Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT07081308

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

Led by Research Center of Neurology, Russia · Updated on 2025-07-28

30

Participants Needed

1

Research Sites

116 weeks

Total Duration

On this page

Sponsors

R

Research Center of Neurology, Russia

Lead Sponsor

P

Pirogov Russian National Research Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 80 years
  • Primary or recurrent supratentorial ischemic stroke
  • Stroke occurred between 7 days and 24 months ago
  • Moderate to mild lower limb motor impairments after stroke
  • Clinically stable condition
  • Voluntary participation with signed informed consent
Not Eligible

You will not qualify if you...

  • Severe cognitive impairment preventing following instructions
  • Sensory or severe motor aphasia
  • Severe visual impairments
  • Lower limb contractures
  • Unable to maintain sitting position

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Russian center of Neurology and Neurosciences

Moscow, Russia, 117485

Actively Recruiting

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Research Team

R

Roman Kh Lyukmanov, PhD

CONTACT

O

Olesya Al Mokienko, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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