Brain-computer Interface With Plantar Pneumoorthoses for Post-stroke Rehabilitation
NCT ID: NCT07081308
Last Updated: 2025-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
30 participants
INTERVENTIONAL
2024-10-05
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Neuromechanical Mechanisms of Exosuit-assisted Gait Rehabilitation After Stroke
NCT07218094
Effects of Soft Robotic Exosuit on Exercise Capacity, Biomakers of Neuroplasticity, and Motor Learning After Stroke
NCT05138016
Personalized Post-Stroke Gait Rehabilitation Interventions
NCT07212608
Ankle Exoskeleton for Stroke Gait Enhancement
NCT07179627
Locomotor Recovery and Compensation Post-stroke (LRC)
NCT05081713
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BCI
Stroke patients receiving NIRS-BCI-pneumoorthesis training in combination with standard therapy
NIRS-BCI-pneumoorthesis
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
Control
Stroke patients receiving standard therapy
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
NIRS-BCI-pneumoorthesis
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* Sensory or severe motor aphasia
* Severe visual impairments
* Lower limb contractures
* Inability to maintain sitting position
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pirogov Russian National Research Medical University
OTHER
Institute of Higher Nervous Activity and Neurophysiology of RAS
UNKNOWN
Research Center of Neurology, Russia
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Natalia Suponeva
Director of Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Russian center of Neurology and Neurosciences
Moscow, , Russia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NIRS-BCI-Korvit
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.