Samara Regional Clinical Hospital named after V.D. Seredavin
Samara, Samara Oblast, 443095, Russia
Location status: Recruiting
NCT Number: NCT06753006
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Samara, Samara Oblast, 443095, Russia
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The participant must complete a mental task - imagine the movement of his arm. If successful, the robotic simulator moves the paralyzed limb.
The participant receives a standard course of intervention as prescribed by the attending physician in accordance
Time frame: From enrollment to the end of treatment at 2-3 weeks
The Fugl-Meyer Assessment for Upper Extremity, parts A-D (FMA-UE A-D) evaluates a patient's motor function, with scores ranging from 0 (indicating the most severe impairment) to 66 (indicating no impairment). Details available at https://www.gu.se/en/neuroscience-physiology/fugl-meyer-assessment.
Time frame: From enrollment to the end of treatment at 2-3 weeks
The Action Research Arm Test (ARAT) evaluates a patient's ability to handle objects of various sizes, weights, and shapes, making it a specific measure of arm-related activity limitations. Scores range from 0 (indicating the most severe impairment) to 57 (indicating no impairment). Details available at https://strokengine.ca/en/assessments/action-research-arm-test-arat.
Time frame: From enrollment to the end of treatment at 2-3 weeks
Dynamics according to the National Institutes of Health Stroke Scale (NIHSS) that assesses a stroke patient's neurological impairment and degree of recovery for patients with stroke in the range from 0 (no impairment) to 42 (very severe impairment). Details available at https://strokengine.ca/en/assessments/nihss.
Time frame: From enrollment to the end of treatment at 2-3 weeks
Dynamics according to the Ashworth Spasticity Scale that assesses a patient's spasticity in the range from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension). Details available at https://www.sralab.org/rehabilitation-measures/ashworth-scale-modified-ashworth-scale.
Time frame: From enrollment to the end of treatment at 2-3 weeks
Dynamics according to the Rivermead Mobility Index (RMI) that assesses a patient's functional abilities such as gait, balance, and transfers in the range from 0 (worst mobility performance) to 15 (best mobility performance). Details available at https://strokengine.ca/en/assessments/rivermead-mobility-index-rmi.
Time frame: From enrollment to the end of treatment at 2-3 weeks
Dynamics according to the Modified Rankin Scale (MRS) that assesses a patient's level of functional independence in the range from 0 (no symptoms) to 5 (severe disability). Details available at https://strokengine.ca/en/assessments/modified-rankin-scale-mrs.
Time frame: From enrollment to the end of treatment at 2-3 weeks
The SF-36 is a multi-purpose survey designed to capture adult patients' perceptions of their own health and well-being. Scores range from 0 (maximum disability) to 100 (no disability). Details available at https://nexusipe.org/advancing/assessment-evaluation/short-form-sf-36-health-survey.
Time frame: From enrollment to the end of treatment at 2-3 weeks
The International Classification of Functioning, Disability and Health, known more commonly as ICF, is a classification of health and health-related domains. The ICF will be used to assess the impairment of body functions resulting from a stroke. Details available at https://www.who.int/standards/classifications/international-classification-of-functioning-disability-and-health
Contact information is provided by the study sponsor or research team.
Alexander Zakharov, Ph.D.
CONTACT
Vladimir Bulanov
CONTACT
Neurotechnika
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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