Stroke affects upwards of 800,000 Americans every year and has an enormous impact on the well-being of the American Veteran population with 6,000 new stroke admissions every year. Many of these stroke survivors are living with walking disabilities. Gait problems result in inability to function independently, high risk of falls and poor quality of life. Unfortunately, current gait rehabilitation treatments are limited and many stroke survivors do not achieve full recovery. Therefore, it is critical to develop new approaches to enhance gait rehabilitation methods. The investigators propose to evaluate a brain stimulation treatment called transcranial Direct Current Stimulation (tDCS) that can be added to physical therapy. tDCS has been applied for arm rehabilitation after stroke with positive results, but gait-related investigations are lacking. The investigators will test whether simultaneous tDCS and gait training produces greater improvement in walking abilities than gait training alone. Adjunct tDCS therapy may improve outcomes, and reduce cost of both rehabilitation and post-stroke care.
Current rehabilitation methods fail to restore normal gait for many stroke survivors leading to dependence on others, recurrent falls, limitations in community ambulation and poor quality of life. The main objective of this study is to test both efficacy and neurophysiological mechanisms of a novel approach to treat persistent gait deficits after stroke with a combination of simultaneous non-invasive brain stimulation with transcranial Direct Current Stimulation (tDCS) and gait training. The investigators will enroll chronic stroke subjects (\>6 months) with gait deficits. Subjects will be randomized to 10 sessions of either active tDCS+gait training or sham tDCS+gait training. Gait training will be accomplished in the treadmill-based Virtual Reality environment targeting longer single limb stance with the paretic limb. The primary outcome measure will be both gait speed and single limb stance duration. Other outcome measures will assess various components of gait-related functional domains. The study will also characterize neuroplastic brain changes in response to bihemispheric tDCS combined with gait training based on corticospinal excitability using motor evoked potentials and functional connectivity using resting state functional Magnetic Resonance Imaging (rs-fMRI).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
44
Active tDCS is combined with gait therapy. Gait therapy includes gait task practice in Virtual Reality setting and overground gait therapy
Sham tDCS is combined with gait therapy. Gait therapy includes gait task practice in Virtual Reality setting and overground gait therapy
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States
Change in Gait Speed From Baseline (Meters/Second)
Gait speed will be calculated based on Ten Meter Walk Test
Time frame: baseline to post treatment (after 5 weeks of treatment)
Change From Baseline to Post Treatment on Timed up and go (Seconds)
Gait function measure where individuals rise from a chair, walk 3 meters, turn around and return to sitting in the chair
Time frame: baseline to post treatment (after 5 weeks of treatment)
Change From Baseline to Post Treatment in Functional Gait Assessment (Points)
Functional gait measure where individuals walk under different conditions and are scored on a a 4 point scale for performance. 0-30 points; Higher score indicates better outcome
Time frame: baseline to post treatment (after 5 weeks of treatment)
Change From Baseline to Post Treatment on Fugl Meyer Lower Limb
Motor control measure for lower limb after stroke, items rated on a scale of 0-2. A higher score indicates better outcome. score range is 0-34 points.
Time frame: baseline to post treatment (after 5 weeks of treatment)
Change From Baseline to Post Treatment on Gait Assessment and Intervention Tool
Measure of gait coordination after stroke; lower score indicates better coordination; 0-62 points, with lower score indicating better outcome
Time frame: baseline to post treatment (after 5 weeks of treatment)
Change in Asymmetry of Tibialis Anterior Muscle Motor Evoked Potentials From Baseline
Motor Evoked Potential (MEP) is a measure of corticospinal excitability using Transcranial Magnetic Stimulation. We collected maximum MEP from the paretic and non-paretic limbs. Asymmetry of paretic and non-paretic MEPs was calculated as follows: non-paretic minus paretic divided by a sum of paretic and non-paretic. It is expected that therapy reduces asymmetry caused by stroke. We report number of participants with reduced asymmetry of paretic and non-paretic tibialis anterior muscle Motor Evoked Potential.
Time frame: baseline to after 5 weeks of treatment
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