Multimodal Correction of Post-stroke Motor and Cognitive Impairments

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-17

Study Completion Date

2023-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT05944666

Stroke Rehabilitation

RECRUITING NA

Oculomotor and Cognitive Rehabilitation Using Visual Feedback in Stroke Patients

NCT05309148

Stroke Oculomotor; Disorder Attention Disturbances

UNKNOWN NA

Multi-domain Improvements in High-TEchnology Rehabilitation Programs for Post-stroke Patients

NCT06489145

Stroke

RECRUITING NA

Innovative Technologies in Restoring Gait and Balance Funtions in Ischemic Stroke Patients at the Inpatient Stage

NCT05423626

Ischemic Stroke, Acute

UNKNOWN NA

Recovery of Motor Skills With the Use of Artificial Intelligence and Computer Vision

NCT06183970

Stroke Hemiparesis Spasticity as Sequela of Stroke +1 more

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke Rehabilitation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Open lable randomized clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MT in early recovery period of IS

Patients in early recovery period of IS receive a course of rehabilitation with multimodal correction using 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 "SensoRehab", if moderate paresis of the upper limb - the neurointerface "Exokist-3" with EEG registration.

Group Type EXPERIMENTAL

Multimodal technology (MT)

Intervention Type OTHER

Patients will receive a course of rehabilitation with multimodal correction using BOS-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 "SensoRehab", in moderate paresis of the upper limb, the neurointerface "Exokist-3" with EEG registration will be used. The program for IS patients includes 15 sessions with the MT: 15-30 minutes every method 2-3 times a week, 5-8 weeks.The total duration of one procedure is 2-3 hours.

MT in late recovery period of IS

Patients in late recovery period of IS receive a course of rehabilitation with multimodal correction using 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 "SensoRehab", if moderate paresis of the upper limb - the neurointerface "Exokist-3" with EEG registration.

Group Type EXPERIMENTAL

Multimodal technology (MT)

Intervention Type OTHER

Patients will receive a course of rehabilitation with multimodal correction using BOS-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 "SensoRehab", in moderate paresis of the upper limb, the neurointerface "Exokist-3" with EEG registration will be used. The program for IS patients includes 15 sessions with the MT: 15-30 minutes every method 2-3 times a week, 5-8 weeks.The total duration of one procedure is 2-3 hours.

No MT Intervention: Conventional IS rehabilitation

Patients in early and late recovery period of IS recieve conventional complex rehabilitation: kinesiotherapy, physiotherapy, occupational therapy.

Group Type ACTIVE_COMPARATOR

Conventional rehabilitation (CR)

Intervention Type OTHER

The patients will recieve Conventional rehabilitation technology (physiotherapy, kinesiotherapy, occupational therapy. The program for IS patients includes 15 sessions with the CR: 15-30 minutes every method 2-3 times a week, 5-8 weeks.The total duration of one procedure is 2-3 hours.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Multimodal technology (MT)

Patients will receive a course of rehabilitation with multimodal correction using BOS-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 "SensoRehab", in moderate paresis of the upper limb, the neurointerface "Exokist-3" with EEG registration will be used. The program for IS patients includes 15 sessions with the MT: 15-30 minutes every method 2-3 times a week, 5-8 weeks.The total duration of one procedure is 2-3 hours.

Intervention Type OTHER

Conventional rehabilitation (CR)

The patients will recieve Conventional rehabilitation technology (physiotherapy, kinesiotherapy, occupational therapy. The program for IS patients includes 15 sessions with the CR: 15-30 minutes every method 2-3 times a week, 5-8 weeks.The total duration of one procedure is 2-3 hours.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

\-

Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Elena V Kostenko, PhD, D. Sс (Medicine)

Role: STUDY_DIRECTOR

Moscow scientific and practical center of medical rehabilitation, restorative and sports medicine of the Department of health of the city of Moscow, branch 7;