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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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).
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Alexander Zakharov, MD
- 전화번호: +79171620301
- 이메일: a.v.zaharov@samsmu.ru
연구 연락처 백업
- 이름: Yulia Minina, MD
- 전화번호: +79171195502
연구 장소
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Russia
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Samara, Russia, 러시아 제국, 443095
- Samara City Clinical Hospital No. 2 named after N.A. Semashko
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연락하다:
- Alexander Zakharov
- 전화번호: +79171620301
- 이메일: a.v.zaharov@samsmu.ru
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 더블
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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. |
|
활성 비교기: 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. |
|
활성 비교기: 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. |
|
가짜 비교기: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from Baseline in Berg Balance Scale (BBS)
기간: 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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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from Baseline in Berg Balance Scale (BBS) at Day 6
기간: 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)
기간: Day 0, Day 6, Day 12
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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
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Change from Baseline in Morse Fall Scale (MFS)
기간: Day 0, Day 6, Day 12
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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
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Change from Baseline in Hauser Ambulation Index (HAI)
기간: Day 0, Day 6, Day 12
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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)
기간: Day 0, Day 6, Day 12
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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)
기간: 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)
기간: Day 0, Day 6, Day 12
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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
기간: Day 0, Day 6, Day 12
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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)
기간: 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
기간: Day 0 through Day 12
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Adverse events related to stabilometry or tDCS (e.g., skin irritation, headache, dizziness, falls, seizures), recorded at each session. |
Day 0 through Day 12
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
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연구 완료
연구 등록 날짜
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연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
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추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- SamSMU-BEC-322-2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Anonymized individual participant data underlying the published results (baseline characteristics and outcome scores).
IPD 공유 기간
Beginning at publication of the main results, available for 5 years
IPD 공유 액세스 기준
Available as supporting information with the journal article; other requests to the Principal Investigator with a methodologically sound proposal
IPD 공유 지원 정보 유형
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