StrokeBRAIN-WALKNCT07081308
Brain-computer Interface With Plantar Pneumoorthoses for Post-stroke Rehabilitation
A study testing NIRS-BCI-pneumoorthesis in people with Stroke, run by Research Center of Neurology, Russia at 1 site in Russia.
Trial summary
STUDY PURPOSE The investigators are testing a new rehabilitation system that helps stroke patients recover their ability to walk and think more clearly. This system, called brain-computer interface with plantar pneumorthoses, uses brain signals to control a special device that provides gentle pressure to the feet… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- NIRS-BCI-pneumoorthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteRussia
- Study dates
- 5 Oct 2024to 31 Dec 2026
- 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
- Age 18-80 years
- Primary or recurrent supratentorial ischemic stroke
- Stroke onset 7 days to 24 months
- Moderate to mild post-stroke lower limb motor impairments
- Clinical stability
- Voluntary participation and signing of informed consent
Who cannot join
- Severe cognitive impairments preventing instruction compliance
- Sensory or severe motor aphasia
- Severe visual impairments
- Lower limb contractures
- Inability to maintain sitting position
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Russian center of Neurology and Neurosciences
Moscow, 117485
Roman Kh Lyukmanov, PhD, 4953747776, xarisovich@gmail.com
Olesya Al Mokienko, PhD, +74953747776, o.mokienko@ihna.ru
About this study
Official title: Clinical Evaluation of a Brain-computer Interface Integrated With Plantar Pneumoorthoses for Motor and Cognitive Rehabilitation in Stroke Survivors
STUDY PURPOSE The investigators are testing a new rehabilitation system that helps stroke patients recover their ability to walk and think more clearly. This system, called brain-computer interface with plantar pneumorthoses, uses brain signals to control a special device that provides gentle pressure to the feet, similar to what you feel when walking. The goal is to help patients regain walking skills, improve memory and thinking, and feel better emotionally.
STUDY QUESTIONS
Read more
The main questions the study aims to answer are:
Whether the investigated technology can improve walking in post-stroke patients? Whether the training to control the technology can improve cognitive function in post-stroke patients?
HOW THE STUDY WORKS The investigators compare two groups - one using the new system, another group receiving standard rehabilitation therapy.
Up to 15 patients will try the new system: 10 sessions, each lasting 12 minutes (about 2 weeks, Monday-Friday).
WHAT HAPPENS DURING TREATMENT?
The equipment includes:
Brain monitoring device: Safe infrared light sensors placed on the patient's head (like a cap) Computer software: Reads brain signals when the patient thinks about walking Foot device: Special pneumatic shoes that provide gentle pressure to the patient's feet Screen: Shows visual feedback during training.
What the patient will do:
Sit comfortably in a chair with special shoes on their feet, Complete the task: imagine walking or relax when instructed, What the patient will experience: They will see colors change on the screen and feel gentle pressure on their feet.
Read the detailed description
INTERVENTION NIRS-BCI-Korvit System Components: NIRScout hardware-software complex (16 light sources, 8 detectors); Software for brain activity classification; Korvit pneumoorthesis for plantar support load reproduction; 22-inch monitor for task demonstration Training Procedure: Patient seated with lower limbs fixed in pneumatic orthoses; Task: kinesthetically imagine walking or relax; Feedback: visual (color change on screen) and tactile (support load through orthosis).
Training structure: 16 blocks alternating walking imagination and relaxation/ ASSESSMENT
Motor Function:
- Fugl-Meyer Scale for Lower Extremity (maximum 34 points, clinically significant improvement ≥6 points);
- 10-meter Walk Test (clinically significant improvement ≥0.16 m/s);
- Timed Up and Go Test (clinically significant improvement ≥3 seconds).
Cognitive Functions and Emotional State:
- Addenbrooke's Cognitive Examination III (ACE III);
- Hospital Anxiety and Depression Scale (HADS). EXPECTED OUTCOMES.
The study aims to confirm the effectiveness of NIRS-BCI combined with plantar support load simulator for:
- Gait restoration;
- Cognitive function improvement;
- Emotional state normalization in post-stroke patients SAFETY The procedure is safe and poses no health risks. Possible minor fatigue after sessions. The study can be discontinued at any stage upon patient request or if adverse effects occur.
INNOVATION This research represents a novel approach combining non-invasive brain-computer interface technology with proprioceptive feedback systems for comprehensive post-stroke rehabilitation, addressing both motor and cognitive recovery simultaneously
- Conditions
- Stroke
- Being tested
- NIRS-BCI-pneumoorthesis
- Keywords
- Brain-computer interface, Near infrared spectroscopy, gait recovery, stroke rehabilitation, Neurobiofeedback
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRS-BCI-pneumoorthesisDevice
Also called neurobiofeedback
Patients recieve 10 NIRS-BCI-pneumoorthesis trainings of 16 minutes each over 2 weeks.
NIRS-BCI-pneumoorthesis Components: NIRScout hardware-software complex (16 light sources, 8 detectors); Software for brain activity classification; Korvit system for plantar support load reproduction; 22-inch monitor for task demonstration.
Training Procedure: Patient seated with lower limbs fixed in pneumatic orthoses; Task: kinesthetically imagine walking or relax; Feedback: visual (color change on screen) and tactile (support load through orthosis).
Training structure: 16 blocks alternating walking imagination and relaxation
| Study group | Role | What they receive |
|---|---|---|
| BCI | Experimental | Stroke patients receiving NIRS-BCI-pneumoorthesis training in combination with standard therapy Receives: Device: NIRS-BCI-pneumoorthesis |
| Control | No intervention | Stroke patients receiving standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking speed change as assessed by the 10-Meter Walk Test
Before and after treatment course
Measured: From enrollment to the end of treatment at 2 weeks
Lower extremity functional improvement as assessed by the Fugl-Meyer Assessment
Before and after treatment course
Measured: From enrollment to the end of treatment at 2 weeks
Secondary outcomes (2)
Lower extremity functional improvement as assessed by the Timed Up and GO test
Before and after treatment course
Measured: From enrollment to the end of treatment at 2 weeks
Cognitive function improvement as assessed by the Addenbrooke's cognitive examination - III
Before and after treatment course
Measured: "From enrollment to the end of treatment 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 Jul 2025
- Study start5 Oct 2024
- Primary completion30 Oct 2026 (estimated)
- Study completion31 Dec 2026 (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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research Center of Neurology, Russia
- Sponsor type
- Other government
- Collaborators
- Pirogov Russian National Research Medical University, Institute of Higher Nervous Activity and Neurophysiology of RAS
- Responsible party
- Principal investigator, Natalia Suponeva, Research Center of Neurology, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07081308
- Sponsor's protocol ID
- NIRS-BCI-Korvit
- Acronym
- BRAIN-WALK
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 28 Jul 2025
- 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 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a Brain-computer Interface Integrated With Plantar Pneumoorthoses for Motor and Cognitive Rehabilitation in Stroke Survivors
- ClinicalTrials.gov ID
- NCT07081308
- Acronym / sponsor ID
- BRAIN-WALK / NIRS-BCI-Korvit
- Conditions
- Stroke
- Keywords
- Brain-computer interface, Near infrared spectroscopy, gait recovery, stroke rehabilitation, Neurobiofeedback
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Research Center of Neurology, RussiaOther government
- Collaborators
- Pirogov Russian National Research Medical University, Institute of Higher Nervous Activity and Neurophysiology of RAS
- Study start
- 5 Oct 2024 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Jul 2025 (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.
STUDY PURPOSE The investigators are testing a new rehabilitation system that helps stroke patients recover their ability to walk and think more clearly. This system, called brain-computer interface with plantar pneumorthoses, uses brain signals to control a special device that provides gentle pressure to the feet, similar to what you feel when walking. The goal is to help patients regain walking skills, improve memory and thinking, and feel better emotionally.
STUDY QUESTIONS
The main questions the study aims to answer are:
Whether the investigated technology can improve walking in post-stroke patients? Whether the training to control the technology can improve cognitive function in post-stroke patients?
HOW THE STUDY WORKS The investigators compare two groups - one using the new system, another group receiving standard rehabilitation therapy.
Up to 15 patients will try the new system: 10 sessions, each lasting 12 minutes (about 2 weeks, Monday-Friday).
WHAT HAPPENS DURING TREATMENT?
The equipment includes:
Brain monitoring device: Safe infrared light sensors placed on the patient's head (like a cap) Computer software: Reads brain signals when the patient thinks about walking Foot device: Special pneumatic shoes that provide gentle pressure to the patient's feet Screen: Shows visual feedback during training.
What the patient will do:
Sit comfortably in a chair with special shoes on their feet, Complete the task: imagine walking or relax when instructed, What the patient will experience: They will see colors change on the screen and feel gentle pressure on their feet.
Detailed description
INTERVENTION NIRS-BCI-Korvit System Components: NIRScout hardware-software complex (16 light sources, 8 detectors); Software for brain activity classification; Korvit pneumoorthesis for plantar support load reproduction; 22-inch monitor for task demonstration Training Procedure: Patient seated with lower limbs fixed in pneumatic orthoses; Task: kinesthetically imagine walking or relax; Feedback: visual (color change on screen) and tactile (support load through orthosis).
Training structure: 16 blocks alternating walking imagination and relaxation/ ASSESSMENT
Motor Function:
- Fugl-Meyer Scale for Lower Extremity (maximum 34 points, clinically significant improvement ≥6 points);
- 10-meter Walk Test (clinically significant improvement ≥0.16 m/s);
- Timed Up and Go Test (clinically significant improvement ≥3 seconds).
Cognitive Functions and Emotional State:
- Addenbrooke's Cognitive Examination III (ACE III);
- Hospital Anxiety and Depression Scale (HADS). EXPECTED OUTCOMES.
The study aims to confirm the effectiveness of NIRS-BCI combined with plantar support load simulator for:
- Gait restoration;
- Cognitive function improvement;
- Emotional state normalization in post-stroke patients SAFETY The procedure is safe and poses no health risks. Possible minor fatigue after sessions. The study can be discontinued at any stage upon patient request or if adverse effects occur.
INNOVATION This research represents a novel approach combining non-invasive brain-computer interface technology with proprioceptive feedback systems for comprehensive post-stroke rehabilitation, addressing both motor and cognitive recovery simultaneously
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCI | Experimental | Device: NIRS-BCI-pneumoorthesisStroke patients receiving NIRS-BCI-pneumoorthesis training in combination with standard therapy |
| Control | No intervention | –Stroke patients receiving standard therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-80 years
- Primary or recurrent supratentorial ischemic stroke
- Stroke onset 7 days to 24 months
- Moderate to mild post-stroke lower limb motor impairments
- Clinical stability
Key exclusion criteria (5 listed)
- Severe cognitive impairments preventing instruction compliance
- Sensory or severe motor aphasia
- Severe visual impairments
- Lower limb contractures
- Inability to maintain sitting position
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 |
|---|---|---|
| NIRS-BCI-pneumoorthesisAlso: neurobiofeedbackPatients recieve 10 NIRS-BCI-pneumoorthesis trainings of 16 minutes each over 2 weeks. NIRS-BCI-pneumoorthesis Components: NIRScout hardware-software complex (16 light sources, 8 detectors); Software for brain activity classification; Korvit system for plantar support load reproduction; 22-inch monitor for task demonstration. Training Procedure: Patient seated with lower limbs fixed in pneumatic orthoses; Task: kinesthetically imagine walking or relax; Feedback: visual (color change on screen) and tactile (support load through orthosis). Training structure: 16 blocks alternating walking imagination and relaxation | Device | BCI |
Primary outcome
Walking speed change as assessed by the 10-Meter Walk Test
Time frame: From enrollment to the end of treatment at 2 weeks
Before and after treatment course
Lower extremity functional improvement as assessed by the Fugl-Meyer Assessment
Time frame: From enrollment to the end of treatment at 2 weeks
Before and after treatment course
2 secondary outcomes
Lower extremity functional improvement as assessed by the Timed Up and GO test
Time frame: From enrollment to the end of treatment at 2 weeks
Cognitive function improvement as assessed by the Addenbrooke's cognitive examination - III
Time frame: "From enrollment to the end of treatment at 2 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 28 Jul 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIRS-BCI-pneumoorthesis in people with Stroke, run by Research Center of Neurology, 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 6 inclusion and 5 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 28 Jul 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 Roman Kh Lyukmanov, PhD (+74953747776, xarisovich@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking speed change as assessed by the 10-Meter Walk Test (time frame: From enrollment to the end of treatment at 2 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 28 Jul 2025.