NCT05391919

Multimodal Correction of Post-stroke Motor and Cognitive Impairments

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine · Academic / Other
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke Rehabilitation

Interventions

Type	Name	Description
OTHER	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.
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.

Timeline

• Start date: 2022-03-17
• Primary completion: 2023-05-31
• Completion: 2023-05-31
• First posted: 2022-05-26
• Last updated: 2023-09-14

Locations

1 site across 1 country: Russia