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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change from Baseline in Tinetti test
研究概览
简要总结
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.
详细描述
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.
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
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged 45 to 70 years after a first-onset IS, early (1-6 months), late recovery (6-12 months) periods.
- •Supratentorial IS according to MRI of the brain.
- •The severity of UL paresis ranged from a score of 4 to 3 according to the Medical Research Council Scale (MRCS).20
- •Spasticity of 2 points or less by the Modified Ashworth Scale (MAS)
- •Cognitive function more than 20 points on the Montreal Cognitive Assessment (MoCA)
- •Affective disorders score less than 11 on the Hospital Anxiety and Depression Scale (HADS)
- •The patient's ability and willingness to comply with the requirements of this protocol.
排除标准
- •Concomitant neurological diseases causing decreased muscle strength or increased muscle tone in the UL (e.g., cerebral palsy, brain injury).
- •Clinically significant limitation of the passive movement amplitude in the joints of the investigated hand, pronounced contracture and deformities of the upper extremity.
- •Use of other DIT, BFB techniques to restore impaired UL function within 30 days prior to the patient Inclusion Visit.
- •Severe visual impairment, decreased visual acuity of less than 0.2 in the worst eye according to the Golovin-Sivtsev Table
- •Sensory aphasia, gross motor aphasia.
- •Recurrent stroke.
- •Unstable angina and/or heart attack in previous month.
- •Uncontrolled arterial hypertension.
- •Somatic diseases in decompensation stage.
- •Thrombosis of deep and superficial veins of the lower extremities
- •The presence of left-handedness in the patient according to the Edinburgh manual asymmetry questionnaire
- •Alcohol abuse, medical marijuana use or soft drug abuse within the 12 months prior to the Inclusion Visit.
- •Any medical condition, including mental disease or epilepsy that could affect the interpretation of study results, the study procedures or patient safety.
- •15 Pregnancy.
研究组 & 干预措施
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.
干预措施: Multimodal technology (MT) (Other)
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.
干预措施: Multimodal technology (MT) (Other)
No MT Intervention: Conventional IS rehabilitation
Patients in early and late recovery period of IS recieve conventional complex rehabilitation: kinesiotherapy, physiotherapy, occupational therapy.
干预措施: Conventional rehabilitation (CR) (Other)
结局指标
主要结局
Change from Baseline in Tinetti test
时间窗: Baseline, day 7, day 15 of MT and 6 weeks 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.
Changes in cognitive status
时间窗: Baseline, day 7, day 15 of MT and 6 weeks after completing training
Assesment by the Montreal Cognitive Assessment scale (МоСА). MoCA is scored out of 30. A cut-off score of 26 signifies mild cognitive impairment.
Change from Baseline in 10 Metre Walk Test
时间窗: Baseline, day 7, day 15 of MT and 6 weeks after completing training
The individual walks without assistance for 10 meters, with the time measured for the intermediate 6 meters to allow for acceleration and deceleration. The total time taken to ambulate 6 meters is recorded Timing starts when the toes pass the 2-meter mark Timing stops when the toes pass the 8-meter mark
Fugl-Meyer Upper Extremity Scale (FMA-UE) dynamic
时间窗: Baseline, day 7, day 15 of MT and 6 weeks after completing training
The FMA UE Scale comprises 33 items, each scored on a scale of0 to 2, where 0 = cannot perform, 1 = performs partially and2 = performs fully. It is free, requires only household items fortesting, and takes up to 30 minutes to administer. Changes in sections A-D of the FMA-UE Scale by 7 points or more are considered as efficacy.
Restoration of CNS function
时间窗: Baseline, day 15 of MT
Concentration of human brain neurotrophic factor (BDNF) in the blood serum of patients by solid-phase enzyme immunoassay
Action Research Arm Test (ARAT) Scale dynamic
时间窗: Baseline, day 7, day 15 of MT and 6 weeks after completing training
The Action Research Arm Test (ARAT) is a 19 item observational measures. Items comprising the ARAT are categorized into four subscales (grasp, grip, pinch and gross movement) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally). Changes in the total ARAT Scale score by 4 points or more more are considered as efficacy.
Change from Baseline of Presence and severity of depression and anxiety
时间窗: Baseline, day 7, day 15 of MT and 6 weeks after completing training
The Hospital Anxiety and Depression Scale (HADS). Changes in HADS anxiety and depression scores.The HADS is a fourteen item scale that generates: Seven of the items relate to anxiety and seven relate to depression.Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.8-10 - points subclinically expressed anxiety / depression 11 points and above - clinically expressed anxiety / depression.
次要结局
- Canges in Rehabilitation routing scale.(Baseline, day 15 of MT and 6 weeks after completing training)
- change in the paresis degree ин the 6-point Medical Research Council Scale for assessing muscle strength: MRCS(Baseline, day 7, day 15 of MT and 6 weeks after completing training)
- Percentage of correctly performed tasks(Baseline, day 7, day 15)
- Changes in spasticity severity(Baseline, day 7, day 15 of MT and 6 weeks after completing training)
- Changes of Life quality assessment(Baseline, day 7, day 15 of MT and 6 weeks after completing training)
- Changes in level of impairment or dependence in daily life(Baseline, day 7, day 15 of MT and 6 weeks after completing training)
- Changes by international scale of functioning, disability and health (ISF)(Baseline, day 15 of MT and 6 weeks after completing training)