An interventional study of Transcranial direct current stimulation (tDCS) and Sham in Ischemic Stroke, sponsored by Shahid Beheshti University of Medical Sciences. Status unknown at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-25.
Sponsored by Shahid Beheshti University of Medical Sciences · Not applicable, Interventional, and Treatment
Purpose:
The incidence of stroke in low-to-middle income countries is increasing .Balance impairment and falling negatively impact function of stroke patients. Mobility is based on successful postural control and about 30% of individuals with stroke are unable to ambulate without assistance.Transcranial direct current stimulation (tDCS) is a new promising tool for motor recovery in neurological disease.This can be addressed through a tDCS intervention.
Objective:The objectives of this study is to examine the efficacy of anodal tDCS combined with Biodex balance training on postural control in chronic stroke patients using laboratory and clinical assessments. The following essential treatment components; a) active tDCS stimulation paired with Biodex balance training, b)sham tDCS paired with Biodex balance training program.
To identify combinations effects of tDCS stimulation plus balance training . Hypothesis: Anodal tDCS targeting leg motor area (CZ) for 5-days plus Biodex balance training, will significantly improve stroke clients' balance and functional mobility.
Double blinded sham -controlled randomized tDCS stimulation Arms Assigned Interventions
Experimental: Arm 1
tDCS brain stimulation and simultaneous balance training
Participants underwent Active tDCS brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days.
No Intervention: Arm 2 Sham tDCS brain stimulation (20 minutes) and simultaneous balance training
Participants underwent tDCS(2mA) brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days, All outcome measures will be measured in 4 time points: pre-test, post-test after 10 sessions of intervention, and after 1 week and 1 months post intervention as follow ups.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Shahid Beheshti University of Medical Sciences is the lead sponsor of 221 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
age ≥18 years; first-ever ischemic stroke; chronic phase of recovery (>6 months); ability to walk 6- meter supported or unsupported; ability to stand at least unsupported for 40-seconds with eyes closed; only ischemic stroke involving middle cerebral artery (MCA) territory confirmed by CT or MRI.
Exclusion Criteria:
Use of any neuro- or psycho-active medications that alters balance; any other neurological conditions or sensory disorders affecting postural control; such as brain tumor, or substance abuse; orthopedic diseases; ongoing/recent (within 3 months) balance rehabilitation.
ARM1: Transcranial direct current stimulation (tDCS) intervention and simultaneous balance training. Participants underwent tDCS(2mA) brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days,for 1 week.
Device: Transcranial direct current stimulation (tDCS)
ARM2: Sham tDCS and simultaneous balance training(20 minutes) for 5 consecutive days,for 1 week.
Device: Sham
Participants underwent tDCS(2mA) brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days,for 1 week.
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 then and simultaneous balance training(20 minutes) for 5 consecutive days,for 1 week.
Postural control
Functional dynamic balance
Time frame: After 5 days
Static Balance
linear analysis
Time frame: After 5 days
Change of Static Balance
linear analysis
Time frame: 1 week
Change of Static Balance
linear analysis
Time frame: 1 month
Postural sway flactuation
nonlinear (Approximate entropy) analysis
Time frame: After 5 days
Postural sway flactuation
nonlinear (Approximate entropy) analysis
Time frame: 1 week
Postural sway flactuation
nonlinear (Approximate entropy) analysis
Time frame: 1 month
Change of Postural control
Functional dynamic balance
Time frame: 1 week
Change of Postural control
Functional dynamic balance
Time frame: 1 month
This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Shahid Beheshti University of Medical Sciences