Research on the Effectiveness of Neurorehabilitation After Stroke
Eligible age
18–80 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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.
Sponsor: Neurotechnika
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.
Source: ClinicalTrials.gov · NCT06753006 · last updated 2025-01-01