Tests a robotic brain-controlled arm device for stroke arm weakness
Tests a robotic, brain-controlled and virtual reality device for arm weakness after stroke.
Plain-language title generated from the registry record
Registry title: Research on the Effectiveness of Neurorehabilitation After Stroke
Key facts
- Where
- Samara, RussiaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06753006, who can take part
Where in Russia
- Samara Regional Clinical Hospital named after V.D. SeredavinSamara, RussiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Neurotechnika
- Trial code
- NCT06753006
- Record updated
- 1 January 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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; 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); Any medical condition that may affect the conduct of the study or patient safety (e.g., mental illness); The severity of the patient's condition, based on neurological or physical status, does not permit full rehabilitation; Unstable angina and/or heart attack within the 30 days preceding the study; Recurrent stroke; Uncontrolled arterial hypertension; 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; Any form of epilepsy; Benign and malignant neoplasms; 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; Advanced arthritis or significant limitation of upper limb range of motion; Absence of part of the upper limb due to amputation for any reason; Inability to comply with research procedures, as determined by the researcher; Visual acuity less than 0.2 in the weakest eye according to the Sivtsev visual acuity chart; Ataxia; Presence of a pacemaker and/or other implanted electronic devices; Use of muscle relaxants; Peripheral neuropathy; Acute thrombophlebitis.