Spasticity is one of the most common disorders in patients with central nervous system diseases such as stroke. Transcranial direct current stimulation stimulation (tDCS) is a noninvasive tool that can be used to modulate cortical excitability of the leg motor area, and the spinal motor circuits as well.
Objective:The objectives of this study is to examine the efficacy of anodal tDCS combined with Biodex balance training on lower limbs spasticity in chronic stroke patients using laboratory and clinical assessments.
In a randomized, sham-controlled, double-blinded clinical study, hemiplegic chronic stroke patients are randomized to receive active tDCS delivered to lesioned leg motor cortex (CZ) or sham combined with balance training with Biodex balance system.
Experimental group receive tDCS stimulation (2mA) for 20 min, 5 sessions in five days paired with 20 min balance training.
- Transcranial direct current stimulation (tDCS) Device
Other Names: tDCS; Low intensity transcranial DC stimulator; Soterix 1x1 Intervention Desc: Participants underwent tDCS(2mA) brain stimulation for 20 minutes plus balance training for 20 minutes for 5 consecutive days. ARM 1: Kind: Experimental Label: Arm 1:tDCS Description: Transcranial direct current stimulation (tDCS) Participants underwent tDCS(2mA) brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days
- Sham tDCS Device
Intervention Desc: During sham stimulation, the current ramped up for 30 seconds, ramped back down for 30 seconds, and then remained off for the duration of the stimulation plus balance training for 20 minutes for 5 consecutive days. ARM 1: Kind: Experimental Label: Arm 2: Sham tDCS Description: Sham tDCS and simultaneous balance training(20 minutes) for 5 consecutive days
- Allocation: Randomized
- Masking: Double Blind (Subject, Investigator)
- Purpose: Treatment
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Spasticity (Modified Ashworth scale)||After 5 days||Yes|
|Secondary||Motoneuron excitability (H-reflex latency)||After 5 days||Yes|
|Secondary||Motoneuron excitability||After 5 days||Yes|