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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Russian Federation
Russian center of Neurology and Neurosciences
RECRUITING
Moscow
Contact Information
Primary
Roman Kh Lyukmanov, PhD
xarisovich@gmail.com
+74953747776
Backup
Olesya Al Mokienko, PhD
o.mokienko@ihna.ru
+74953747776
Time Frame
Start Date: 2024-10-05
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 30
Treatments
Experimental: BCI
Stroke patients receiving NIRS-BCI-pneumoorthesis training in combination with standard therapy
No_intervention: Control
Stroke patients receiving standard therapy
Related Therapeutic Areas
Sponsors
Collaborators: Pirogov Russian National Research Medical University, Institute of Higher Nervous Activity and Neurophysiology of RAS
Leads: Research Center of Neurology, Russia

This content was sourced from clinicaltrials.gov