About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Severe cognitive impairments preventing instruction compliance
Sensory or severe motor aphasia
Severe visual impairments
Lower limb contractures
Trial design
Parallel
Treatments tested in this trial
NIRS-BCI-pneumoorthesis
DevicePatients 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
Treatment groups
Trial outcomes
Primary outcomes
Walking speed change as assessed by the 10-Meter Walk Test
Before and after treatment course
Lower extremity functional improvement as assessed by the Fugl-Meyer Assessment
Before and after treatment course
Secondary outcomes
Lower extremity functional improvement as assessed by the Timed Up and GO test
Before and after treatment course
Cognitive function improvement as assessed by the Addenbrooke's cognitive examination - III
Before and after treatment course
Other outcomes
Emotional improvement as assessed by the Hospital Anxiety and Depression Scale
Before and after treatment course
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Research Center of Neurology, Russia
Lead sponsor
Pirogov Russian National Research Medical University
Collaborator
Institute of Higher Nervous Activity and Neurophysiology of RAS
Collaborator