Stroke, IschemicNCT04687033
The Effect of The Ten-Session Dual-tDCS On Lower-Limb Performance in Sub- Acute and Chronic Stroke
A study testing Transcranial direct current stimulation in people with Stroke, Ischemic, run by Mahidol University at 1 site in Thailand.
Trial summary
The present study aims to determine the effect of the ten-session dual tDCS combine with physical therapy on gait performance, balance, and lower limbs muscle strength in patients with subacute and chronic stroke. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jan 2021to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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) or Chronic (6 months - 5 years)
- Able to walk without physical assistance at least 6 meters
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The present study aims to determine the effect of the ten-session dual tDCS combine with physical therapy on gait performance, balance, and lower limbs muscle strength in patients with subacute and chronic stroke.
Read the 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. At 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 a 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 the non-lesioned hemisphere. Abnormally high interhemispheric inhibition (IHI) drive from intact to lesioned hemisphere has been reported. The neural plasticity begins in the early stages after stroke. Prevent the imbalance IHI and increase the excitability of the lesioned hemisphere in the early phase would be 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 the 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. Few evidences are 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 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 recently 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.
Lower-limb functions are commonly disabling after stroke, however, few studies have focused on the effect of tDCS on lower limb functions. A single session of anodal tDCS over the lower limb M1 has been reported to acutely enhance the effect of motor practice of the paretic ankle, force production of the paretic knee extensors, and postural stability in chronic stroke patients. A study showed an improvement in walking speed immediately after a single session of dual-tDCS alone in sub-acute stroke patients.
Based on the previous study, 1-2 mA current intensity of tDCS is usually used for modulating brain activity. The proper current density delivered is between 0.029-0.008 mA/cm 2. The higher current density, the longer-lasting, stronger, and deeper cortical neuron stimulation. Therefore, 2 mA current intensity of tDCS was applied in stroke patients for lower limb performance improvement. Following homologous brain regions, the motor area of lower extremities is in depth and previous studies demonstrated that current intensity 2 mA of tDCS could pass through the lower extremities area of the brain.
Moreover, Tahtis et al, 2013 found that using 2 mA of dual-tDCS could improve walking speed immediately after a single session in sub-acute stroke and Klomjai et al, 2018 found that a single session of dual-tDCS 2 mA with physical therapy in sub-acute stroke immediately improved sit to stand performance greater than physical therapy alone. The mechanisms of action were hypothesized that when stimulation continuously affects neuronal plasticity changes. Therefore, they suggested that further study shall implement more sessions of dual-tDCS combined with physical therapy to improve lower limb performance and determine the long lasting-after effect.
A previous study reported that the 10-consecutive sessions of tDCS were an effective treatment strategy in reducing the risk of falls and improving lower limb functions after a stroke. However, gait ability and lower limb muscle strength were not included in the outcome measures. In this study, the long-lasting effect was demonstrated at least one week to three months. There are evidences that 10 sessions for uni-hemisphere tDCS appeared to improve lower limb motor functions without serious adverse effects in patients with stroke. It is still unclear the effect of multiple sessions of dual-tDCS on gait performance and muscle strength as well as the long-lasting after-effect of multiple sessions of dual-tDCS.
Therefore, the present study aims to investigate the efficacy of ten sessions of dual-tDCS combined with conventional physical therapy on the lower limb functions after stroke in sub-acute. Clinical outcomes for lower limb performance evaluations will consist of muscle strength assessed by hand-held dynamometer, the Time up and go test for lower limb functional performance, Five times sit to stand test for dynamic balance and muscle strength, and the Zebris Force distribution measurement (FDM) for gait analysis.
- Conditions
- Stroke, Ischemic
- Being tested
- Transcranial direct current stimulation
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulationDevice
This instrument will be used to induce post-stroke motor recovery, two different monocephalic montages are typically used to restore excitability in the lesioned hemisphere and to down-regulate excitability of the non-lesioned hemisphere and rebalance Interhemispheric inhibition. each participant will undergo a 20-minute period of tDCS, applied at 2 mA through a pair of saline-soaked surface sponge electrodes (35 cm2).
