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

NCT07081308 | Recruiting

• 1 other identifier: NIRS-BCI-Korvit
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

Brain-computer interface; Near infrared spectroscopy; gait recovery; stroke rehabilitation; Neurobiofeedback

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Lower extremity functional improvement as assessed by the Timed Up and GO test

  From enrollment to the end of treatment at 2 weeks

• Cognitive function improvement as assessed by the Addenbrooke's cognitive examination - III

  "From enrollment to the end of treatment at 2 weeks

Other Outcomes (1)

• Emotional improvement as assessed by the Hospital Anxiety and Depression Scale

  From enrollment to the end of treatment at 2 weeks

Study Arms (2)

BCI

EXPERIMENTAL

Stroke patients receiving NIRS-BCI-pneumoorthesis training in combination with standard therapy

Device: NIRS-BCI-pneumoorthesis

Control

NO INTERVENTION

Stroke patients receiving standard therapy

Interventions

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

Also known as: neurobiofeedback

BCI

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Research Center of Neurology, Russia: lead
• Pirogov Russian National Research Medical University: collaborator
• Institute of Higher Nervous Activity and Neurophysiology of RAS: collaborator

Study Sites (1)

Russian center of Neurology and Neurosciences

Moscow, 117485, Russia

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Roman Kh Lyukmanov, PhD

CONTACT

+74953747776; xarisovich@gmail.com

Olesya Al Mokienko, PhD

CONTACT

+74953747776; o.mokienko@ihna.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Institute

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 23, 2025
• Study Start: October 5, 2024
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)