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

Официальное название

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

Обзор

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.

Подробное описание

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

Вмешательства

• Устройство 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)

Первичные конечные точки

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

Вторичные конечные точки (2)

• Lower extremity functional improvement as assessed by the Timed Up and GO test [Срок оценки: From enrollment to the end of treatment at 2 weeks]
• Cognitive function improvement as assessed by the Addenbrooke's cognitive examination - III [Срок оценки: "From enrollment to the end of treatment at 2 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Россия · 1 центр

• Russian center of Neurology and Neurosciences — Moscow

Идентификаторы

NCT: NCT07081308 · NIRS-BCI-Korvit

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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