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NCT Number: NCT06753006

Research on the Effectiveness of Neurorehabilitation After Stroke

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samara Regional Clinical Hospital named after V.D. Seredavin

Samara, Samara Oblast, 443095, Russia

Location status: Recruiting

Location contact

Alexander Zakharov, Ph.D.

CONTACT

[email protected]

+79171620301

Alexander Zakharov, Ph.D.

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neurorehabilitation simulator

Device

The participant must complete a mental task - imagine the movement of his arm. If successful, the robotic simulator moves the paralyzed limb.

Standard course

Procedure

The participant receives a standard course of intervention as prescribed by the attending physician in accordance

Primary outcomes

  1. FMA-UE A-D

    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.

  2. ARAT

    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.

Secondary outcomes

  1. NIHSS

    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.

  2. Ashworth

    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.

  3. RMI

    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.

  4. MRS

    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.

  5. SF-36

    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.

Other outcomes

  1. ICF

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander Zakharov, Ph.D.

CONTACT

+79171620301

Vladimir Bulanov

CONTACT

[email protected]

+79272081176

Sponsors and collaborators

Lead sponsor

Neurotechnika

Industry

Collaborators

  • Samara Regional Clinical Hospital V.D. Seredavin
  • Samara State Medical University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 31, 2024
Registry last updated
Jan 1, 2025

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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