Research on the Effectiveness of Neurorehabilitation After Stroke

Not Applicable

Recruiting

• Conditions: Stroke; Stroke Acute; Stroke with Hemiparesis; Stroke, Acute; Stroke, Acute, Ischemic; Stroke, Ischemic

• Registration Number: NCT06753006
• Lead Sponsor: Neurotechnika

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-27
• Status Verified: 2024-12
• Study First Submitted: 2024-12-21
• Study First Submitted QC: 2024-12-21
• Study First Posted: 2024-12-31
• Last Update Submitted: 2024-12-31
• Last Update Posted: 2025-01-01
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
FMA-UE A-D	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.
ARAT	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 Outcome Measures

Name	Time	Method
NIHSS	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.
Ashworth	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.
RMI	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.
MRS	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.
SF-36	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.

Trial Locations

Locations (1)

Samara Regional Clinical Hospital named after V.D. Seredavin; 🇷🇺 Samara, Samara Region, Russian Federation