (e.g., Parkinson's disease, contractures).
- Advanced arthritis or significant limitation of upper limb range of motion.
- Absence of part of the upper limb due to amputation for any reason.
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- Any medical condition that may affect the conduct of the study or patient safety (e.g., mental illness).
- Alcohol abuse or recreational drug use within the 12 months preceding the study.
- Use of experimental medications or medical devices within the 30 days preceding the study.
- Inability to comply with research procedures, as determined by the researcher.
- The severity of the patient's condition, based on neurological or physical status, does not permit full rehabilitation.
- Visual acuity less than 0.2 in the weakest eye according to the Sivtsev visual acuity chart.
- Unstable angina and/or heart attack within the 30 days preceding the study.
- Recurrent stroke.
- Uncontrolled arterial hypertension.
- Ataxia.
- Presence of a pacemaker and/or other implanted electronic devices.
- Use of muscle relaxants.
- Peripheral neuropathy.
- Coexisting diseases in an exacerbation or decompensated stage requiring active treatment.
- Allergic reactions or other skin lesions at the EEG electrode application sites at the time of the study.
- Acute urinary tract infections.
- Acute thrombophlebitis.
- Any form of epilepsy.
- Benign and malignant neoplasms.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alexander Zakharov, Ph.D. contact
Russia1 site, 1 recruiting
- Recruiting
Samara Regional Clinical Hospital named after V.D. Seredavin
Samara, Samara Oblast, 443095
Alexander Zakharov, Ph.D., +79171620301, a.v.zaharov@samsmu.ru
Alexander Zakharov, Ph.D.
About this study
Official title: A Study of Neurorehabilitation Based on Robotics, Brain-Computer Interface (BCI) and Virtual Reality (VR) in Patients with Upper Limb Paresis Due to Stroke in the Early Rehabilitation Period
This clinical trial aims to investigate the effectiveness of a novel neurorehabilitation technology for treating stroke in adults. The study will evaluate a simulator that combines robotic orthosis, a non-invasive brain-computer interface (BCI), and a virtual reality (VR) display. The goal of this trial is to advance stroke rehabilitation by exploring the potential benefits of these cutting-edge technologies.
Key Research Questions:
Read more
Efficacy: Does the new simulator significantly improve arm function compared to standard rehabilitation techniques?
BCI Technology: Which approach - motor imagery of only the paretic arm or both the paretic and healthy arm - yields greater functional improvements?
VR Contribution: How does the integration of VR enhance rehabilitation outcomes?
Safety and Tolerability: What potential side effects or adverse events may arise from using the new simulator?
Participants who have suffered a stroke will undergo a standard rehabilitation course, during which 10-12 sessions will take place using the innovative simulator: a robotic device moves a patient's paralyzed arm at the command of a non-invasive brain-computer interface to perform a game task resembling real-life activities, augmented by a virtual reality display.
Researchers will assess the impact of the new technology on arm function to determine its efficacy in promoting recovery.
- Conditions
- Stroke, Stroke Acute, Stroke with Hemiparesis, Stroke, Acute, Stroke, Acute, Ischemic, Stroke, Ischemic
- Being tested
- Neurorehabilitation simulator, Standard course
- Keywords
- Stroke, Rehabilitation, Brain-Computer Interface, Motor Imagery, Robotics, Virtual Reality, Neurofeedback
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurorehabilitation simulatorDevice
The participant must complete a mental task - imagine the movement of his arm. If successful, the robotic simulator moves the paralyzed limb.
Standard courseProcedure or surgery
The participant receives a standard course of intervention as prescribed by the attending physician in accordance
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | The Control group receives a standard course of intervention (14-21 days) as prescribed by the attending physician, in accordance with the standards of the Ministry of Health of the Russian Federation for the provision of medical care to people who have suffered a stroke. Receives: Procedure: Standard course |
| MI+VR | Experimental | In addition to the standard course of intervention, the MI+VR group undergoes 10-12 sessions using a novel simulator involving the paretic arm with immersion in virtual reality. Receives: Device: Neurorehabilitation simulator; Procedure: Standard course |
| MI2+VR | Experimental | In addition to the standard course of intervention, the MI2+VR group undergoes 10-12 sessions using a novel simulator involving both arms (healthy and paretic) with immersion in virtual reality. Receives: Device: Neurorehabilitation simulator; Procedure: Standard course |
| MI2 | Experimental | In addition to the standard course of intervention, the group MI2 undergoes 10-12 sessions using a novel simulator involving both arms (healthy and paretic) without immersion in virtual reality, using a computer display instead. Receives: Device: Neurorehabilitation simulator; Procedure: Standard course |
What is being measured
The primary outcome is the main question the study is designed to answer.
FMA-UE A-D
The Fugl-Meyer Assessment for Upper Extremity, parts A-D (FMA-UE A-D) evaluates a patient's motor function, with scores ranging from 0 (indicating the most severe impairment) to 66 (indicating no impairment). Details available at https://www.gu.se/en/neuroscience-physiology/fugl-meyer-assessment.
Measured: From enrollment to the end of treatment at 2-3 weeks
ARAT
The Action Research Arm Test (ARAT) evaluates a patient's ability to handle objects of various sizes, weights, and shapes, making it a specific measure of arm-related activity limitations. Scores range from 0 (indicating the most severe impairment) to 57 (indicating no impairment). Details available at https://strokengine.ca/en/assessments/action-research-arm-test-arat.
Measured: From enrollment to the end of treatment at 2-3 weeks
Secondary outcomes (5)
NIHSS
Dynamics according to the National Institutes of Health Stroke Scale (NIHSS) that assesses a stroke patient's neurological impairment and degree of recovery for patients with stroke in the range from 0 (no impairment) to 42 (very severe impairment). Details available at https://strokengine.ca/en/assessments/nihss.
Measured: From enrollment to the end of treatment at 2-3 weeks
Ashworth
Dynamics according to the Ashworth Spasticity Scale that assesses a patient's spasticity in the range from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension). Details available at https://www.sralab.org/rehabilitation-measures/ashworth-scale-modified-ashworth-scale.
Measured: From enrollment to the end of treatment at 2-3 weeks
RMI
Dynamics according to the Rivermead Mobility Index (RMI) that assesses a patient's functional abilities such as gait, balance, and transfers in the range from 0 (worst mobility performance) to 15 (best mobility performance). Details available at https://strokengine.ca/en/assessments/rivermead-mobility-index-rmi.
Measured: From enrollment to the end of treatment at 2-3 weeks
MRS
Dynamics according to the Modified Rankin Scale (MRS) that assesses a patient's level of functional independence in the range from 0 (no symptoms) to 5 (severe disability). Details available at https://strokengine.ca/en/assessments/modified-rankin-scale-mrs.
Measured: From enrollment to the end of treatment at 2-3 weeks
SF-36
The SF-36 is a multi-purpose survey designed to capture adult patients' perceptions of their own health and well-being. Scores range from 0 (maximum disability) to 100 (no disability). Details available at https://nexusipe.org/advancing/assessment-evaluation/short-form-sf-36-health-survey.
Measured: From enrollment to the end of treatment at 2-3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start27 Aug 2024
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either one of three experimental groups or a control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurotechnika
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Samara State Medical University, Samara Regional Clinical Hospital V.D. Seredavin
- Responsible party
- Sponsor
- Investigators
- Alexander Zakharov, Ph.D., Principal investigator, Samara State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753006
- Sponsor's protocol ID
- NT-STROKE-2024-09
- Status last verified
- Dec 2024
- First submitted
- 21 Dec 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only authorized members of the research team will have access to individual participant data (IPD). The research team will not share any IPD with third parties. However, de-identified demographic and clinical data-such as treatment details, baseline characteristics, and outcome measures-will be made publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Neurorehabilitation Based on Robotics, Brain-Computer Interface (BCI) and Virtual Reality (VR) in Patients with Upper Limb Paresis Due to Stroke in the Early Rehabilitation Period
- ClinicalTrials.gov ID
- NCT06753006
- Acronym / sponsor ID
- NT-STROKE-2024-09
- Conditions
- Stroke, Stroke Acute, Stroke with Hemiparesis, Stroke, Acute, Stroke, Acute, Ischemic, Stroke, Ischemic
- Keywords
- Stroke, Rehabilitation, Brain-Computer Interface, Motor Imagery, Robotics, Virtual Reality, Neurofeedback
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- NeurotechnikaIndustry (pharma, biotech, devices)
- Collaborators
- Samara State Medical University, Samara Regional Clinical Hospital V.D. Seredavin
- Study start
- 27 Aug 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 31 Dec 2024 (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.
This clinical trial aims to investigate the effectiveness of a novel neurorehabilitation technology for treating stroke in adults. The study will evaluate a simulator that combines robotic orthosis, a non-invasive brain-computer interface (BCI), and a virtual reality (VR) display. The goal of this trial is to advance stroke rehabilitation by exploring the potential benefits of these cutting-edge technologies.
Key Research Questions:
Efficacy: Does the new simulator significantly improve arm function compared to standard rehabilitation techniques?
BCI Technology: Which approach - motor imagery of only the paretic arm or both the paretic and healthy arm - yields greater functional improvements?
VR Contribution: How does the integration of VR enhance rehabilitation outcomes?
Safety and Tolerability: What potential side effects or adverse events may arise from using the new simulator?
