Dynamic Stabilometry Combined With Transcranial Direct Current Stimulation for Balance and Motor Recovery After Ischemic Stroke (STAB-tDCS)
Efficacy of Combined Dynamic Stabilometry and Transcranial Electrical Stimulation in the Early Recovery Period of Ischemic Stroke in Patients With Hemiparesis: a Single-Center Randomized Study
The goal of this clinical trial is to learn if balance training on a moving (dynamic) platform with visual and sound feedback, combined with weak electrical brain stimulation, helps people recover balance and movement after an ischemic stroke with weakness on one side of the body (hemiparesis).
The main questions it aims to answer are:
- Does the combination of dynamic platform training and active brain stimulation improve balance more than either method alone?
- Does it improve independence in daily activities, mobility and walking, and reduce fall risk?
- Is the combined treatment safe in the early period after stroke? Researchers will compare four groups: dynamic platform training with active stimulation, dynamic platform training with sham (imitation) stimulation, training on a locked (static) platform with active stimulation, and training on a locked platform with sham stimulation.
Participants will:
- Receive standard rehabilitation (exercise therapy and physiotherapy) of the same volume in all groups.
- Complete 10 sessions of 20-minute platform training over 12 days (5 sessions per week), with active or sham brain stimulation during each session.
- Have balance, mobility and neurological tests on Day 0, Day 6 and Day 12.
Обзор исследования
Статус
Подробное описание
Background and Rationale. Stroke is a leading cause of long-term disability. Motor impairment, primarily hemiparesis, occurs in 60-80% of stroke survivors and limits functional independence and quality of life. The early recovery period (7-30 days after stroke onset) is characterized by enhanced neuroplasticity and is considered an optimal window for intensive rehabilitation.
Dynamic stabilometry with biofeedback is active postural control training: the patient receives real-time visual and auditory information on the position of the center of pressure while balancing on a moving platform. Unlike static stabilometry, the dynamic mode creates a controlled sensory load on the postural system and engages adaptive cerebellar-cortical mechanisms. Anodal transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) increases cortical excitability and may potentiate motor learning. tDCS combined with active motor training has shown synergistic effects, but its combination with dynamic stabilometry has not been studied.
Interventions. Dynamic stabilometry is performed on the ReviStabix stabilometric trainer (Samara State Medical University; Russian medical device registration No. G004-00110-00/03075665 of August 29, 2025) in dynamic mode with visual and auditory biofeedback, at a fixed standard platform angle. In the control condition the platform is locked (static mode). tDCS is delivered with the Neurostim device (Neurosoft, Russia; registration certificate No. RZN 2021/13529 of February 20, 2021): anodal stimulation, 2 mA, electrode area 35 cm², 20 minutes; anode over M1, cathode over the supraorbital area. Stimulation starts simultaneously with the stabilometry session. Sham tDCS uses the same electrode montage; current is delivered for the first 30 seconds and then switched off automatically.
Study Design and Participant Groups. This is a prospective, single-center, pilot randomized controlled trial with a 2×2 factorial design (dynamic vs static stabilometry × active vs sham tDCS). A total of 120 patients aged 30-85 years with ischemic stroke and mild to moderate hemiparesis will be randomized 1:1:1:1 into four groups of 30: (A) dynamic stabilometry + active tDCS; (B) dynamic stabilometry + sham tDCS; (C) static stabilometry + active tDCS; (D) static stabilometry + sham tDCS. Randomization is in blocks of 8, stratified by age (<65 / ≥65 years) and side of the lesion (left / right hemisphere), with allocation concealment by sealed opaque envelopes or centralized web-based randomization. Participants are blinded to the type of stimulation (active / sham), and outcome assessors are blinded to group allocation.
What Participation Involves. All groups receive standard rehabilitation of equal volume (exercise therapy, physiotherapy), recorded in a session log. The study course consists of 10 sessions of 20 minutes over 12 days (5 sessions per week on weekdays). Assessments are performed at baseline (Day 0), Day 6 and Day 12: Berg Balance Scale (primary outcome), Functional Independence Measure, Morse Fall Scale, Hauser Ambulation Index, modified Rankin Scale, Rivermead Mobility Index, National Institutes of Health Stroke Scale, Medical Research Council muscle strength scale and Modified Ashworth Scale. Adverse events are recorded throughout the course.
