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| Name | Class |
|---|---|
| Pirogov Russian National Research Medical University | OTHER |
| Institute of Higher Nervous Activity and Neurophysiology of RAS | UNKNOWN |
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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.
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:
Cognitive Functions and Emotional State:
The study aims to confirm the effectiveness of NIRS-BCI combined with plantar support load simulator for:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BCI | Experimental | Stroke patients receiving NIRS-BCI-pneumoorthesis training in combination with standard therapy |
|
| Control | No Intervention | Stroke patients receiving standard therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIRS-BCI-pneumoorthesis | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Walking speed change as assessed by the 10-Meter Walk Test | Before and after treatment course | 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 | From enrollment to the end of treatment at 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Lower extremity functional improvement as assessed by the Timed Up and GO test | Before and after treatment course | From enrollment to the end of treatment at 2 weeks |
| Cognitive function improvement as assessed by the Addenbrooke's cognitive examination - III |
| Measure | Description | Time Frame |
|---|---|---|
| Emotional improvement as assessed by the Hospital Anxiety and Depression Scale | Before and after treatment course | From enrollment to the end of treatment at 2 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roman Kh Lyukmanov, PhD | Contact | +74953747776 | xarisovich@gmail.com | |
| Olesya Al Mokienko, PhD | Contact | +74953747776 | o.mokienko@ihna.ru |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Russian center of Neurology and Neurosciences | Recruiting | Moscow | 117485 | Russia |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
Before and after treatment course |
| "From enrollment to the end of treatment at 2 weeks |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |