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HemiparesisSTAB-tDCSNCT07912151

Dynamic Stabilometry Combined With Transcranial Direct Current Stimulation for Balance and Motor Recovery After Ischemic Stroke

A study testing Dynamic Stabilometry With Biofeedback, Static Stabilometry and Anodal tDCS in people with Hemiparesis and Ischemic Stroke, run by Samara State Medical University at 1 site in Russia.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 30 to 85 years
What is being tested?
Dynamic Stabilometry With Biofeedback, Static Stabilometry and Anodal tDCS
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteRussia
Study dates
28 Oct 2026to 28 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Alexander Zakharov, MD contact

+79171620301

a.v.zaharov@samsmu.ru

Yulia Minina, MD contact

+79171195502

Russia1 site
  • Samara City Clinical Hospital No. 2 named after N.A. Semashko

    Samara, Russia, 443095

    Alexander Zakharov, +79171620301, a.v.zaharov@samsmu.ru

Other trials in Russia

About this study

Official title: 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:

Read more
  • 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.
Read the detailed description

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).

Being tested
Dynamic Stabilometry With Biofeedback, Static Stabilometry, Anodal tDCS, Sham tDCS, Standard Rehabilitation
Keywords
dynamic stabilometry, biofeedback, transcranial direct current stimulation, balance training, neuroplasticity, early recovery period
Medical subject headings
Paresis, Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dynamic Stabilometry With BiofeedbackDevice

    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.

  • Static StabilometryDevice

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

  • Anodal tDCSDevice

    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.

  • Sham tDCSDevice

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

  • Standard RehabilitationProcedure or surgery

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

Study groups in NCT07912151
Study groupRoleWhat they receive
Experimental Arm A: Dynamic stabilometry + Active tDCSExperimentalStandard 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.
Receives: Device: Dynamic Stabilometry With Biofeedback; Device: Anodal tDCS; Procedure: Standard Rehabilitation
Control Arm B: Dynamic stabilometry + Sham tDCSActive comparatorStandard 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.
Receives: Device: Dynamic Stabilometry With Biofeedback; Device: Sham tDCS; Procedure: Standard Rehabilitation
Control Arm C: Static stabilometry + Active tDCSActive comparatorStandard 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.
Receives: Device: Static Stabilometry; Device: Anodal tDCS; Procedure: Standard Rehabilitation
Control Arm D: Static stabilometry + Sham tDCSSham comparatorStandard rehabilitation plus training on the locked (static) platform (20 min) with sham tDCS; 10 sessions, 5 times/week, over 12 days.
Receives: Device: Static Stabilometry; Device: Sham tDCS; Procedure: Standard Rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Berg Balance Scale (BBS)

    The BBS assesses static and dynamic balance with 14 items; total score ranges from 0 to 56, where higher scores indicate better balance.

    Measured: Baseline (Day 0) and Day 12

Secondary outcomes (10)
  1. Change from Baseline in Berg Balance Scale (BBS) at Day 6

    Interim BBS assessment; range 0 to 56, where higher scores indicate better balance.

    Measured: Baseline (Day 0) and Day 6

  2. Change from Baseline in Functional Independence Measure (FIM)

    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.

    Measured: Day 0, Day 6, Day 12

  3. Change from Baseline in Morse Fall Scale (MFS)

    The MFS estimates fall risk from six items; score ranges from 0 to 125, where higher scores indicate higher fall risk.

    Measured: Day 0, Day 6, Day 12

  4. Change from Baseline in Hauser Ambulation Index (HAI)

    The HAI rates walking ability from 0 (fully active) to 9 (restricted to wheelchair, unable to transfer), where higher scores indicate worse mobility.

    Measured: Day 0, Day 6, Day 12

  5. Change from Baseline in modified Rankin Scale (mRS)

    The mRS measures global disability and dependence; range 0 (no symptoms) to 6 (death), where higher scores indicate greater disability.

    Measured: Day 0, Day 6, Day 12

  6. Change from Baseline in Rivermead Mobility Index (RMI)

    The RMI assesses functional mobility with 15 items from turning in bed to running; range 0 to 15, where higher scores indicate better mobility.

    Measured: Day 0, Day 6, Day 12

  7. Change from Baseline in National Institutes of Health Stroke Scale (NIHSS)

    The NIHSS quantifies stroke-related neurological deficit; range 0 to 42, where higher scores indicate more severe deficit.

    Measured: Day 0, Day 6, Day 12

  8. Change from Baseline in Medical Research Council (MRC) Muscle Strength Score

    Muscle strength of the paretic limbs graded per muscle group from 0 (no contraction) to 5 (normal strength), where higher scores indicate greater strength.

    Measured: Day 0, Day 6, Day 12

  9. Change from Baseline in Modified Ashworth Scale (MAS)

    The MAS measures resistance to passive movement (spasticity) from 0 to 4, where higher scores indicate more severe spasticity.

    Measured: Day 0, Day 6, Day 12

  10. Number of Participants With Adverse Events

    Adverse events related to stabilometry or tDCS (e.g., skin irritation, headache, dizziness, falls, seizures), recorded at each session.

    Measured: Day 0 through Day 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2026
  2. Study start28 Oct 2026 (estimated)
  3. Primary completion28 Dec 2026 (estimated)
  4. Study completion28 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
2×2 factorial design: dynamic vs static (locked platform) stabilometry × active vs sham anodal tDCS; all groups receive standard rehabilitation of equal volume.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07912151
Sponsor's protocol ID
SamSMU-BEC-322-2026
Acronym
STAB-tDCS
Status last verified
Oct 2026
First submitted
27 Oct 2026
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual participant data underlying the published results (baseline characteristics and outcome scores).

Questions about this trial

What is this clinical trial studying?

A study testing Dynamic Stabilometry With Biofeedback, Static Stabilometry and Anodal tDCS in people with Hemiparesis and Ischemic Stroke, run by Samara State Medical University at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alexander Zakharov, MD (+79171620301, a.v.zaharov@samsmu.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Berg Balance Scale (BBS) (time frame: Baseline (Day 0) and Day 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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