Participants who have suffered a stroke will undergo a standard rehabilitation course, during which 10-12 sessions will take place using the innovative simulator: a robotic device moves a patient's paralyzed arm at the command of a non-invasive brain-computer interface to perform a game task resembling real-life activities, augmented by a virtual reality display.
Researchers will assess the impact of the new technology on arm function to determine its efficacy in promoting recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Participants will be randomly assigned to either one of three experimental groups or a control group.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: Standard courseThe Control group receives a standard course of intervention (14-21 days) as prescribed by the attending physician, in accordance with the standards of the Ministry of Health of the Russian Federation for the provision of medical care to people who have suffered a stroke. |
| MI+VR | Experimental | Device: Neurorehabilitation simulator, Procedure: Standard courseIn addition to the standard course of intervention, the MI+VR group undergoes 10-12 sessions using a novel simulator involving the paretic arm with immersion in virtual reality. |
| MI2+VR | Experimental | Device: Neurorehabilitation simulator, Procedure: Standard courseIn addition to the standard course of intervention, the MI2+VR group undergoes 10-12 sessions using a novel simulator involving both arms (healthy and paretic) with immersion in virtual reality. |
| MI2 | Experimental | Device: Neurorehabilitation simulator, Procedure: Standard courseIn addition to the standard course of intervention, the group MI2 undergoes 10-12 sessions using a novel simulator involving both arms (healthy and paretic) without immersion in virtual reality, using a computer display instead. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed written informed consent.
- Age 18 to 80 years at the time of stroke onset.
- Early rehabilitation period (up to 6 months post-stroke).
- Diagnosis of acute cerebrovascular accident confirmed by MRI or CT.
- Upper limb paresis severity between 0 and 3 on the 6-point Medical Research Council (MRC) muscle strength scale.
Key exclusion criteria (25 listed)
- Montreal Cognitive Assessment scale (MoCA) score less than 10 points.
- Hamilton Depression Rating Scale (Ham-D) score greater than 18 points.
- Modified Rankin Scale (mRS) score greater than 4 points.
- Pre-existing conditions that cause decreased muscle strength or increased muscle tone in the upper limbs (e.g., cerebral palsy, traumatic brain injury) or rigidity (e.g., Parkinson's disease, contractures).
- Advanced arthritis or significant limitation of upper limb range of motion.
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 |
|---|---|---|
| Neurorehabilitation simulatorThe participant must complete a mental task - imagine the movement of his arm. If successful, the robotic simulator moves the paralyzed limb. | Device | MI+VR, MI2, MI2+VR |
| Standard courseThe participant receives a standard course of intervention as prescribed by the attending physician in accordance | Procedure or surgery | Control, MI+VR, MI2, MI2+VR |
Primary outcome
FMA-UE A-D
Time frame: From enrollment to the end of treatment at 2-3 weeks
The Fugl-Meyer Assessment for Upper Extremity, parts A-D (FMA-UE A-D) evaluates a patient's motor function, with scores ranging from 0 (indicating the most severe impairment) to 66 (indicating no impairment). Details available at https://www.gu.se/en/neuroscience-physiology/fugl-meyer-assessment.
ARAT
Time frame: From enrollment to the end of treatment at 2-3 weeks
The Action Research Arm Test (ARAT) evaluates a patient's ability to handle objects of various sizes, weights, and shapes, making it a specific measure of arm-related activity limitations. Scores range from 0 (indicating the most severe impairment) to 57 (indicating no impairment). Details available at https://strokengine.ca/en/assessments/action-research-arm-test-arat.
5 secondary outcomes
NIHSS
Time frame: From enrollment to the end of treatment at 2-3 weeks
Ashworth
Time frame: From enrollment to the end of treatment at 2-3 weeks
RMI
Time frame: From enrollment to the end of treatment at 2-3 weeks
MRS
Time frame: From enrollment to the end of treatment at 2-3 weeks
SF-36
Time frame: From enrollment to the end of treatment at 2-3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
- Individual participant dataSharing planned: No. Only authorized members of the research team will have access to individual participant data (IPD). The research team will not share any IPD with third parties. However, de-identified demographic and clinical data-such as treatment details, baseline characteristics, and outcome measures-will be made publicly available.
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
Alexander Zakharov, Ph.D. contact
Alexander Zakharov, Ph.D. principal investigator
Samara State Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurorehabilitation simulator and Standard course in people with Stroke and Stroke Acute, run by Neurotechnika 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 7 inclusion and 25 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: looking for participants now, as of the sponsor's last update on 1 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vladimir Bulanov (+79272081176, vb@ntech.team), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FMA-UE A-D (time frame: From enrollment to the end of treatment at 2-3 weeks). The study lists 2 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 1 Jan 2025.