A Study of Neurorehabilitation Based on Robotics, Brain-Computer Interface (BCI) and Virtual Reality (VR) in Patients with Upper Limb Paresis Due to Stroke in the Early Rehabilitation Period

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Russian Federation
Samara Regional Clinical Hospital named after V.D. Seredavin
RECRUITING
Samara
Contact Information
Primary
Vladimir Bulanov
vb@ntech.team
+79272081176
Backup
Alexander Zakharov, Ph.D.
+79171620301
Time Frame
Start Date: 2024-08-27
Estimated Completion Date: 2025-07
Participants
Target number of participants: 44
Treatments
Active_comparator: Control
The Control group receives a standard course of intervention (14-21 days) as prescribed by the attending physician, in accordance with the standards of the Ministry of Health of the Russian Federation for the provision of medical care to people who have suffered a stroke.
Experimental: MI+VR
In addition to the standard course of intervention, the MI+VR group undergoes 10-12 sessions using a novel simulator involving the paretic arm with immersion in virtual reality.
Experimental: MI2+VR
In addition to the standard course of intervention, the MI2+VR group undergoes 10-12 sessions using a novel simulator involving both arms (healthy and paretic) with immersion in virtual reality.
Experimental: MI2
In addition to the standard course of intervention, the group MI2 undergoes 10-12 sessions using a novel simulator involving both arms (healthy and paretic) without immersion in virtual reality, using a computer display instead.
Related Therapeutic Areas
Sponsors
Collaborators: Samara State Medical University, Samara Regional Clinical Hospital V.D. Seredavin
Leads: Neurotechnika

This content was sourced from clinicaltrials.gov