Brain-computer Interface With Plantar Pneumoorthoses for Post-stroke Rehabilitation

Official title

Clinical Evaluation of a Brain-computer Interface Integrated With Plantar Pneumoorthoses for Motor and Cognitive Rehabilitation in Stroke Survivors

Overview

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

Interventions

• Device 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)

Primary outcome measures

• Walking speed change as assessed by the 10-Meter Walk Test [Time frame: From enrollment to the end of treatment at 2 weeks]
• Lower extremity functional improvement as assessed by the Fugl-Meyer Assessment [Time frame: From enrollment to the end of treatment at 2 weeks]

Secondary outcome measures (2)

• 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]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• Severe cognitive impairments preventing instruction compliance
• Sensory or severe motor aphasia
• Severe visual impairments
• Lower limb contractures
• Inability to maintain sitting position

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Russia · 1 center

• Russian center of Neurology and Neurosciences — Moscow

Identifiers

NCT: NCT07081308 · NIRS-BCI-Korvit

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