Research on the Effectiveness of Neurorehabilitation After Stroke

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Stroke, Ischemic; Stroke, Acute; Stroke Acute; Stroke, Acute, Ischemic; Stroke with Hemiparesis
• Intervention / Treatment: Procedure: Standard course; Device: Neurorehabilitation simulator

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vladimir Bulanov; Phone Number: +79272081176; Email: vb@ntech.team
• Study Contact Backup: Name: Alexander Zakharov, Ph.D.; Phone Number: +79171620301

Study Locations

• Russian Federation
  • Samara Region
    • Samara, Samara Region, Russian Federation, 443095
      • Recruiting
      • Samara Regional Clinical Hospital named after V.D. Seredavin
      • Contact: Alexander Zakharov, Ph.D.; Phone Number: +79171620301; Email: a.v.zaharov@samsmu.ru
      • Contact: Alexander Zakharov, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: Standard course; The participant receives a standard course of intervention as prescribed by the attending physician in accordance
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.	Procedure: Standard course; The participant receives a standard course of intervention as prescribed by the attending physician in accordance; Device: Neurorehabilitation simulator; The participant must complete a mental task - imagine the movement of his arm. If successful, the robotic simulator moves the paralyzed limb.
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.	Procedure: Standard course; The participant receives a standard course of intervention as prescribed by the attending physician in accordance; Device: Neurorehabilitation simulator; The participant must complete a mental task - imagine the movement of his arm. If successful, the robotic simulator moves the paralyzed limb.
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.	Procedure: Standard course; The participant receives a standard course of intervention as prescribed by the attending physician in accordance; Device: Neurorehabilitation simulator; The participant must complete a mental task - imagine the movement of his arm. If successful, the robotic simulator moves the paralyzed limb.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FMA-UE A-D	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.	From enrollment to the end of treatment at 2-3 weeks
ARAT	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.	From enrollment to the end of treatment at 2-3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NIHSS	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.	From enrollment to the end of treatment at 2-3 weeks
Ashworth	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.	From enrollment to the end of treatment at 2-3 weeks
RMI	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.	From enrollment to the end of treatment at 2-3 weeks
MRS	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.	From enrollment to the end of treatment at 2-3 weeks
SF-36	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.	From enrollment to the end of treatment at 2-3 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICF	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	From enrollment to the end of treatment at 2-3 weeks

Collaborators and Investigators

• Sponsor: Neurotechnika
• Collaborators: Samara State Medical University; Samara Regional Clinical Hospital V.D. Seredavin
• Investigators: Principal Investigator: Alexander Zakharov, Ph.D., Samara State Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: December 21, 2024
• First Submitted That Met QC Criteria: December 21, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 31, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Rehabilitation; Brain-Computer Interface; Stroke; Robotics; Virtual Reality; Neurofeedback; Motor Imagery
• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Ischemic Stroke; Stroke; Ischemia; Paresis
• Other Study ID Numbers: NT-STROKE-2024-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only authorized members of the research team will have access to individual participant data (IPD). The research team will not share any IPD with third parties. However, de-identified demographic and clinical data-such as treatment details, baseline characteristics, and outcome measures-will be made publicly available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No