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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Neurotechnika
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- FMA-UE A-D
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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.
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
- 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)