| Study group | Role | What they receive |
|---|---|---|
| Dual-tDCS & PT | Experimental | Dual tDCS: the anodal tDCS will be applied over the M1 of the lesioned hemisphere, while the cathodal tDCS will be applied over the M1 of the non-lesioned hemisphere for 20 mins before physical therapy (about
1 hour). The current intensity is fixed at 2 mA and the current will flow continuously. Physical therapist will give an intervention program for lower limb performance. Receives: Device: Transcranial direct current stimulation |
| Sham-tDCS & PT | Active comparator | Sham tDCS: the anodal tDCS will be applied over the M1 of the lesioned hemisphere, while the cathodal tDCS will be applied over the M1 of the non-lesioned hemisphere, the current intensity will be 2mA (sham mode). Physical therapist will give an intervention program for lower limb performance. Receives: Device: Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline gait speed at post-intervention
Force distribution measurement (FDM; The WinFDM and platform, Zebris Medical GmbH, Germany) will be used to analyze step length in centimeters (cm).
Participants will walk 3 meters per trial on a platform and be assessed 5 times. The result will be selected from an average of five trials. Participants can rest between trials for about 2 minutes or as long as they desired to avoid fatigue.
Measured: immediately post-intervention
Change from baseline gait speed at 1 week post-intervention
Force distribution measurement (FDM; The WinFDM and platform, Zebris Medical GmbH, Germany) will be used to analyze step length in centimeters (cm).
Participants will walk 3 meters per trial on a platform and be assessed 5 times. The result will be selected from an average of five trials. Participants can rest between trials for about 2 minutes or as long as they desired to avoid fatigue.
Measured: 1 week post-intervention
Change from baseline gait speed at 1 month post-intervention
Force distribution measurement (FDM; The WinFDM and platform, Zebris Medical GmbH, Germany) will be used to analyze step length in centimeters (cm).
Participants will walk 3 meters per trial on a platform and be assessed 5 times. The result will be selected from an average of five trials. Participants can rest between trials for about 2 minutes or as long as they desired to avoid fatigue.
Measured: 1 month post-intervention
Change from baseline gait speed at 2 month post-intervention
Force distribution measurement (FDM; The WinFDM and platform, Zebris Medical GmbH, Germany) will be used to analyze step length in centimeters (cm).
Participants will walk 3 meters per trial on a platform and be assessed 5 times. The result will be selected from an average of five trials. Participants can rest between trials for about 2 minutes or as long as they desired to avoid fatigue.
Measured: 2 month post-intervention
Change from baseline gait speed at 3 month post-intervention
Force distribution measurement (FDM; The WinFDM and platform, Zebris Medical GmbH, Germany) will be used to analyze step length in centimeters (cm).
Participants will walk 3 meters per trial on a platform and be assessed 5 times. The result will be selected from an average of five trials. Participants can rest between trials for about 2 minutes or as long as they desired to avoid fatigue.
Measured: 3 month post-intervention
Secondary outcomes (30)
Change from baseline spatiotemporal gait variable at post-intervention
Force distribution measurement (FDM; The WinFDM and platform, Zebris Medical GmbH, Germany) will be used to analyze step length in centimeters (cm).
Participants will walk 3 meters per trial on a platform and be assessed 5 times. The result will be selected from an average of five trials. Participants can rest between trials for about 2 minutes or as long as they desired to avoid fatigue.
Measured: immediately post-intervention
Change from baseline spatiotemporal gait variable at 1 week
Force distribution measurement (FDM; The WinFDM and platform, Zebris Medical GmbH, Germany) will be used to analyze step length in centimeters (cm).
Participants will walk 3 meters per trial on a platform and be assessed 5 times. The result will be selected from an average of five trials. Participants can rest between trials for about 2 minutes or as long as they desired to avoid fatigue.
Measured: 1 week post-intervention
Change from baseline spatiotemporal gait variable at 1 month
Force distribution measurement (FDM; The WinFDM and platform, Zebris Medical GmbH, Germany) will be used to analyze step length in centimeters (cm).
Participants will walk 3 meters per trial on a platform and be assessed 5 times. The result will be selected from an average of five trials. Participants can rest between trials for about 2 minutes or as long as they desired to avoid fatigue.
Measured: 1 month post-intervention
Change from baseline spatiotemporal gait variable at 2 months
Force distribution measurement (FDM; The WinFDM and platform, Zebris Medical GmbH, Germany) will be used to analyze step length in centimeters (cm).
Participants will walk 3 meters per trial on a platform and be assessed 5 times. The result will be selected from an average of five trials. Participants can rest between trials for about 2 minutes or as long as they desired to avoid fatigue.
Measured: 2 months post-intervention
Change from baseline spatiotemporal gait variable at 3 months
Force distribution measurement (FDM; The WinFDM and platform, Zebris Medical GmbH, Germany) will be used to analyze step length in centimeters (cm).
