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STAB-tDCSNCT07912151

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

StatusNot Yet Recruiting
PhaseNot applicable
Primary completion (estimated)
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Record History

All 1 version: 1 with changes below.

  1. Study First Submitted

Endpoints

Primary

Change from Baseline in Berg Balance Scale (BBS)
Timeframe: Baseline (Day 0) and Day 12

Secondary (10)

Change from Baseline in Berg Balance Scale (BBS) at Day 6
Change from Baseline in Functional Independence Measure (FIM)
Change from Baseline in Morse Fall Scale (MFS)
Change from Baseline in Hauser Ambulation Index (HAI)
Change from Baseline in modified Rankin Scale (mRS)
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Change from Baseline in Rivermead Mobility Index (RMI)
Change from Baseline in National Institutes of Health Stroke Scale (NIHSS)
Change from Baseline in Medical Research Council (MRC) Muscle Strength Score
Change from Baseline in Modified Ashworth Scale (MAS)
Number of Participants With Adverse Events

Arms and interventions

Experimental Arm A: Dynamic stabilometry + Active tDCSExperimental

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.

Control Arm B: Dynamic stabilometry + Sham tDCSActive comparator

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.

Control Arm C: Static stabilometry + Active tDCSActive comparator

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.

Control Arm D: Static stabilometry + Sham tDCSSham comparator

Standard rehabilitation plus training on the locked (static) platform (20 min) with sham tDCS; 10 sessions, 5 times/week, over 12 days.

Devices: Dynamic Stabilometry With Biofeedback, Static Stabilometry, Anodal tDCS, Sham tDCS

Procedures: Standard Rehabilitation

Sites

1 site in 1 country

  • Samara City Clinical Hospital No. 2 named after N.A. SemashkoSamara, Russia, Russia