Status:
COMPLETED
Multimodal Correction of Post-stroke Motor and Cognitive Impairments
Lead Sponsor:
Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine
Collaborating Sponsors:
Moscow Government
Conditions:
Stroke Rehabilitation
Eligibility:
All Genders
45-75 years
Phase:
NA
Brief 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), ...
Detailed Description
The object of the study The study will include 90 patients (men and women) with the diagnosis of ischemic stroke (IS) in the early recovery (up to 6 months) and late recovery (6-12 months) periods wit...
Eligibility Criteria
Inclusion
- Men or women aged 45 to 70 years after a first-onset IS, early (1-6 months), late recovery (6-12 months) periods.
- Supratentorial IS according to MRI of the brain.
- The severity of UL paresis ranged from a score of 4 to 3 according to the Medical Research Council Scale (MRCS).20
- Spasticity of 2 points or less by the Modified Ashworth Scale (MAS)
- Cognitive function more than 20 points on the Montreal Cognitive Assessment (MoCA)
- Affective disorders score less than 11 on the Hospital Anxiety and Depression Scale (HADS)
- The patient's ability and willingness to comply with the requirements of this protocol.
Exclusion
- Concomitant neurological diseases causing decreased muscle strength or increased muscle tone in the UL (e.g., cerebral palsy, brain injury).
- Clinically significant limitation of the passive movement amplitude in the joints of the investigated hand, pronounced contracture and deformities of the upper extremity.
- Use of other DIT, BFB techniques to restore impaired UL function within 30 days prior to the patient Inclusion Visit.
- Severe visual impairment, decreased visual acuity of less than 0.2 in the worst eye according to the Golovin-Sivtsev Table24.
- Sensory aphasia, gross motor aphasia.
- Recurrent stroke.
- Epilepsy
- Unstable angina and/or heart attack in previous month.
- Uncontrolled arterial hypertension.
- Somatic diseases in decompensation stage.
- Thrombosis of deep and superficial veins of the lower extremities
- The presence of left-handedness in the patient according to the Edinburgh manual asymmetry questionnaire
- Alcohol abuse, medical marijuana use or soft drug abuse within the 12 months prior to the Inclusion Visit.
- 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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Key Trial Info
Start Date :
March 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2023
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05391919
Start Date
March 17 2022
End Date
May 31 2023
Last Update
September 14 2023
Active Locations (1)
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1
Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine, branch 7
Moscow, Russia, 105120