Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

27 ottobre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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).

Tipo di studio

Interventistico

Iscrizione (Stimato)

120

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

  • Nome: Yulia Minina, MD
  • Numero di telefono: +79171195502

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 30 anni a 85 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione fattoriale
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Dispositivo: 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.

Dispositivo: 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.

Procedura: Standard Rehabilitation

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

Procedura: Standard Rehabilitation

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

Dispositivo: Sham tDCS

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

Procedura: Standard Rehabilitation

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

Dispositivo: Static Stabilometry

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

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

Dispositivo: Sham tDCS

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

Dispositivo: Static Stabilometry

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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline in Berg Balance Scale (BBS)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline in Berg Balance Scale (BBS) at Day 6
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Samara State Medical University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

28 ottobre 2026

Completamento primario (Stimato)

28 dicembre 2026

Completamento dello studio (Stimato)

28 dicembre 2026

Date di iscrizione allo studio

Primo inviato

27 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

27 ottobre 2026

Primo Inserito (Effettivo)

3 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • SamSMU-BEC-322-2026

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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

Periodo di condivisione IPD

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

Criteri di accesso alla condivisione IPD

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

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi