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NCT07081308Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 28 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
30 (estimated)
First submitted
8 Jul 2025
Start date
5 Oct 2024
Primary completion date
30 Oct 2026
Lead sponsor
Research Center of Neurology, Russia
Diseases
Stroke
NCT number
NCT07081308

What you commit to

  • Study type: Interventional
  • Planned participants: 30
  • From 5 Oct 2024 to the primary completion date, 30 Oct 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

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

Who the study is looking for

  • 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

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Russian center of Neurology and Neurosciences
Coordinator of this site? Confirm its status
MoscowRussiaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.