Standardization of the System of Multimodal Cognitive-motor Poststroke Rehabilitation, in Accordance With the Verification of Rehabilitation Potential, Rehabilitation Diagnosis and Patient Model, at the Stages of Medical Rehabilitation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 405
- 试验地点
- 1
- 主要终点
- ICF motor and sensitive domains dynamic
研究概览
简要总结
The aim of the study is to develop and scientifically substantiate a standardized system of multimodal cognitive-motor rehabilitation and its differentiated application in patients with cerebral stroke, according to verified rehabilitation potential based on the patient's rehabilitation model for the stages of medical rehabilitation, including inpatient-replacement technologies
详细描述
The object of the study The study will include 405 patients (men and women) with the diagnosis of ischemic stroke (IS) in the acute (0-21 day), 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), lower limb (LL), mild or moderate cognitive impairment.
Patients will be randomly assigned to one of 6 experimental groups - 3 main groups of 70 patients each in the acute, early and late recovery period of IS and 3 comparison groups (each of 65 patients) in the acute, early and late recovery periods of IS. The patients in the main and comparison groups will be comparable in age, gender and symptoms.
Each participant of the study will be assigned an ordinal number. Patients of the main groups are planned to undergo a rehabilitation course with standardized 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-2" with EEG registration will be used.
The patients of comparison groups are planned to undergo a rehabilitation course with standart rehabilitation programms depending on the severity of functional and neuropsychological disturbances: kinesiotherapy, physical therapy, occupational therapy, massage.
The study is carried out at the inpatient stage, then patients are transferred to the outpatient stage of rehabilitation or controlled home self-rehabilitation using telemedicine technologies.
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
- None
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, acute (1-21 days), early (22 days- 6 months), late recovery (6-12 months) periods.
- •Supratentorial IS according to MRI of the brain.
- •The severity of UL and LL paresis ranged from a score of 4 to 2 according to the Medical Research Council Scale (MRCS)
- •Spasticity of 3 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
Medical rehabilitation (MR) in acute period of IS-inpatient stage
Devices Patients in acute period of IS receive a course of standart MR-program and in main group - rehabilitation with multimodal correction using and 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, if moderate paresis of the upper limb - the neurointerface "Exokist-2" with EEG registration.
干预措施: Multimodal technology (MT) (Procedure)
Medical rehabilitation (MR) in acute period of IS-inpatient stage
Devices Patients in acute period of IS receive a course of standart MR-program and in main group - rehabilitation with multimodal correction using and 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, if moderate paresis of the upper limb - the neurointerface "Exokist-2" with EEG registration.
干预措施: Conventional rehabilitation (Procedure)
MR in early recovery period of IS- inpatient stage
Devices Patients in the early recovery period of IS receive a course of standart MR-program and in main group - rehabilitation with multimodal correction using and 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, if moderate paresis of the upper limb - the neurointerface "Exokist-2" with EEG registration.
干预措施: Multimodal technology (MT) (Procedure)
MR in early recovery period of IS- inpatient stage
Devices Patients in the early recovery period of IS receive a course of standart MR-program and in main group - rehabilitation with multimodal correction using and 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, if moderate paresis of the upper limb - the neurointerface "Exokist-2" with EEG registration.
干预措施: Conventional rehabilitation (Procedure)
MR in late recovery period of IS-inpatient stage
Devices Patients in the late recovery period of IS receive a course of standart MR-program and in main group - rehabilitation with multimodal correction using and 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, if moderate paresis of the upper limb - the neurointerface "Exokist-2" with EEG registration.
干预措施: Multimodal technology (MT) (Procedure)
MR in late recovery period of IS-inpatient stage
Devices Patients in the late recovery period of IS receive a course of standart MR-program and in main group - rehabilitation with multimodal correction using and 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, if moderate paresis of the upper limb - the neurointerface "Exokist-2" with EEG registration.
干预措施: Conventional rehabilitation (Procedure)
MR in early recovery period of IS - outpatient stage
Devices Patients in the early recovery period of IS receive a course of standart MR-program and in main group - rehabilitation with multimodal correction using and 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, if moderate paresis of the upper limb - the neurointerface "Exokist-2" with EEG registration.
干预措施: Multimodal technology (MT) (Procedure)
MR in early recovery period of IS - outpatient stage
Devices Patients in the early recovery period of IS receive a course of standart MR-program and in main group - rehabilitation with multimodal correction using and 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, if moderate paresis of the upper limb - the neurointerface "Exokist-2" with EEG registration.
干预措施: Conventional rehabilitation (Procedure)
MR in late recovery period of IS - outpatient stage
Devices Patients in the late recovery period of IS receive a course of standart MR-program and in main group - rehabilitation with multimodal correction using and 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, if moderate paresis of the upper limb - the neurointerface "Exokist-2" with EEG registration.
干预措施: Multimodal technology (MT) (Procedure)
MR in late recovery period of IS - outpatient stage
Devices Patients in the late recovery period of IS receive a course of standart MR-program and in main group - rehabilitation with multimodal correction using and 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, if moderate paresis of the upper limb - the neurointerface "Exokist-2" with EEG registration.
干预措施: Conventional rehabilitation (Procedure)
结局指标
主要结局
ICF motor and sensitive domains dynamic
时间窗: Baseline, visit day 10 of inpatient rehabilitation, visit days 1, 7, 15 of MR in outpatient stage
Changes in the severity of dysfunctions by at least 1 determinant point of at least 1 of the selected ICF domains characterizing motor stereotype, balance at rest and when walking, fine motor skills of the upper limb, sensory disorders, pain syndrome
次要结局
- Changes in level of impairment or dependence in daily life(Baseline, visit day 10 of inpatient rehabilitation, visit days 1, 7, 15 of MR in outpatient stage)
- ICF cognitive and emotional domains dynamic(Baseline, visit day 10 of inpatient rehabilitation, visit days 1, 7, 15 of MR in outpatient stage)
- Canges in Rehabilitation routing scale (RRS)(Baseline, visit day 10 of inpatient rehabilitation, visit days 1, 7, 15 of MR in outpatient stage)
- Changes of Life quality assessment(Baseline, visit day 10 of inpatient rehabilitation, visit days 1, 7, 15 of MR in outpatient stage)
- Changes in Rankin scale(Baseline, visit day 10 of inpatient rehabilitation, visit days 1, 7, 15 of MR in outpatient stage)
- Changes of SF-36 questionnaire(Baseline, visit day 10 of inpatient rehabilitation, visit days 1, 7, 15 of MR in outpatient stage)
研究者
Nadezda Lyamina
Clinical Professor
Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine