Clinical trial NCT05391919: Multimodal Correction of Post-stroke Motor and Cognitive Impairments
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke Rehabilitation
Keywords: ischemic stroke rehabilitation
post-stroke dysfunction of the hand
cognitive disfunction
artificial intelligence
virtual reality
neurointerface
smart glove
biofeedback
cardiology risk control
upper limb medical rehabilitation
digital interactive technology
Lead sponsor: Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine
Sponsor class: OTHER
Collaborators: name: Moscow Government
First posted: 2022-05-26
Enrollment: 90
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open lable randomized clinical trial
Primary purpose: TREATMENT

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), 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.

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 with stato-locomotor disturbances, dysfunction (violation of neuromuscular movement control) of the upper limb (UL), mild or moderate cognitive impairment.

Patients will be randomly assigned to one of three experimental groups - 2 main groups in the early (30 patients) and in the late recovery period (30 patients) of IS and 1 comparison group (30 patients) in the early and late recovery periods of IS.

Each participant of the study will be assigned an ordinal number. Patients of the 1st and 2nd main groups are planned to undergo a rehabilitation course with multimodal correction, depending on the severity of functional and neuropsychological disturbances with the use of FBF-stabilometric training, cognitive-motor training with double and triple tasks in a virtual environment, functional individually programmed stimulation of antagonist muscles of the lower limb (FES), training of subject-manipulative activity for the restoration of fine hand movements on the glove simulator "SensoRehab"; when severe and moderate paresis of the upper limb, the neurointerface "Exokist-3" with EEG registration will be used.

The mode of application of multimodal correction technology: 15 procedures, 2-3 times a week, the duration of the course is 5-8 weeks. The total duration of one procedure is 2-3 hours a day.

Multimodal correction technology will not be included in the rehabilitation program of patients in the comparison group.

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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Primary outcomes:
measure: Fugl-Meyer Upper Extremity Scale (FMA-UE) dynamic
timeFrame: Baseline, day 7, day 15 of MT and 6 weeks after completing training
measure: Action Research Arm Test (ARAT) Scale dynamic
timeFrame: Baseline, day 7, day 15 of MT and 6 weeks after completing training
measure: Change from Baseline in 10 Metre Walk Test
timeFrame: Baseline, day 7, day 15 of MT and 6 weeks after completing training
measure: Change from Baseline in Tinetti test
timeFrame: Baseline, day 7, day 15 of MT and 6 weeks after completing training
measure: Changes in cognitive status
timeFrame: Baseline, day 7, day 15 of MT and 6 weeks after completing training
measure: Change from Baseline of Presence and severity of depression and anxiety
timeFrame: Baseline, day 7, day 15 of MT and 6 weeks after completing training
measure: Restoration of CNS function
timeFrame: Baseline, day 15 of MT
Secondary outcomes:
measure: Percentage of correctly performed tasks
timeFrame: Baseline, day 7, day 15
measure: change in the paresis degree ин the 6-point Medical Research Council Scale for assessing muscle strength: MRCS
timeFrame: Baseline, day 7, day 15 of MT and 6 weeks after completing training
measure: Changes in spasticity severity
timeFrame: Baseline, day 7, day 15 of MT and 6 weeks after completing training
measure: Changes in level of impairment or dependence in daily life
timeFrame: Baseline, day 7, day 15 of MT and 6 weeks after completing training
measure: Changes of Life quality assessment
timeFrame: Baseline, day 7, day 15 of MT and 6 weeks after completing training
measure: Canges in Rehabilitation routing scale.
timeFrame: Baseline, day 15 of MT and 6 weeks after completing training
measure: Changes by international scale of functioning, disability and health (ISF)
timeFrame: Baseline, day 15 of MT and 6 weeks after completing training
Other outcomes:
measure: Number of participants with abnormal electrocardiogram (ECG) readings
timeFrame: Baseline, day 1-15 of MT
measure: Number of participants with abnormal electroencephalogram (EEG) readings
timeFrame: Baseline, day 15 of MT
Locations:
city: Moscow
country: Russian Federation
facility: Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine, branch 7
Study officials:
affiliation: Moscow scientific and practical center of medical rehabilitation, restorative and sports medicine of the Department of health of the city of Moscow, branch 7;
name: Elena V Kostenko, PhD, D. Sс (Medicine)
role: STUDY_DIRECTOR
References: