Status:
UNKNOWN
Innovative Technologies in Restoring Gait and Balance Funtions in Ischemic Stroke Patients at the Inpatient Stage
Lead Sponsor:
Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine
Conditions:
Ischemic Stroke, Acute
Eligibility:
All Genders
19-75 years
Phase:
NA
Brief Summary
The scientific hypothesis was based on data on the effectiveness of the usage of robotic mechanotherapy and virtual reality technologies. Purpose of the study is the development and scientific substan...
Detailed Description
The purpose of the study: Development and scientific substantiation of the effectiveness and safety of rehabilitation programs using the technology of robotic mechanotherapy (exoskeleton) with functi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05423626
Start Date
March 18 2022
End Date
December 31 2023
Last Update
June 21 2022
Active Locations (1)
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1
Moscow Centre for Research and Practice in Medical Rehabilitation, Restorative and Sports Medicine of Moscow Healthcare Department, Branch No. 3
Moscow, Russia, 111674