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NCT Number: NCT07081308

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

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Russian center of Neurology and Neurosciences

Moscow, 117485, Russia

Location status: Recruiting

Location contact

Ekaterina S Ikonnikova

SUB_INVESTIGATOR

Olesya Al Mokienko, PhD

CONTACT

[email protected]

+74953747776

Olesya Al Mokienko, PhD

SUB_INVESTIGATOR

Roman Kh Lyukmanov, PhD

CONTACT

[email protected]

4953747776

Roman Kh Lyukmanov, PhD

PRINCIPAL_INVESTIGATOR

About this study

INTERVENTION NIRS-BCI-Korvit System Components: NIRScout hardware-software complex (16 light sources, 8 detectors); Software for brain activity classification; Korvit pneumoorthesis 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/ ASSESSMENT

Motor Function:

  • Fugl-Meyer Scale for Lower Extremity (maximum 34 points, clinically significant improvement ≥6 points);
  • 10-meter Walk Test (clinically significant improvement ≥0.16 m/s);
  • Timed Up and Go Test (clinically significant improvement ≥3 seconds).

Cognitive Functions and Emotional State:

  • Addenbrooke's Cognitive Examination III (ACE III);
  • Hospital Anxiety and Depression Scale (HADS). EXPECTED OUTCOMES.

The study aims to confirm the effectiveness of NIRS-BCI combined with plantar support load simulator for:

  • Gait restoration;
  • Cognitive function improvement;
  • Emotional state normalization in post-stroke patients SAFETY The procedure is safe and poses no health risks. Possible minor fatigue after sessions. The study can be discontinued at any stage upon patient request or if adverse effects occur.

INNOVATION This research represents a novel approach combining non-invasive brain-computer interface technology with proprioceptive feedback systems for comprehensive post-stroke rehabilitation, addressing both motor and cognitive recovery simultaneously

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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

Other names: neurobiofeedback

Primary outcomes

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

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

    Before and after treatment course

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

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

    Before and after treatment course

Secondary outcomes

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

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

    Before and after treatment course

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

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

    Before and after treatment course

Other outcomes

  1. Emotional improvement as assessed by the Hospital Anxiety and Depression Scale

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

    Before and after treatment course

Study contacts

Contact information is provided by the study sponsor or research team.

Olesya Al Mokienko, PhD

CONTACT

[email protected]

+74953747776

Roman Kh Lyukmanov, PhD

CONTACT

[email protected]

+74953747776

Sponsors and collaborators

Lead sponsor

Research Center of Neurology, Russia

Other Gov

Collaborators

  • Institute of Higher Nervous Activity and Neurophysiology of RAS
  • Pirogov Russian National Research Medical University

Registry information

Official study title

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

Acronym: BRAIN-WALK

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2025
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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