Last updated: May 15, 2022
Sponsor: Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine
Overall Status: Active - Recruiting
Phase
N/A
Condition
Stroke
Cerebral Ischemia
Treatment
N/AClinical Study ID
NCT05214521
9 12112020
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Men or women aged 18 to 70 years after a first-onset IS, early (1-6 months), laterecovery (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 MedicalResearch 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 thisprotocol.
Exclusion
Exclusion Criteria:
- Concomitant neurological diseases causing decreased muscle strength or increasedmuscle tone in the UL (e.g., cerebral palsy, brain injury).
- Clinically significant limitation of the passive movement amplitude in the joints ofthe investigated hand, pronounced contracture and deformities of the upper extremity.
- Use of other DIT, BFB techniques to restore impaired UL function within 30 days priorto the patient Inclusion Visit.
- Severe visual impairment, decreased visual acuity of less than 0.2 in the worst eyeaccording to the Golovin-Sivtsev Table24.
- Sensory aphasia, gross motor aphasia.
- Recurrent stroke.
- Unstable angina and/or heart attack in previous month.
- Uncontrolled arterial hypertension.
- Somatic diseases in decompensation stage.
- Alcohol abuse, medical marijuana use or soft drug abuse within the 12 months prior tothe Inclusion Visit.
- Any medical condition, including mental disease or epilepsy that could affect theinterpretation of study results, the study procedures or patient safety.
- Pregnancy.
- Lactation.
Study Design
Total Participants: 30
Study Start date:
January 11, 2021
Estimated Completion Date:
December 30, 2023
Study Description
Connect with a study center
Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine, branch 7
Moscow, 105120
Russian FederationActive - Recruiting
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