Clinical trial Recruiting at 1 site Interventional Ages 18 to 80

Brain-controlled foot-pressure system to help walking after stroke

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

Run by Research Center of Neurology, Russia · NCT07081308 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment30 (estimated)
SponsorResearch Center of Neurology, Russia
Government
Locations1 site (Moscow)
StatusRecruiting
StartedOctober 5, 2024
Main results expectedOctober 30, 2026
Study endsDecember 31, 2026
Registry record updatedJuly 28, 2025
Trial IDNCT07081308 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Russian center of Neurology and Neurosciences
    Moscow, Russia
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.