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

Summary

The scientific hypothesis was based on data on the effectiveness of the usage of robotic mechanotherapy and virtual reality technologies. Purpose of the study is the development and scientific substantiation of the effectiveness and safety of rehabilitation programs using the technology of robotic mechanotherapy (exoskeleton) with functional electrical stimulation (FES) and virtual reality (VR) technology with biofeedback (BFB) in restoring walking and balance disorders at the stationary stage of medical rehabilitation in patients in acute and early recovery periods of ischemic stroke. The duration of the study is 2 years. The study is planned to include 120 patients. Anamnesis collection, physical and neurological examination will be carried out for all patients upon admission. Diagnostic transcranial magnetic stimulation, electroencephalography and stabilometry will also be performed upon admission and discharge. Adverse events will be assessed. On the last day of the study, the dynamics of the volume and strength of movements, functional independence and spasticity will be assessed according to the scales (MRC, NIHSS, mAS, mRS, Rivermead, Hauser walking index, Tinetti scale, SHRM, ICF, Tampa scale, EQ-5D-5L), as well as the assessment of mental and cognitive status according to HADs and MoCA. Patients will be randomly divided into 4 groups: 3 main and 1 control. All patients will undergo a basic rehabilitation course. In the first group (exoskeleton with FES): 10 procedures, 5 times a week, the duration of the course of medical rehabilitation is 12-14 days. The total duration of one procedure is 1 hour. In the second group (VR technologies with BFB): 10 procedures, 5 times a week, the duration of the course of medical rehabilitation is 12-14 days. The total duration of one procedure is 30 minutes. In the third group (Complex application of robotic mechanotherapy technologies with FES and VR with biofeedback): 10 procedures, 5 times a week, the duration of the course of medical rehabilitation is 12-14 days. The total duration of training with VR is 30 minutes, then no earlier than 2 hours later, training on an exoskeleton, lasting no more than 1 hour. Patients in the control group will receive comprehensive rehabilitation procedures as prescribed, during the course of treatment accepted in a medical institution.

Conditions

• Ischemic Stroke, Acute

Interventions

DEVICE

technologies of robotic mechanotherapy with FES

Technologies of robotic mechanotherapy with FES (ExoAtlet I): Simulator is designed for rehabilitation in case of motor deficiency of the lower extremities and recovery of walking caused by stroke and other diseases and injuries of the central nervous system. The main components of the simulator are: * exoskeletal robotic device for moving the patient and forming a walking pattern * a device for functional electrical stimulation (FES) of peripheral nerves controlling the muscles of the rehabilitated limb.

DEVICE

biofeedback virtual reality technologies

Brief information biofeedback virtual reality technologies: ReviVR Multisensory Passive Rehabilitation Simulator is intended for rehabilitation in case of motor deficiency of the lower extremities and recovery of walking caused by stroke and other diseases and injuries of the central nervous system. The main components of the simulator are: * hardware and software complex, including a monitor and a personal computer; * virtual reality helmet; * sandals with air chambers.

Sponsors & Collaborators

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

  lead OTHER

Principal Investigators

• Marina MA Rassulova, PhD · Moscow Centre for Research and Practice in Medical Rehabilitation, Restorative and Sports Medicine of Moscow Healthcare Department

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-18

Primary Completion

2023-12-31

Completion

2023-12-31

Countries

• Russia

Study Locations