Substantiation and Standardization of the Multimodal Cognitive-motor Rehabilitation System for Afterstroke Patients

Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine

Status

Enrolling

Conditions

Stroke Rehabilitation

Treatments

Procedure: Conventional rehabilitation

Procedure: Multimodal technology (MT)

Study type

Interventional

Funder types

Other

Identifiers

NCT05944666

3/15.05.2023

Details and patient eligibility

About

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

Full 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.

Enrollment

405 estimated patients

Sex

All

Ages

45 to 75 years old

Volunteers

No Healthy Volunteers

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

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

405 participants in 5 patient groups

Medical rehabilitation (MR) in acute period of IS-inpatient stage

Experimental group

Description:

Devices Patients in acute period of IS receive a course of standart MR-program and in main group - rehabilitation with multimodal correction using and BFB-stabilometric training, cognitive-motor training in a virtual environment (VR), functional individually programmed stimulation of antagonist muscles of the lower limb (FES), subject-manipulative activity training to restore fine movements of the hand on a glove simulator, if moderate paresis of the upper limb - the neurointerface "Exokist-2" with EEG registration.

Treatment:

Procedure: Multimodal technology (MT)

Procedure: Conventional rehabilitation

MR in early recovery period of IS- inpatient stage

Experimental group

Description:

Devices Patients in the early recovery period of IS receive a course of standart MR-program and in main group - rehabilitation with multimodal correction using and BFB-stabilometric training, cognitive-motor training in a virtual environment (VR), functional individually programmed stimulation of antagonist muscles of the lower limb (FES), subject-manipulative activity training to restore fine movements of the hand on a glove simulator, if moderate paresis of the upper limb - the neurointerface "Exokist-2" with EEG registration.

Treatment:

Procedure: Multimodal technology (MT)

Procedure: Conventional rehabilitation

MR in late recovery period of IS-inpatient stage

Experimental group

Description:

Devices Patients in the late recovery period of IS receive a course of standart MR-program and in main group - rehabilitation with multimodal correction using and BFB-stabilometric training, cognitive-motor training in a virtual environment (VR), functional individually programmed stimulation of antagonist muscles of the lower limb (FES), subject-manipulative activity training to restore fine movements of the hand on a glove simulator, if moderate paresis of the upper limb - the neurointerface "Exokist-2" with EEG registration.

Treatment:

Procedure: Multimodal technology (MT)

Procedure: Conventional rehabilitation

MR in early recovery period of IS - outpatient stage

Experimental group

Description:

Treatment:

Procedure: Multimodal technology (MT)

Procedure: Conventional rehabilitation

MR in late recovery period of IS - outpatient stage

Experimental group

Description: