Clinical trial NCT05944666: Substantiation and Standardization of the Multimodal Cognitive-motor Rehabilitation System for Afterstroke Patients
Official title: Standardization of the System of Multimodal Cognitive-motor Poststroke Rehabilitation, in Accordance With the Verification of Rehabilitation Potential, Rehabilitation Diagnosis and Patient Model, at the Stages of Medical Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
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
lower limb medical rehabilitation
digital interactive technology
standartized rehabilitation technologies
verification of the rehabilitation potential
Lead sponsor: Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 405
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: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: The aim of the study is to develop and scientifically substantiate a standardized system of multimodal cognitive-motor rehabilitation and its differentiated application in patients with cerebral stroke, according to verified rehabilitation potential based on the patient's rehabilitation model for the stages of medical rehabilitation, including inpatient-replacement technologies

Detailed description: The object of the study The study will include 405 patients (men and women) with the diagnosis of ischemic stroke (IS) in the acute (0-21 day), 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), lower limb (LL), mild or moderate cognitive impairment.

Patients will be randomly assigned to one of 6 experimental groups - 3 main groups of 70 patients each in the acute, early and late recovery period of IS and 3 comparison groups (each of 65 patients) in the acute, early and late recovery periods of IS. The patients in the main and comparison groups will be comparable in age, gender and symptoms.

Each participant of the study will be assigned an ordinal number. Patients of the main groups are planned to undergo a rehabilitation course with standardized 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-2" with EEG registration will be used.

The patients of comparison groups are planned to undergo a rehabilitation course with standart rehabilitation programms depending on the severity of functional and neuropsychological disturbances: kinesiotherapy, physical therapy, occupational therapy, massage.

The study is carried out at the inpatient stage, then patients are transferred to the outpatient stage of rehabilitation or controlled home self-rehabilitation using telemedicine technologies.

The mode of application of multimodal correction technology:

inpatient stage: 10 procedures every day (5 working days, 2 days the rest);the total duration of one procedure is 2-3 hours a day.

outpatient stage: 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:

* Men or women aged 45 to 70 years after a first-onset IS, acute (1-21 days), early (22 days- 6 months), late recovery (6-12 months) periods.
* Supratentorial IS according to MRI of the brain.
* The severity of UL and LL paresis ranged from a score of 4 to 2 according to the Medical Research Council Scale (MRCS)
* Spasticity of 3 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 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.

Primary outcomes:
measure: ICF motor and sensitive domains dynamic
timeFrame: Baseline, visit day 10 of inpatient rehabilitation, visit days 1, 7, 15 of MR in outpatient stage
Secondary outcomes:
measure: ICF cognitive and emotional domains dynamic
timeFrame: Baseline, visit day 10 of inpatient rehabilitation, visit days 1, 7, 15 of MR in outpatient stage
measure: Changes in level of impairment or dependence in daily life
timeFrame: Baseline, visit day 10 of inpatient rehabilitation, visit days 1, 7, 15 of MR in outpatient stage
measure: Changes in Rankin scale
timeFrame: Baseline, visit day 10 of inpatient rehabilitation, visit days 1, 7, 15 of MR in outpatient stage
measure: Canges in Rehabilitation routing scale (RRS)
timeFrame: Baseline, visit day 10 of inpatient rehabilitation, visit days 1, 7, 15 of MR in outpatient stage
measure: Changes of Life quality assessment
timeFrame: Baseline, visit day 10 of inpatient rehabilitation, visit days 1, 7, 15 of MR in outpatient stage
measure: Changes of SF-36 questionnaire
timeFrame: Baseline, visit day 10 of inpatient rehabilitation, visit days 1, 7, 15 of MR in outpatient stage
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine, branch 3 and branch7
Study officials:
References: