Effectiveness of a new neurorehabilitation technology for stroke recovery

Is this trial a fit for you?

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

What this trial studies

This clinical trial investigates a novel neurorehabilitation simulator designed to enhance recovery in stroke patients. The simulator integrates robotic orthosis, a non-invasive brain-computer interface (BCI), and virtual reality (VR) to improve arm function. Participants will receive standard rehabilitation alongside this innovative technology, with the study evaluating its efficacy compared to traditional methods. Key research questions include the effectiveness of different BCI approaches and the contribution of VR to rehabilitation outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Signed written informed consent.
* Age 18 to 80 years at the time of stroke onset.
* Early rehabilitation period (up to 6 months post-stroke).
* Diagnosis of acute cerebrovascular accident confirmed by MRI or CT.
* Upper limb paresis severity between 0 and 3 on the 6-point Medical Research Council (MRC) muscle strength scale.
* Ability and willingness to comply with the study protocol.
* Demonstrated motivation for rehabilitation.

Exclusion Criteria:

* Montreal Cognitive Assessment scale (MoCA) score less than 10 points.
* Hamilton Depression Rating Scale (Ham-D) score greater than 18 points.
* Modified Rankin Scale (mRS) score greater than 4 points.
* Pre-existing conditions that cause decreased muscle strength or increased muscle tone in the upper limbs (e.g., cerebral palsy, traumatic brain injury) or rigidity (e.g., Parkinson's disease, contractures).
* Advanced arthritis or significant limitation of upper limb range of motion.
* Absence of part of the upper limb due to amputation for any reason.
* Any medical condition that may affect the conduct of the study or patient safety (e.g., mental illness).
* Alcohol abuse or recreational drug use within the 12 months preceding the study.
* Use of experimental medications or medical devices within the 30 days preceding the study.
* Inability to comply with research procedures, as determined by the researcher.
* The severity of the patient's condition, based on neurological or physical status, does not permit full rehabilitation.
* Visual acuity less than 0.2 in the weakest eye according to the Sivtsev visual acuity chart.
* Unstable angina and/or heart attack within the 30 days preceding the study.
* Recurrent stroke.
* Uncontrolled arterial hypertension.
* Ataxia.
* Presence of a pacemaker and/or other implanted electronic devices.
* Use of muscle relaxants.
* Peripheral neuropathy.
* Coexisting diseases in an exacerbation or decompensated stage requiring active treatment.
* Allergic reactions or other skin lesions at the EEG electrode application sites at the time of the study.
* Acute urinary tract infections.
* Acute thrombophlebitis.
* Any form of epilepsy.
* Benign and malignant neoplasms.

Where it's running

• Samara Regional Clinical Hospital named after V.D. Seredavin
  Samara, Samara Oblast, Russia Recruiting

Study contacts

• Principal investigator: Alexander Zakharov, Ph.D. — Samara State Medical University
• Study coordinator: Vladimir Bulanov
• Email: vb@ntech.team
• Phone: +79272081176

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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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.