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

ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorResearch Center of Neurology, Russia

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Severe cognitive impairments preventing instruction compliance

Sensory or severe motor aphasia

Severe visual impairments

Lower limb contractures

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: BCIExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Walking speed change as assessed by the 10-Meter Walk Test

Before and after treatment course

Time frame
From enrollment to the end of treatment at 2 weeks
2

Lower extremity functional improvement as assessed by the Fugl-Meyer Assessment

Before and after treatment course

Time frame
From enrollment to the end of treatment at 2 weeks

Secondary outcomes

1

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

Before and after treatment course

Time frame
From enrollment to the end of treatment at 2 weeks
2

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

Before and after treatment course

Time frame
"From enrollment to the end of treatment at 2 weeks

Other outcomes

1

Emotional improvement as assessed by the Hospital Anxiety and Depression Scale

Before and after treatment course

Time frame
From enrollment to the end of treatment at 2 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Research Center of Neurology, Russia

Lead sponsor

Pirogov Russian National Research Medical University

Collaborator

Institute of Higher Nervous Activity and Neurophysiology of RAS

Collaborator