Statistical Analysis. The primary analysis is ANCOVA of Day 12 BBS adjusted for baseline BBS, in the intention-to-treat population. Mixed ANOVA is used for changes across Day 0, 6 and 12, and 2×2 factorial ANOVA to test the interaction (dynamic stabilometry × tDCS). Effect sizes are expressed as Cohen's d; α = 0.05, power 80%. Sample size assumes an expected BBS difference of 6 points (SD 10, d = 0.6).
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Alexander Zakharov, MD
- Номер телефона: +79171620301
- Электронная почта: a.v.zaharov@samsmu.ru
Учебное резервное копирование контактов
- Имя: Yulia Minina, MD
- Номер телефона: +79171195502
Места учебы
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Russia
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Samara, Russia, Россия, 443095
- Samara City Clinical Hospital No. 2 named after N.A. Semashko
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Контакт:
- Alexander Zakharov
- Номер телефона: +79171620301
- Электронная почта: a.v.zaharov@samsmu.ru
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Ischemic stroke verified by neuroimaging (computed tomography or magnetic resonance imaging)
- Mild or moderate hemiparesis
- Time since stroke onset from 7 days to 6 months
- Ability to stand with support for at least 30 seconds
- Age 30 to 85 years
- Mini-Mental State Examination (MMSE) score ≥ 20
- Medical stability (no acute somatic complications)
- Signed informed consent
Exclusion Criteria:
- Hemorrhagic stroke
- History of epilepsy or seizures
- Intracranial metal implants or cardiac pacemaker
- Severe aphasia preventing understanding of instructions
- Marked vestibular dysfunction (Meniere's disease, benign paroxysmal positional vertigo in exacerbation)
- Severe visual impairment preventing use of visual biofeedback
- Severe lower limb spasticity (Modified Ashworth Scale ≥ 3)
- Severe concomitant orthopedic disorders preventing verticalization
- Unstable somatic condition (heart failure NYHA class III-IV, unstable angina, blood pressure > 180/110 mm Hg)
- Recurrent stroke within the last 3 months
- MMSE score < 20
- Scalp diseases in the electrode placement areas
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Факторное присвоение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Experimental Arm A: Dynamic stabilometry + Active tDCS
Standard rehabilitation plus dynamic stabilometry with visual and auditory biofeedback (20 min) synchronized with active anodal tDCS over M1 (2 mA, 20 min); 10 sessions, 5 times/week, over 12 days. |
Active balance training on a stabilometric platform in dynamic mode with real-time visual and auditory feedback on the center of pressure; fixed standard platform angle; 20-min sessions. Anodal transcranial direct current stimulation, 2 mA, electrode area 35 cm², 20 min; anode over M1, cathode over the supraorbital area; starts simultaneously with the stabilometry session. Exercise therapy and physiotherapy of equal volume in all groups, recorded in a session log. |
|
Активный компаратор: Control Arm B: Dynamic stabilometry + Sham tDCS
Standard rehabilitation plus dynamic stabilometry with biofeedback (20 min) with sham tDCS (current for the first 30 s only); 10 sessions, 5 times/week, over 12 days. |
Active balance training on a stabilometric platform in dynamic mode with real-time visual and auditory feedback on the center of pressure; fixed standard platform angle; 20-min sessions. Exercise therapy and physiotherapy of equal volume in all groups, recorded in a session log. Same electrode montage as active tDCS; current delivered for the first 30 s to mimic skin sensations, then switched off automatically. |
|
Активный компаратор: Control Arm C: Static stabilometry + Active tDCS
Standard rehabilitation plus training on the locked (static) platform (20 min) synchronized with active anodal tDCS over M1 (2 mA, 20 min); 10 sessions, 5 times/week, over 12 days. |
Anodal transcranial direct current stimulation, 2 mA, electrode area 35 cm², 20 min; anode over M1, cathode over the supraorbital area; starts simultaneously with the stabilometry session. Exercise therapy and physiotherapy of equal volume in all groups, recorded in a session log. Training on the same stabilometric platform with the platform locked (static mode), same session duration; controls for the dynamic platform component. |
|
Фальшивый компаратор: Control Arm D: Static stabilometry + Sham tDCS
Standard rehabilitation plus training on the locked (static) platform (20 min) with sham tDCS; 10 sessions, 5 times/week, over 12 days. |
Exercise therapy and physiotherapy of equal volume in all groups, recorded in a session log. Same electrode montage as active tDCS; current delivered for the first 30 s to mimic skin sensations, then switched off automatically. Training on the same stabilometric platform with the platform locked (static mode), same session duration; controls for the dynamic platform component. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change from Baseline in Berg Balance Scale (BBS)
