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
1 other identifier
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Aug 2024
Shorter than P25 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 27, 2024
CompletedFirst Submitted
Initial submission to the registry
December 21, 2024
CompletedFirst Posted
Study publicly available on registry
December 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2025
CompletedJanuary 1, 2025
December 1, 2024
10 months
December 21, 2024
December 31, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (5)
NIHSS
From enrollment to the end of treatment at 2-3 weeks
Ashworth
From enrollment to the end of treatment at 2-3 weeks
RMI
From enrollment to the end of treatment at 2-3 weeks
MRS
From enrollment to the end of treatment at 2-3 weeks
SF-36
From enrollment to the end of treatment at 2-3 weeks
Other Outcomes (1)
ICF
From enrollment to the end of treatment at 2-3 weeks
Study Arms (4)
Control
ACTIVE COMPARATORThe 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.
MI+VR
EXPERIMENTALIn 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.
MI2+VR
EXPERIMENTALIn 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.
MI2
EXPERIMENTALIn 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Neurotechnikalead
- Samara State Medical Universitycollaborator
- Samara Regional Clinical Hospital V.D. Seredavincollaborator
Study Sites (1)
Samara Regional Clinical Hospital named after V.D. Seredavin
Samara, Samara Oblast, 443095, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexander Zakharov, Ph.D.
Samara State Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Participants will be evaluated by blinded assessors before being assigned to one of the study arms, and their rehabilitation outcomes will also be assessed by blinded assessors.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2024
First Posted
December 31, 2024
Study Start
August 27, 2024
Primary Completion
July 1, 2025
Study Completion
July 1, 2025
Last Updated
January 1, 2025
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share
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.