Brain-controlled foot-pressure system to help walking after stroke
Clinical Evaluation of a Brain-computer Interface Integrated With Plantar Pneumoorthoses for Motor and Cognitive Rehabilitation in Stroke Survivors
NA · Research Center of Neurology, Russia · NCT07081308
This trial tries a brain-controlled foot-pressure device to help adults recovering from stroke regain walking ability and improve thinking and mood.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Research Center of Neurology, Russia (other gov) |
| Locations | 1 site (Moscow) |
| Trial ID | NCT07081308 on ClinicalTrials.gov |
What this trial studies
Researchers compare a new rehabilitation system that links near-infrared spectroscopy (NIRS) brain signals to a plantar pneumoorthosis against standard rehabilitation. Participants sit with their legs in pneumatic orthoses and perform kinesthetic imagery of walking while the NIRScout records brain activity and provides visual and tactile feedback across 10 short sessions. Motor outcomes (Fugl-Meyer lower extremity, 10‑meter walk, Timed Up and Go), cognitive testing (ACE‑III), and mood (HADS) are measured before and after the training. The procedure is noninvasive, expected to be safe, and sessions may cause only minor fatigue.
Who should consider this trial
Good fit: Ideal candidates are adults 18–80 with a supratentorial ischemic stroke 7 days to 24 months earlier, who have mild-to-moderate lower-limb impairment, clinical stability, and can sit and follow instructions.
Not a fit: Patients with severe cognitive impairment, severe aphasia, major visual problems, lower-limb contractures, or inability to maintain sitting are unlikely to benefit.
Why it matters
Potential benefit: If successful, the system could help restore gait, improve cognitive function, and normalize mood after stroke.
How similar studies have performed: Some BCI-based motor-rehabilitation studies have shown promising results, but combining NIRS-based BCI with plantar pneumatic feedback is a novel approach with limited prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Moscow
- Russian center of Neurology and Neurosciences — Moscow, Russia (RECRUITING)
Study contacts
- Study coordinator: Roman Kh Lyukmanov, PhD
- Email: xarisovich@gmail.com
- Phone: +74953747776
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stroke, Brain-computer interface, Near infrared spectroscopy, gait recovery, stroke rehabilitation, Neurobiofeedback