Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2025-12-26 @ 4:03 PM
NCT ID:
NCT06753006
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.
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06753006
Study Brief:
Protocol Section:
NCT06753006