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

NCT05423626 | Unknown

• 1 other identifier: G17032022
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Ischemic Stroke; Acute ischemic stroke; Early recovery period; Exoskeleton; Virtual reality; Biofeedback; Robotic mechanotherapy; Lower limb medical rehabilitation

Outcome Measures

Primary Outcomes (8)

• Changes of Life quality assessment

  European Quality of Life Questionnaire EuroQol EQ-5D-5L (version 1.0, 2011 in combination with the visual analogue scale). Health State: The respondent classifies his or her prevailing state of health by selecting one of three different levels of problem severity within each of five health domains. The levels are none, moderate and severe/extreme (coded 1 through 3, respectively), whilst the domains are mobility, capacity for self-care, conduct of usual activities, pain/discomfort and anxiety/depression, ordered as such. Evaluation: The respondent then evaluates his or her health using a visual analogue scale (VAS). This is a vertical, calibrated, line, bounded at 0 ("worst imaginable health state") and at 100 ("best imaginable health state"). Respondents indicate where they perceive their present state of health to lie, relative to these anchors.

  Baseline, day 14 after completing training

• Hauser Ambulation index dynamic

  The Hauser Ambulation index is a rating scale to assess mobility by evaluating the time and degree of assistance required to walk 25 feet. Scores range from 0 (asymptomatic and fully active) to 10 (bedridden). The patient is asked to walk a marked 25-foot course as quickly and safely as possible. The examiner records the time and type of assistance

  Baseline, day 14 after completing training

• Change from Baseline in Tinetti test

  The Tinetti-test is used to assess the gait and balance, perception of balance and stability during activities of daily living.The Tinetti test has a gait score and a balance score. It uses a 3-point ordinal scale of 0, 1 and 2. Gait is scored over 12 and balance is scored over 16 totalling 28. The lower the score on the Tinetti test, the higher the risk of falling.

  Baseline, day 14 after completing training

• The Rivermead Mobility Index dynamic

  The Rivermead Mobility Index is appropriate for a range of disabilities that include anything from being bedridden to being able to run 15 items: 14-self-reported items 1 direct observation item Items progress in difficulty Items are coded as either 0 or 1, depending on whether the patient can complete the task according to specific instructions Items receive a score of 0 for a "No" response and 1 for a "Yes" response Total scores are determined by summing the points for all items A maximum of 15 points is possible; higher scores indicate better mobility performance. A score of "0" indicates an inability to perform any of the activities on the measure

  Baseline, day 14 after completing training

• The Tampa Scale of Kinesiophobia dynamic

  The Tampa Scale of Kinesiophobia is 17 items a self-reporting questionnaire based on evaluation of fear of movement, fear of physical activity, and fear avoidance. It was first developed to distinguish between non-excessive fear and phobia in patients with chronic musculoskeletal pain, specifically the fear of movement in patients with chronic low back pain then widely used for different parts of the body. The questionnaire using 4 points to assess that are based on; the model of fear-avoidance, fear of work-related activities, fear of movement, and fear of re-injury. The total score of the scale range from 17- 68, where 17 means no kinesiophobia, 68 means severe kinesiophobia, and score ± 37 indicates there is kinesiophobia.

  Baseline, day 14 after completing training

• The Modified Rankin Scale dynamic

  The modified Rankin Scale is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead.

  Baseline, day 14 after completing training

• Change in MRC scale for muscle power

  The muscle scale grades muscle power on a scale of 0 (the worse outcome) to 5 (the best point) in relation to the maximum expected for that muscle.

  Baseline, day 14 after completing training

• Change in modified Ashworth scale

  The modified Ashworth scale (MAS) is the most universally accepted clinical tool used to measure the increase of muscle tone. MAS is a 5 point numerical scale that graded spasticity from 0 to 4. Scoring: 0 No increase in tone (the best point); 4 limb rigid in flexion or extension (the worse outcome).

  Baseline, day 14 after completing training

Secondary Outcomes (5)

• Canges in Rehabilitation routing scale

  Baseline, day 14 after completing training

• Changes by international scale of functioning, disability and health (ISF)

  Baseline, day 14 after completing training

• Changes in cognitive status

  Baseline, day 14 after completing training

• Change from Baseline of Presence and severity of depression and anxiety

  Baseline, day 14 after completing training

• Restoration of the conductive function of the central nervous system

  Baseline, day 14 after completing training

Study Arms (4)

technologies of robotic mechanotherapy with FES

EXPERIMENTAL

In the course of this study, each patient will be given 10 sessions using the ExoAtlet I robotic simulator. The duration of the procedure, according to the patient's condition, is up to 1 hour (taking into account the time for reconfiguring the exoskeleton and positioning the patient). Measurement of pulse, pressure and saturation in the preparatory, main and final parts. The length of stay in an upright position depends on the patient's condition. In order to study and monitor the state of the cardiovascular system during the procedure, the system of remote monitoring of ECG, breathing and movement "Accordis" will be connected. If necessary, a pause is made to rest in a standing or sitting position. The transition to the formation of subsequent skills is recommended after mastering the skills of the previous procedure.

