Ischemic Stroke
Conditions
Keywords
tDCS, stroke, postural control
Brief summary
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
Detailed description
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.
Interventions
DEVICETranscranial direct current stimulation (tDCS)
Participants underwent tDCS(2mA) brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days,for 1 week.
DEVICESham
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.
Sponsors
Shahid Beheshti University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postural control | After 5 days | Functional dynamic balance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Static Balance | After 5 days | linear analysis |
| Change of Static Balance | 1 week | linear analysis |
Other
| Measure | Time frame | Description |
|---|---|---|
| Postural sway flactuation | After 5 days | nonlinear (Approximate entropy) analysis |
| Change of Postural control | 1 week | Functional dynamic balance |
Countries
Iran
Contacts
Primary ContactFariba Yadolahi, MD-PhD Candidate
Outcome results
None listed