Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06753006

Research on the Effectiveness of Neurorehabilitation After Stroke

Led by Neurotechnika · Updated on 2025-01-01

44

Participants Needed

1

Research Sites

44 weeks

Total Duration

On this page

Sponsors

N

Neurotechnika

Lead Sponsor

S

Samara State Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

This clinical trial aims to investigate the effectiveness of a novel neurorehabilitation technology for treating stroke in adults. The study will evaluate a simulator that combines robotic orthosis, a non-invasive brain-computer interface (BCI), and a virtual reality (VR) display. The goal of this trial is to advance stroke rehabilitation by exploring the potential benefits of these cutting-edge technologies. Key Research Questions: Efficacy: Does the new simulator significantly improve arm function compared to standard rehabilitation techniques? BCI Technology: Which approach - motor imagery of only the paretic arm or both the paretic and healthy arm - yields greater functional improvements? VR Contribution: How does the integration of VR enhance rehabilitation outcomes? Safety and Tolerability: What potential side effects or adverse events may arise from using the new simulator? Participants who have suffered a stroke will undergo a standard rehabilitation course, during which 10-12 sessions will take place using the innovative simulator: a robotic device moves a patient's paralyzed arm at the command of a non-invasive brain-computer interface to perform a game task resembling real-life activities, augmented by a virtual reality display. Researchers will assess the impact of the new technology on arm function to determine its efficacy in promoting recovery.

CONDITIONS

Official Title

Research on the Effectiveness of Neurorehabilitation After Stroke

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 weakness with severity between 0 and 3 on the 6-point Medical Research Council muscle strength scale
  • Ability and willingness to comply with the study protocol
  • Demonstrated motivation for rehabilitation
Not Eligible

You will not qualify if you...

  • Montreal Cognitive Assessment score less than 10 points
  • Hamilton Depression Rating Scale score greater than 18 points
  • Modified Rankin Scale score greater than 4 points
  • Pre-existing conditions causing decreased muscle strength or increased muscle tone in the upper limbs, or rigidity
  • Advanced arthritis or significant limitation of upper limb range of motion
  • Absence of part of the upper limb due to amputation
  • Any medical condition affecting study conduct or patient safety
  • Alcohol abuse or recreational drug use within 12 months prior to study
  • Use of experimental medications or medical devices within 30 days prior to study
  • Inability to comply with research procedures
  • Neurological or physical status preventing full rehabilitation
  • Visual acuity less than 0.2 in the weakest eye
  • Unstable angina or heart attack within 30 days prior to study
  • Recurrent stroke
  • Uncontrolled arterial hypertension
  • Ataxia
  • Presence of pacemaker or other implanted electronic devices
  • Use of muscle relaxants
  • Peripheral neuropathy
  • Coexisting diseases in exacerbation or decompensated stage requiring active treatment
  • Allergic reactions or skin lesions at EEG electrode sites
  • Acute urinary tract infections
  • Acute thrombophlebitis
  • Any form of epilepsy
  • Benign or malignant tumors

AI-Screening

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Trial Site Locations

Total: 1 location

1

Samara Regional Clinical Hospital named after V.D. Seredavin

Samara, Samara Oblast, Russia, 443095

Actively Recruiting

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Research Team

V

Vladimir Bulanov

CONTACT

A

Alexander Zakharov, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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