An interventional study of Dynamic Stabilometry With Biofeedback and Static Stabilometry in Hemiparesis, Ischemic Stroke and Stroke Rehabilitation, sponsored by Samara State Medical University. Not yet recruiting at 1 site in Russia. Open to participants aged 30 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Samara State Medical University · Not applicable, Interventional, and Treatment
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:
Participants will:
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).
468 studies on the registry are indexed under Paresis; 117 are open to participants now.
This study's planned enrollment of 120 is above the median of 37 across 420 interventional studies indexed under Paresis.
Browse Paresis studies →Samara State Medical University is the lead sponsor of 19 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Dynamic Stabilometry With Biofeedback · Device: Anodal tDCS · Procedure: Standard Rehabilitation
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.
Device: Dynamic Stabilometry With Biofeedback · Device: Sham tDCS · Procedure: Standard Rehabilitation
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.
Device: Static Stabilometry · Device: Anodal tDCS · Procedure: Standard Rehabilitation
Standard rehabilitation plus training on the locked (static) platform (20 min) with sham tDCS; 10 sessions, 5 times/week, over 12 days.
Device: Static Stabilometry · Device: Sham tDCS · Procedure: Standard Rehabilitation
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.
Training on the same stabilometric platform with the platform locked (static mode), same session duration; controls for the dynamic platform component.
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.
Same electrode montage as active tDCS; current delivered for the first 30 s to mimic skin sensations, then switched off automatically.
Exercise therapy and physiotherapy of equal volume in all groups, recorded in a session log.
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.
Time frame: Baseline (Day 0) and Day 12
Change from Baseline in Berg Balance Scale (BBS) at Day 6
Interim BBS assessment; range 0 to 56, where higher scores indicate better balance.
Time frame: Baseline (Day 0) and Day 6
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.
Time frame: Day 0, Day 6, Day 12
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.
Time frame: Day 0, Day 6, Day 12
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.
Time frame: Day 0, Day 6, Day 12
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.
Time frame: Day 0, Day 6, Day 12
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.
Time frame: Day 0, Day 6, Day 12
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.
Time frame: Day 0, Day 6, Day 12
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.
Time frame: Day 0, Day 6, Day 12
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.
Time frame: Day 0, Day 6, Day 12
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.
Time frame: Day 0 through Day 12
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Anonymized individual participant data underlying the published results (baseline characteristics and outcome scores).
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning at publication of the main results, available for 5 years
Access criteria: Available as supporting information with the journal article; other requests to the Principal Investigator with a methodologically sound proposal
Start is estimated for Oct 2026; primary completion for Dec 2026, 2 months later.
Of 221 non-industry interventional studies with no phase under Paresis, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 55. This study's planned 2 months is below that.
Counting every sponsor, half of 239 studies reached it within 32 months; a quarter within 13 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Samara State Medical University