Device: technologies of robotic mechanotherapy with FES

biofeedback virtual reality technologies

EXPERIMENTAL

The group will have 10 classes on a simulator using the technology of virtual reality with biofeedback "ReviVR". The total duration of the procedure is 30 minutes. Before the procedure, blood pressure and heart rate are measured, the size of the pneumatic cuffs on the feet is selected. After instructing the patient and selecting the virtual environment and the optimal speed of movement in VR, VR glasses are installed. Then rehabilitation exercises are carried out for 15 minutes. The patient moves in a virtual environment, receiving visual, auditory and tactile signals that form the correct walking pattern. At the end of the training, the VR glasses are dismantled. Then blood pressure and heart rate are measured and information about the state of health and sensations during the procedure is recorded.

Device: biofeedback virtual reality technologies

Complex application of robotic mechanotherapy technologies with FES and VR with biological feedback

EXPERIMENTAL

The group plans to carry out comprehensive rehabilitation with the use of robotic mechanotherapy and virtual reality with BOS. In this group, patients will first practice for 30 minutes on a VR simulator with a BFB (the duct is identical to group 2), then after 2 hours on an exoskeleton with a FES (the protocol of the lesson is identical to group 1)

Device: technologies of robotic mechanotherapy with FES; Device: biofeedback virtual reality technologies

Control group

NO INTERVENTION

control group with basic course of reabilitation

Interventions

technologies of robotic mechanotherapy with FES DEVICE

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.

Complex application of robotic mechanotherapy technologies with FES and VR with biological feedback; technologies of robotic mechanotherapy with FES

biofeedback virtual reality technologies DEVICE

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.

Complex application of robotic mechanotherapy technologies with FES and VR with biological feedback; biofeedback virtual reality technologies

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Availability of signed informed consent
• Patients with ischemic stroke in the acute and early recovery period, from 5 days to 6 months after the stroke.
• Men and women from 19 to 75 years old.
• The ability to be in a standing position without a pronounced decrease in blood pressure (at least 15 minutes).
• For stroke patients, the score on the scale of muscle strength in the lower extremities is 0-4 points.
• Weight not more than 100 kg
• Height from 160 to 190 cm .
• High motivation for recovery
• Preservation of cognitive functions (at least 27 points on MoCA)
• Rating on the Rankin scale 3-4 points-

You may not qualify if:

• Refusal of the patient to sign an informed consent to participate in the study and refusal to cooperate;
• Inability to be in a standing position (less than 15 minutes), due to pathological vegetative reactions (orthostatic hypotension, tachycardia, bradycardia, arrhythmia, etc.);
• Pregnant, lactating women and women planning pregnancy
• The severity and instability of the somatic condition that prevents verticalization, the presence of contraindications for physical exertion and walking.
• Acute infectious diseases, febrile syndrome;
• Availability of pacemakers;
• Blood pathologies;
• Active form of rheumatism
• Condition after stitching of muscles, tendons, nerves
• Chronic diseases in the decompensation stage;
• Severe vegetative dysreflexia, uncontrolled arterial hypertension (AD system. more than 180 mm Hg, AD diast. more than 100 mm Hg);
• Attacks of angina pectoris at rest or ECG-signs of myocardial ischemia at rest;
• Myocardial infarction less than 6 months ago;
• Heart defects;
• Paroxysmal and persistent form of atrial fibrillation;

Sponsors & Collaborators

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

Study Sites (1)

Moscow Centre for Research and Practice in Medical Rehabilitation, Restorative and Sports Medicine of Moscow Healthcare Department, Branch No. 3

Moscow, 111674, Russia

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Marina MA Rassulova, PhD

  Moscow Centre for Research and Practice in Medical Rehabilitation, Restorative and Sports Medicine of Moscow Healthcare Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gleb GM Lutokhin, PhD

CONTACT

+7(495)706-69-42; gleb.lutokhin@gmail.com

Alim AG Kashezhev, PhD

CONTACT

+7(495)706-69-42; kashezhevalim@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open lable randomized clinical trial

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 21, 2022
• Study Start: March 18, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)