The Effect of The Five-Session Dual-Transcranial Direct Current Stimulation on Lower-Limb Performance In Sub-Acute Stroke
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mahidol University
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- Timed-up and go test (TUG)
Study Overview
Brief Summary
The aim of the present study is to determine the effect of the five-session dual-tDCS combine with physical therapy on gait performance, balance and lower limbs muscle strength in patients with subacute stroke.
Detailed Description
Stroke is a leading cause of long term disability. The recovery of motor function after stroke is often incomplete, despite classical rehabilitation techniques. In the beginning of the 21st century, transcranial direct current stimulation (tDCS) was introduced as a non-invasive tool to reversibly modulate brain excitability in humans in which a device sends constant low direct current (DC) delivered to the area of interest through the electrodes. Transcranial direct current stimulation (tDCS) has been used in neurorehabilitation to benefit ischemic stroke patients at different stage of stroke especially during acute, sub-acute and chronic phase with positive and safety reports.
After stroke, the excitability of the lesioned hemisphere is decreased and seen like overactive of the excitability of non-lesioned hemisphere. Abnormally high interhemispheric inhibition (IHI) drive from intact to lesioned hemisphere has been reported. The neural plasticity begins in early stages after stroke. Prevent the imbalance IHI and increase the excitability of the lesioned hemisphere in the early phase would be a beneficial for stroke rehabilitation.
Based on the polarity-specific effects, anodal tDCS increases cortical excitability and cathodal tDCS decreases cortical excitability. Transcranial direct current stimulation (tDCS) can be applied in two distinct montages: monocephalic and bi-hemispheric/dual-tDCS (applying two electrodes over both cerebral hemispheres at the same time). To induce post-stroke motor recovery, two different monocephalic montages are typically used: i) to restore excitability in the lesioned hemisphere: anode over the lesioned hemisphere and the cathode as the reference electrode placed over the contra-orbital area ii) to down regulate excitability of the non-lesioned hemisphere and rebalance IHI: cathode over the non-lesioned hemisphere and the anode as the reference electrode. Dual-tDCS can be also applied, permitting simultaneous coupling of excitatory and inhibitory effects on both cortices. There are few evidences showing that tDCS (monocephalic and bi-hemispheric/dual-tDCS) could improve lower limb performance at immediate and at least 3 months. However, there is still unclear effect on gait performance and muscle strength.
Recently, dual-hemisphere tDCS, in which, excites one hemisphere using anodal stimulation and inhibits the other by cathodal stimulation has been described in healthy volunteers to greater enhance hand motor learning compared to uni-hemispheric tDCS. The corresponding tDCS-induced changes were reported in imaging study to involve interhemispheric interactions.
Dual-tDCS has been more recent used in rehabilitation aiming to reduce the inhibition exerted by the non-lesioned hemisphere on the lesioned hemisphere and restore the normal balance of the IHI. Dual-tDCS combined with training or simultaneous occupational/physical therapy has been reported to improve motor skill learning and functions of the paretic upper limb in chronic stroke patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age range 20-75 years
- •First ever-ischemic lesion in the territory of middle cerebral artery or anterior cerebral artery. Diagnostic confirmation will be performed by CT scan or MRI
- •Sub-acute onset (1-6 months after the stroke onset)
- •Able to walk without physical assistance at least 6 meters
Exclusion Criteria
- •All subjects will be excluded from the study if they have:
- •Not cooperative or cannot understand the instruction
- •Clinical unstable such as vital sign unstable (systolic blood pressure (SBP) ≥ 185 mmHg or diastolic blood pressure (DBP) ≥ 110 mmHg (98) and resting heart rate averaging ≥ 100 bpm (99))
- •No clear neurological antecedent history or psychiatric disorder
- •Moderate pain in any joint of both lower limb (Pain Scale (VAS) ≥ 4/10)
- •Unstable medical conditions such as being in the middle of changing medical treatment.
- •Condition that may increase the risk of stimulation such as epilepsy, pregnancy, unexplained headaches, intracranial metal, pacemaker (evaluating by subjective examination).
- •Participate in the other protocol or receive alternative treatment such as transcranial magnetic stimulation within 1 month.
Outcomes
Primary Outcomes
Timed-up and go test (TUG)
Time Frame: 5 minutes
The Timed-up \& Go (TUG) test is a simple and quick functional mobility test that requires a subject to stand up, walk 3 m, turn, walk back, and sit down. The objective of TUG is to determine fall risk and measure the progress of balance, sit to stand, and walking. This test was initially designed for elderly persons, but is used for people with Parkinson, stroke, Alzheimer, CVA, Huntington disease and others The TUG were assessed only 1 trial and participant were performed as comfortable speed. Materials of TUG are One chair with armrest, stopwatch, tape (to mark 3 meters). The patient starts in a seated position. After that the patient stands up upon therapist's command walks 3 meters, turns around, walks back to the chair and sits down. The time stops when the patient is seated and the subject is allowed to use an assistive device. Be sure to document the assistive device used.
Five Times Sit to Stand Test (FTSTS)
Time Frame: 5 minutes
The FTSTS measures the functional strength of the lower limbs. Subjects sat with their arms folded across the chest and their back against the chair's backrest. They were asked to stand up fully and sit down again 5 times as quickly as possible. The test was repeated 3 times The Five-Times-Sit-to-Stand test (FTSTS) is a clinical test that explores postural control and lower limb muscular strength, devised to accommodate patients who can perform the sit-to-stand activity at least five times. As such, it is a test helpful in quantifying a daily transitional movement while also helping to assess fall risk and disability The FTSTS were assessed 2 times and selected score of the best trial. Participants can rest between trials about 2 minutes or as long as they desire to avoid fatigue.
Force distribution measurement (FDM; The WinFDM and platform, Zebris Medical GmbH, Germany)
Time Frame: 15 minutes
Force distribution measurement (FDM) will be used to analyze gait cycle. The platform will be detecting the force and weight bearing when foot's patients contact the platform and calculate gait parameter. This system was used to analyze gait cycle (step length in cm, step time in second, speed in km/h and cadence in step/minute). Participants walked 3 meter per trial on platform and assessed 5 times. The result was selected from average five trials. Participants can rest between trials about 2 minutes or as long as they desired to avoid fatigue.
Secondary Outcomes
- Hand-held dynamometer (HHD)(15 minutes)