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Tests treatment safety and results for Stroke
Official title Research on the Effectiveness of Neurorehabilitation After Stroke
ClinicalTrials.gov ID: NCT06753006
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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.
You likely can't join 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...
- Advanced arthritis or significant limitation of upper limb range of motion.
- Absence of part of the upper limb due to amputation for any reason.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Samara, Samara Oblast, Russia
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Samara, Samara Oblast, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.