Multimodal Correction of Post-stroke Motor and Cognitive Impairments With the Integrated Use of Innovative Digital Technologies, Biofeedback, Virtual Reality, a Neurointerface With Cardiovascular Risks Monitoring in an Outpatient Clinic
Trial ID: NCT05391919
Status: COMPLETED
Study type: INTERVENTIONAL
Phase: NA
Start date: 2022-03-17
Completion date: 2023-05-31
Sponsor: Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine
Collaborators: Moscow Government
Conditions: Stroke Rehabilitation
Interventions: Multimodal technology (MT); Conventional rehabilitation (CR)
Locations: Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine, branch 7
Countries: Russia
Enrollment: 90
Age range: 45 Years - 75 Years
Sex: ALL

Summary:
The aim of the study is the development and scientific substantiation of the effectiveness and safety of multimodal rehabilitation technology using innovative digital technologies, biofeedback (BFB), virtual reality (VR), neurointerface for the restoration of stato-locomotor disorders, neuromuscular control of upper limb movements and cognitive functions in patients with ischemic stroke (IS) in different recovery periods with rehabilitation risks control in outpatient clinic.

Eligibility criteria:
Inclusion Criteria:

1. Men or women aged 45 to 70 years after a first-onset IS, early (1-6 months), late recovery (6-12 months) periods.
2. Supratentorial IS according to MRI of the brain.
3. The severity of UL paresis ranged from a score of 4 to 3 according to the Medical Research Council Scale (MRCS).20
4. Spasticity of 2 points or less by the Modified Ashworth Scale (MAS)
5. Cognitive function more than 20 points on the Montreal Cognitive Assessment (MoCA)
6. Affective disorders score less than 11 on the Hospital Anxiety and Depression Scale (HADS)
7. The patient's ability and willingness to comply with the requirements of this protocol.

Exclusion Criteria:

1. Concomitant neurological diseases causing decreased muscle strength or increased muscle tone in the UL (e.g., cerebral palsy, brain injury).
2. Clinically significant limitation of the passive movement amplitude in the joints of the investigated hand, pronounced contracture and deformities of the upper extremity.
3. Use of other DIT, BFB techniques to restore impaired UL function within 30 days prior to the patient Inclusion Visit.
4. Severe visual impairment, decreased visual acuity of less than 0.2 in the worst eye according to the Golovin-Sivtsev Table24.
5. Sensory aphasia, gross motor aphasia.
6. Recurrent stroke.
7. Epilepsy
8. Unstable angina and/or heart attack in previous month.
9. Uncontrolled arterial hypertension.
10. Somatic diseases in decompensation stage.
11. Thrombosis of deep and superficial veins of the lower extremities
12. The presence of left-handedness in the patient according to the Edinburgh manual asymmetry questionnaire
13. Alcohol abuse, medical marijuana use or soft drug abuse within the 12 months prior to the Inclusion Visit.
14. Any medical condition, including mental disease or epilepsy that could affect the interpretation of study results, the study procedures or patient safety.

15 Pregnancy. 16. Lactation.

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Outcomes:
Fugl-Meyer Upper Extremity Scale (FMA-UE) dynamic; Action Research Arm Test (ARAT) Scale dynamic; Change from Baseline in 10 Metre Walk Test; Change from Baseline in Tinetti test; Changes in cognitive status; Change from Baseline of Presence and severity of depression and anxiety; Restoration of CNS function