Innovative Technologies in Restoring Gait and Balance Funtions in Ischemic Stroke Patients at the Inpatient Stage
Ischemic Stroke, Acute
About this trial
This is an interventional treatment trial for Ischemic Stroke, Acute focused on measuring Ischemic Stroke, Acute ischemic stroke, Early recovery period, Exoskeleton, Virtual reality, Biofeedback, Robotic mechanotherapy, Lower limb medical rehabilitation
Eligibility Criteria
Inclusion Criteria:
- Availability of signed informed consent
- Patients with ischemic stroke in the acute and early recovery period, from 5 days to 6 months after the stroke.
- Men and women from 19 to 75 years old.
- The ability to be in a standing position without a pronounced decrease in blood pressure (at least 15 minutes).
- For stroke patients, the score on the scale of muscle strength in the lower extremities is 0-4 points.
- Weight not more than 100 kg
- Height from 160 to 190 cm .
- High motivation for recovery
- Preservation of cognitive functions (at least 27 points on MoCA)
- Rating on the Rankin scale 3-4 points-
Exclusion Criteria:
- Refusal of the patient to sign an informed consent to participate in the study and refusal to cooperate;
- Inability to be in a standing position (less than 15 minutes), due to pathological vegetative reactions (orthostatic hypotension, tachycardia, bradycardia, arrhythmia, etc.);
- Pregnant, lactating women and women planning pregnancy
- The severity and instability of the somatic condition that prevents verticalization, the presence of contraindications for physical exertion and walking.
- Acute infectious diseases, febrile syndrome;
- Availability of pacemakers;
- Blood pathologies;
- Active form of rheumatism
- Condition after stitching of muscles, tendons, nerves
- Chronic diseases in the decompensation stage;
- Severe vegetative dysreflexia, uncontrolled arterial hypertension (AD system. more than 180 mm Hg, AD diast. more than 100 mm Hg);
- Attacks of angina pectoris at rest or ECG-signs of myocardial ischemia at rest;
- Myocardial infarction less than 6 months ago;
- Heart defects;
- Paroxysmal and persistent form of atrial fibrillation;
- Sinus bradycardia (less than 50 beats per minute) and tachycardia (more than 90 beats per minute). At rest and more than 130 beats . in min. under load);
- Atrioventricular block of I-III degree;
- Acute venous thrombosis and / or thrombophlebitis of any localization, edema of the lower extremities 2-3 art.
- Circulatory insufficiency above functional class II according to NYHA
- Aneurysm of the aorta and cerebral arteries;
- Hypercoagulation, erythrocytosis.
- Decompensation of diabetes mellitus.
- Trophic disorders - bedsores in the places of attachment of the exoskeleton;
- Epilepsy and other paroxysmal disorders of consciousness;
- Ankylosis, fixed contractures, deforming arthrosis 3-4 ct, arthritis/synovitis, condition after endoprosthetics, arthroplasty of the joints of the lower extremities;
- Ungrown fractures or unstable osteosynthesis of the spine, pelvic bones, lower extremities;
- Instability (subluxations and dislocations) in the joints of the legs
- Pronounced muscle spasticity (more than 3 points) or significant growth after training;
- Osteoporosis
- Systemic connective tissue diseases
- Malignant tumors.
- Motor and sensory aphasia
- Cognitive impairment (less than 26 points on MoCA)
- Increasing/persistent compression of the spinal cord, its roots, ponytail or ves
Sites / Locations
- Moscow Centre for Research and Practice in Medical Rehabilitation, Restorative and Sports Medicine of Moscow Healthcare Department, Branch No. 3Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
No Intervention
technologies of robotic mechanotherapy with FES
biofeedback virtual reality technologies
Complex application of robotic mechanotherapy technologies with FES and VR with biological feedback
Control group
In the course of this study, each patient will be given 10 sessions using the ExoAtlet I robotic simulator. The duration of the procedure, according to the patient's condition, is up to 1 hour (taking into account the time for reconfiguring the exoskeleton and positioning the patient). Measurement of pulse, pressure and saturation in the preparatory, main and final parts. The length of stay in an upright position depends on the patient's condition. In order to study and monitor the state of the cardiovascular system during the procedure, the system of remote monitoring of ECG, breathing and movement "Accordis" will be connected. If necessary, a pause is made to rest in a standing or sitting position. The transition to the formation of subsequent skills is recommended after mastering the skills of the previous procedure.
The group will have 10 classes on a simulator using the technology of virtual reality with biofeedback "ReviVR". The total duration of the procedure is 30 minutes. Before the procedure, blood pressure and heart rate are measured, the size of the pneumatic cuffs on the feet is selected. After instructing the patient and selecting the virtual environment and the optimal speed of movement in VR, VR glasses are installed. Then rehabilitation exercises are carried out for 15 minutes. The patient moves in a virtual environment, receiving visual, auditory and tactile signals that form the correct walking pattern. At the end of the training, the VR glasses are dismantled. Then blood pressure and heart rate are measured and information about the state of health and sensations during the procedure is recorded.
The group plans to carry out comprehensive rehabilitation with the use of robotic mechanotherapy and virtual reality with BOS. In this group, patients will first practice for 30 minutes on a VR simulator with a BFB (the duct is identical to group 2), then after 2 hours on an exoskeleton with a FES (the protocol of the lesson is identical to group 1)
control group with basic course of reabilitation