Innovative Technologies in Restoring Gait and Balance Functions in Patients in Acute and Early Recovery Periods of Ischemic Stroke at the Inpatient Stage of Medical Rehabilitation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Changes of Life quality assessment
研究概览
简要总结
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.
详细描述
The purpose of the study:
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 technology (VR) 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.
Research objectives:
- To evaluate the effectiveness and safety of the technology of robotic mechanotherapy with FES in the correction of walking and balance disorders in patients in the acute and early recovery periods of ischemic stroke.
- To evaluate the effectiveness and safety of VR technology with BFB in the correction of walking and balance disorders in patients in the acute and early recovery periods of ischemic stroke.
- To evaluate the effectiveness and safety of the integrated application of robotic mechanotherapy technologies with FES and VR with BFB in patients in acute and early recovery periods of ischemic stroke.
- To evaluate the effectiveness and safety of robotic mechanotherapy technologies with FES and BP with BFB in the correction of kinesiophobia in patients in the acute and early recovery periods of ischemic stroke.
- To determine indications and contraindications for the complex application of robotic mechanotherapy technologies with FES and VR with BFB in patients in acute and early recovery periods of ischemic stroke.
- To determine the safety criteria for the use of robotic mechanotherapy technologies with FES and BP with BFB in patients in acute and early recovery periods of ischemic stroke.
- To evaluate the impact of robotic mechanotherapy technologies with FES and VR with BFB on the quality of life of patients in the acute and early recovery periods of ischemic stroke.
- To determine the predictors of recovery of walking and balance disorders in the rehabilitation of patients in the acute and early recovery periods of ischemic stroke based on neurophysiological indicators.
- To develop criteria for evaluating the effectiveness of the use of robotic mechanotherapy technologies with FES and VR with BFB in patients in acute and early recovery periods of ischemic stroke.
- To develop differentiated methods of application of robotic mechanotherapy technologies with FES and VR with BFB for correction of walking and balance disorders in patients in acute and early recovery periods of ischemic stroke.
Implementation into practice:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
排除标准
- •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;
- •Sinus bradycardia (less than 50 beats per minute) and tachycardia (more than 90 beats per minute). At rest and more than 130 beats . in min. under load);
- •Atrioventricular block of I-III degree;
- •Acute venous thrombosis and / or thrombophlebitis of any localization, edema of the lower extremities 2-3 art.
- •Circulatory insufficiency above functional class II according to NYHA
- •Aneurysm of the aorta and cerebral arteries;
- •Hypercoagulation, erythrocytosis.
- •Decompensation of diabetes mellitus.
- •Trophic disorders - bedsores in the places of attachment of the exoskeleton;
- •Epilepsy and other paroxysmal disorders of consciousness;
- •Ankylosis, fixed contractures, deforming arthrosis 3-4 ct, arthritis/synovitis, condition after endoprosthetics, arthroplasty of the joints of the lower extremities;
- •Ungrown fractures or unstable osteosynthesis of the spine, pelvic bones, lower extremities;
- •Instability (subluxations and dislocations) in the joints of the legs
- •Pronounced muscle spasticity (more than 3 points) or significant growth after training;
- •Osteoporosis
- •Systemic connective tissue diseases
- •Malignant tumors.
- •Motor and sensory aphasia
- •Cognitive impairment (less than 26 points on MoCA)
- •Increasing/persistent compression of the spinal cord, its roots, ponytail or ves
结局指标
主要结局
Changes of Life quality assessment
时间窗: Baseline, day 14 after completing training
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.
Hauser Ambulation index dynamic
时间窗: Baseline, day 14 after completing training
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
Change from Baseline in Tinetti test
时间窗: Baseline, day 14 after completing training
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.
The Tampa Scale of Kinesiophobia dynamic
时间窗: Baseline, day 14 after completing training
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.
The Modified Rankin Scale dynamic
时间窗: Baseline, day 14 after completing training
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.
Change in modified Ashworth scale
时间窗: Baseline, day 14 after completing training
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).
The Rivermead Mobility Index dynamic
时间窗: Baseline, day 14 after completing training
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
Change in MRC scale for muscle power
时间窗: Baseline, day 14 after completing training
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.
次要结局
- 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)
- Restoration of the conductive function of the central nervous system(Baseline, day 14 after completing training)
- Change from Baseline of Presence and severity of depression and anxiety(Baseline, day 14 after completing training)