Clinical Evaluation of a Brain-computer Interface Integrated With Plantar Pneumoorthoses for Motor and Cognitive Rehabilitation in Stroke Survivors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Walking speed change as assessed by the 10-Meter Walk Test
Study Overview
Brief 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.
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
BCI
Stroke patients receiving NIRS-BCI-pneumoorthesis training in combination with standard therapy
Intervention: NIRS-BCI-pneumoorthesis (Device)
Control
Stroke patients receiving standard therapy
Outcomes
Primary Outcomes
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
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
- Lower extremity functional improvement as assessed by the Timed Up and GO test(From enrollment to the end of treatment at 2 weeks)
- Cognitive function improvement as assessed by the Addenbrooke's cognitive examination - III("From enrollment to the end of treatment at 2 weeks)
Investigators
Natalia Suponeva
Director of Institute
Research Center of Neurology, Russia