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Dynamic Stabilometry Combined With Transcranial Direct Current Stimulation for Balance and Motor Recovery After Ischemic Stroke (STAB-tDCS)

27. října 2026 aktualizováno: Alexander Zakharov, Samara State Medical University

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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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).

Typ studie

Intervenční

Zápis (Odhadovaný)

120

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

  • Jméno: Yulia Minina, MD
  • Telefonní číslo: +79171195502

Studijní místa

  • Rusko
    • Russia
      • Samara, Russia, Rusko, 443095
        • Samara City Clinical Hospital No. 2 named after N.A. Semashko
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

30 let až 85 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Faktorové přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Přístroj: Dynamic Stabilometry With Biofeedback

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.

Přístroj: Anodal tDCS

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.

Postup: Standard Rehabilitation

Exercise therapy and physiotherapy of equal volume in all groups, recorded in a session log.
Aktivní komparátor: 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.
Přístroj: Dynamic Stabilometry With Biofeedback

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.

Postup: Standard Rehabilitation

Exercise therapy and physiotherapy of equal volume in all groups, recorded in a session log.

Přístroj: Sham tDCS

Same electrode montage as active tDCS; current delivered for the first 30 s to mimic skin sensations, then switched off automatically.
Aktivní komparátor: 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.
Přístroj: Anodal tDCS

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.

Postup: Standard Rehabilitation

Exercise therapy and physiotherapy of equal volume in all groups, recorded in a session log.

Přístroj: Static Stabilometry

Training on the same stabilometric platform with the platform locked (static mode), same session duration; controls for the dynamic platform component.
Falešný srovnávač: 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.
Postup: Standard Rehabilitation

Exercise therapy and physiotherapy of equal volume in all groups, recorded in a session log.

Přístroj: Sham tDCS

Same electrode montage as active tDCS; current delivered for the first 30 s to mimic skin sensations, then switched off automatically.

Přístroj: Static Stabilometry

Training on the same stabilometric platform with the platform locked (static mode), same session duration; controls for the dynamic platform component.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from Baseline in Berg Balance Scale (BBS)
Časové okno: Baseline (Day 0) and Day 12

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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from Baseline in Berg Balance Scale (BBS) at Day 6
Časové okno: Baseline (Day 0) and Day 6

Interim BBS assessment; range 0 to 56, where higher scores indicate better balance.
Baseline (Day 0) and Day 6
Change from Baseline in Functional Independence Measure (FIM)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Change from Baseline in modified Rankin Scale (mRS)
Časové okno: 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
Change from Baseline in Rivermead Mobility Index (RMI)
Časové okno: Day 0, Day 6, Day 12

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
Change from Baseline in National Institutes of Health Stroke Scale (NIHSS)
Časové okno: 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
Change from Baseline in Medical Research Council (MRC) Muscle Strength Score
Časové okno: 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
Change from Baseline in Modified Ashworth Scale (MAS)
Časové okno: Day 0, Day 6, Day 12

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
Number of Participants With Adverse Events
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Samara State Medical University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

28. října 2026

Primární dokončení (Odhadovaný)

28. prosince 2026

Dokončení studie (Odhadovaný)

28. prosince 2026

Termíny zápisu do studia

První předloženo

27. října 2026

První předloženo, které splnilo kritéria kontroly kvality

27. října 2026

První zveřejněno (Aktuální)

3. listopadu 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

3. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

27. října 2026

Naposledy ověřeno

1. října 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • SamSMU-BEC-322-2026

Plán pro data jednotlivých účastníků (IPD)

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ANO

Popis plánu IPD

Anonymized individual participant data underlying the published results (baseline characteristics and outcome scores).

Časový rámec sdílení IPD

Beginning at publication of the main results, available for 5 years

Kritéria přístupu pro sdílení IPD

Available as supporting information with the journal article; other requests to the Principal Investigator with a methodologically sound proposal

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA

Informace o lécích a zařízeních, studijní dokumenty

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Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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