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

NCT05944666 | Unknown

• 1 other identifier: 3/15.05.2023
• Study Type: interventional
• Target: 405
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• ICF motor and sensitive domains dynamic

  Changes in the severity of dysfunctions by at least 1 determinant point of at least 1 of the selected ICF domains characterizing motor stereotype, balance at rest and when walking, fine motor skills of the upper limb, sensory disorders, pain syndrome

  Baseline, visit day 10 of inpatient rehabilitation, visit days 1, 7, 15 of MR in outpatient stage

Secondary Outcomes (6)

• ICF cognitive and emotional domains dynamic

  Baseline, visit day 10 of inpatient rehabilitation, visit days 1, 7, 15 of MR in outpatient stage

• Changes in level of impairment or dependence in daily life

  Baseline, visit day 10 of inpatient rehabilitation, visit days 1, 7, 15 of MR in outpatient stage

• Changes in Rankin scale

  Baseline, visit day 10 of inpatient rehabilitation, visit days 1, 7, 15 of MR in outpatient stage

• Canges in Rehabilitation routing scale (RRS)

  Baseline, visit day 10 of inpatient rehabilitation, visit days 1, 7, 15 of MR in outpatient stage

• Changes of Life quality assessment

  Baseline, visit day 10 of inpatient rehabilitation, visit days 1, 7, 15 of MR in outpatient stage

Study Arms (5)

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

EXPERIMENTAL

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.

Procedure: Multimodal technology (MT); Procedure: Conventional rehabilitation

MR in early recovery period of IS- inpatient stage

EXPERIMENTAL

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.

Procedure: Multimodal technology (MT); Procedure: Conventional rehabilitation

MR in late recovery period of IS-inpatient stage

EXPERIMENTAL

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.

Procedure: Multimodal technology (MT); Procedure: Conventional rehabilitation

MR in early recovery period of IS - outpatient stage

EXPERIMENTAL

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.

Procedure: Multimodal technology (MT); Procedure: Conventional rehabilitation

MR in late recovery period of IS - outpatient stage

EXPERIMENTAL

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.

Procedure: Multimodal technology (MT); Procedure: Conventional rehabilitation

Interventions

Multimodal technology (MT) PROCEDURE

Only fo the patients of the Main group. It will be different programms depending on severety of UL or LL paresis. Patients will receive a course of rehabilitation with multimodal correction using BFB-stabilometric training, cognitive-motor training with double and triple tasks once a day for the affected hand, virtual reality, 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, in moderate paresis of the upper limb, the neurointerface "Exokist-2" with EEG registration will be used. The program for IS patients includes 10 sessions in inpatient stage every day 15-30 min for the method, 15 sessions with the MT in outpatient stage: 15-30 minutes every method 2-3 times a week, 5-8 weeks.The total duration of one procedure is 2-3 hours.

MR in early recovery period of IS - outpatient stage; MR in early recovery period of IS- inpatient stage; MR in late recovery period of IS - outpatient stage; MR in late recovery period of IS-inpatient stage; Medical rehabilitation (MR) in acute period of IS-inpatient stage

Conventional rehabilitation PROCEDURE

It will be different programms depending on severety of UL or LL paresis. Conventional rehabilitation (CR) includes physiotherapy, kinesiotherapy, occupational therapy. The program for IS patients consists of 10 sessions of every day trainings for inpatients stage, 15 sessions with the CR for outpatient stage: 15-30 minutes every method 2-3 times a week, 5-8 weeks.The total duration of one procedure is 2-3 hours.

MR in early recovery period of IS - outpatient stage; MR in early recovery period of IS- inpatient stage; MR in late recovery period of IS - outpatient stage; MR in late recovery period of IS-inpatient stage; Medical rehabilitation (MR) in acute period of IS-inpatient stage

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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
• Any medical condition, including mental disease or epilepsy that could affect the interpretation of study results, the study procedures or patient safety.
• Pregnancy. 16. Lactation.

Sponsors & Collaborators

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

Study Sites (1)

Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine, branch 3 and branch7

Moscow, 105120, Russia

RECRUITING

Central Study Contacts

Elena V Kostenko, MD

CONTACT

+79057685856; ekostenko58@mail.ru

Liudmila V Petrova, Ph.D

CONTACT

+79163940742; ludmila.v.petrova@yandex.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: July 13, 2023
• Study Start: May 15, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: July 13, 2023

Record last verified: 2023-07

Locations

RU (1)