Временное ограничение: Baseline (Day 0) and Day 12
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The BBS assesses static and dynamic balance with 14 items; total score ranges from 0 to 56, where higher scores indicate better balance. |
Baseline (Day 0) and Day 12
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change from Baseline in Berg Balance Scale (BBS) at Day 6
Временное ограничение: Baseline (Day 0) and Day 6
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Interim BBS assessment; range 0 to 56, where higher scores indicate better balance. |
Baseline (Day 0) and Day 6
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Change from Baseline in Functional Independence Measure (FIM)
Временное ограничение: Day 0, Day 6, Day 12
|
The FIM assesses the level of assistance needed in daily activities (motor and cognitive domains); total score ranges from 18 to 126, where higher scores indicate greater independence. |
Day 0, Day 6, Day 12
|
|
Change from Baseline in Morse Fall Scale (MFS)
Временное ограничение: Day 0, Day 6, Day 12
|
The MFS estimates fall risk from six items; score ranges from 0 to 125, where higher scores indicate higher fall risk. |
Day 0, Day 6, Day 12
|
|
Change from Baseline in Hauser Ambulation Index (HAI)
Временное ограничение: Day 0, Day 6, Day 12
|
The HAI rates walking ability from 0 (fully active) to 9 (restricted to wheelchair, unable to transfer), where higher scores indicate worse mobility. |
Day 0, Day 6, Day 12
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Change from Baseline in modified Rankin Scale (mRS)
Временное ограничение: Day 0, Day 6, Day 12
|
The mRS measures global disability and dependence; range 0 (no symptoms) to 6 (death), where higher scores indicate greater disability. |
Day 0, Day 6, Day 12
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Change from Baseline in Rivermead Mobility Index (RMI)
Временное ограничение: Day 0, Day 6, Day 12
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The RMI assesses functional mobility with 15 items from turning in bed to running; range 0 to 15, where higher scores indicate better mobility. |
Day 0, Day 6, Day 12
|
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Change from Baseline in National Institutes of Health Stroke Scale (NIHSS)
Временное ограничение: Day 0, Day 6, Day 12
|
The NIHSS quantifies stroke-related neurological deficit; range 0 to 42, where higher scores indicate more severe deficit. |
Day 0, Day 6, Day 12
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Change from Baseline in Medical Research Council (MRC) Muscle Strength Score
Временное ограничение: Day 0, Day 6, Day 12
|
Muscle strength of the paretic limbs graded per muscle group from 0 (no contraction) to 5 (normal strength), where higher scores indicate greater strength. |
Day 0, Day 6, Day 12
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Change from Baseline in Modified Ashworth Scale (MAS)
Временное ограничение: Day 0, Day 6, Day 12
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The MAS measures resistance to passive movement (spasticity) from 0 to 4, where higher scores indicate more severe spasticity. |
Day 0, Day 6, Day 12
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Number of Participants With Adverse Events
Временное ограничение: Day 0 through Day 12
|
Adverse events related to stabilometry or tDCS (e.g., skin irritation, headache, dizziness, falls, seizures), recorded at each session. |
Day 0 through Day 12
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Неврологические проявления
- Цереброваскулярные расстройства
- Заболевания головного мозга
- Заболевания центральной нервной системы
- Заболевания нервной системы
- Сосудистые заболевания
- Сердечно-сосудистые заболевания
- Инсульт
- Патологические состояния, признаки и симптомы
- Признаки и симптомы
- Ишемический приступ
- Парез
- Терапия
- Терапия разума и тела
- Дополнительная терапия
- Поведенческая терапия
- Психотерапия
- Поведенческие дисциплины и деятельность
- Обратная связь, психологическая
- Электрическая стимуляционная терапия
- Судорожная терапия
- Психиатрическая соматическая терапия
- Электрошок
- Психологические методы
- Транскраниальная стимуляция постоянного тока
- Биологическая обратная связь, психология
Другие идентификационные номера исследования
- SamSMU-BEC-322-2026
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Anonymized individual participant data underlying the published results (baseline characteristics and outcome scores).
Сроки обмена IPD
Beginning at publication of the main results, available for 5 years
Критерии совместного доступа к IPD
Available as supporting information with the journal article; other requests to the Principal Investigator with a methodologically sound proposal
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
Информация о лекарствах и устройствах, исследовательские документы
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