Participants will walk 3 meters per trial on a platform and be assessed 5 times. The result will be selected from an average of five trials. Participants can rest between trials for about 2 minutes or as long as they desired to avoid fatigue.
Measured: 3 months post-intervention
Change from baseline muscle strength at post-intervention
The hand-held dynamometer (HHD) measures the muscle strength in Newton. The HHD is simple, quantitative evaluation and widely used for measurement of muscle strength. The strength of lower limbs (hip flexor, hip extensor, hip abductor, knee flexor, knee extensor, ankle dorsiflexor and ankle plantarflexor) were assessed by using the hand-held dynamometer. The strength of lower limbs included hip flexor, hip extensor, hip abductor, knee flexor, knee extensor, ankle dorsiflexor and ankle plantarflexor were assessed by using the hand-held dynamometer. Hip flexor,ankle dorsiflexor and ankle plantarflexor was assessed in supine position, knee extensor was assessed in sitting position, hip extensor and knee flexor were assessed in prone position and hip abductor was assessed in side lying position. Each muscle was assessed 2 times and selected score of the best trial. Participants can rest between trials about 1 minute or as long as they desired to avoid fatigue.
Measured: immediately post-intervention
Change from baseline muscle strength at 1 week
The hand-held dynamometer (HHD) measures the muscle strength in Newton. The HHD is simple, quantitative evaluation and widely used for measurement of muscle strength. The strength of lower limbs (hip flexor, hip extensor, hip abductor, knee flexor, knee extensor, ankle dorsiflexor and ankle plantarflexor) were assessed by using the hand-held dynamometer. The strength of lower limbs included hip flexor, hip extensor, hip abductor, knee flexor, knee extensor, ankle dorsiflexor and ankle plantarflexor were assessed by using the hand-held dynamometer. Hip flexor,ankle dorsiflexor and ankle plantarflexor was assessed in supine position, knee extensor was assessed in sitting position, hip extensor and knee flexor were assessed in prone position and hip abductor was assessed in side lying position. Each muscle was assessed 2 times and selected score of the best trial. Participants can rest between trials about 1 minute or as long as they desired to avoid fatigue.
Measured: 1 week post-intervention
Change from baseline muscle strength at 1 month
The hand-held dynamometer (HHD) measures the muscle strength in Newton. The HHD is simple, quantitative evaluation and widely used for measurement of muscle strength. The strength of lower limbs (hip flexor, hip extensor, hip abductor, knee flexor, knee extensor, ankle dorsiflexor and ankle plantarflexor) were assessed by using the hand-held dynamometer. The strength of lower limbs included hip flexor, hip extensor, hip abductor, knee flexor, knee extensor, ankle dorsiflexor and ankle plantarflexor were assessed by using the hand-held dynamometer. Hip flexor,ankle dorsiflexor and ankle plantarflexor was assessed in supine position, knee extensor was assessed in sitting position, hip extensor and knee flexor were assessed in prone position and hip abductor was assessed in side lying position. Each muscle was assessed 2 times and selected score of the best trial. Participants can rest between trials about 1 minute or as long as they desired to avoid fatigue.
Measured: 1 month post-intervention
Change from baseline muscle strength at 2 months
The hand-held dynamometer (HHD) measures the muscle strength in Newton. The HHD is simple, quantitative evaluation and widely used for measurement of muscle strength. The strength of lower limbs (hip flexor, hip extensor, hip abductor, knee flexor, knee extensor, ankle dorsiflexor and ankle plantarflexor) were assessed by using the hand-held dynamometer. The strength of lower limbs included hip flexor, hip extensor, hip abductor, knee flexor, knee extensor, ankle dorsiflexor and ankle plantarflexor were assessed by using the hand-held dynamometer. Hip flexor,ankle dorsiflexor and ankle plantarflexor was assessed in supine position, knee extensor was assessed in sitting position, hip extensor and knee flexor were assessed in prone position and hip abductor was assessed in side lying position. Each muscle was assessed 2 times and selected score of the best trial. Participants can rest between trials about 1 minute or as long as they desired to avoid fatigue.
Measured: 2 months post-intervention
Change from baseline muscle strength at 3 months
The hand-held dynamometer (HHD) measures the muscle strength in Newton. The HHD is simple, quantitative evaluation and widely used for measurement of muscle strength. The strength of lower limbs (hip flexor, hip extensor, hip abductor, knee flexor, knee extensor, ankle dorsiflexor and ankle plantarflexor) were assessed by using the hand-held dynamometer. The strength of lower limbs included hip flexor, hip extensor, hip abductor, knee flexor, knee extensor, ankle dorsiflexor and ankle plantarflexor were assessed by using the hand-held dynamometer. Hip flexor,ankle dorsiflexor and ankle plantarflexor was assessed in supine position, knee extensor was assessed in sitting position, hip extensor and knee flexor were assessed in prone position and hip abductor was assessed in side lying position. Each muscle was assessed 2 times and selected score of the best trial. Participants can rest between trials about 1 minute or as long as they desired to avoid fatigue.
Measured: 3 months post-intervention
Change from baseline FMA-LE at post-intervention
Fugl-Meyer Assessment Lower Extremity
Measured: immediately post-intervention
Change from baseline FMA-LE at 1 week
Fugl-Meyer Assessment Lower Extremity
Measured: 1 week post-intervention
Change from baseline FMA-LE at 1 month
Fugl-Meyer Assessment Lower Extremity
Measured: 1 month post-intervention
Change from baseline FMA-LE at 2 months
Fugl-Meyer Assessment Lower Extremity
Measured: 2 months post-intervention
Change from baseline FMA-LE at 3 months
Fugl-Meyer Assessment Lower Extremity
Measured: 3 months post-intervention
Change from baseline Stroke Impact Scale at post-intervention
A questionnaire with good psychometric properties aims to evaluate stroke patient's quality of life after stroke incident. It composes of 59 items that aim to assesses 8 domains (i.e., the patient's strength, function of the hand, activities of daily living (ADL)/instrumental ADL (IADL), mobility, communication, emotion, memory and thinking, and participation in society. Each item will be scored from 1 to 5. Each domain's score ranges from 0 to 100. The higher scores mean the better self-report in participant's health.
Measured: immediately post-intervention
Change from baseline Stroke Impact Scale at 1 week
A questionnaire with good psychometric properties aims to evaluate stroke patient's quality of life after stroke incident. It composes of 59 items that aim to assesses 8 domains (i.e., the patient's strength, function of the hand, activities of daily living (ADL)/instrumental ADL (IADL), mobility, communication, emotion, memory and thinking, and participation in society. Each item will be scored from 1 to 5. Each domain's score ranges from 0 to 100. The higher scores mean the better self-report in participant's health.
Measured: 1 week post-intervention
Change from baseline Stroke Impact Scale at 1 month
A questionnaire with good psychometric properties aims to evaluate stroke patient's quality of life after stroke incident. It composes of 59 items that aim to assesses 8 domains (i.e., the patient's strength, function of the hand, activities of daily living (ADL)/instrumental ADL (IADL), mobility, communication, emotion, memory and thinking, and participation in society. Each item will be scored from 1 to 5. Each domain's score ranges from 0 to 100. The higher scores mean the better self-report in participant's health.
Measured: 1 month post-intervention
Change from baseline Stroke Impact Scale at 2 months
A questionnaire with good psychometric properties aims to evaluate stroke patient's quality of life after stroke incident. It composes of 59 items that aim to assesses 8 domains (i.e., the patient's strength, function of the hand, activities of daily living (ADL)/instrumental ADL (IADL), mobility, communication, emotion, memory and thinking, and participation in society. Each item will be scored from 1 to 5. Each domain's score ranges from 0 to 100. The higher scores mean the better self-report in participant's health.
Measured: 2 months post-intervention
Change from baseline Stroke Impact Scale at 3 months
A questionnaire with good psychometric properties aims to evaluate stroke patient's quality of life after stroke incident. It composes of 59 items that aim to assesses 8 domains (i.e., the patient's strength, function of the hand, activities of daily living (ADL)/instrumental ADL (IADL), mobility, communication, emotion, memory and thinking, and participation in society. Each item will be scored from 1 to 5. Each domain's score ranges from 0 to 100. The higher scores mean the better self-report in participant's health.
Measured: 3 months post-intervention
Change from baseline Timed-up and go test (TUG) at post-intervention
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 then 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's, stroke, Alzheimer's, CVA, Huntington's disease, and others.
The TUG will be assessed only for 1 trial and participants will be performed at a comfortable speed. Materials of TUG are composed of a chair with armrest, stopwatch, and tape (to mark 3 meters). Participants will start in a seated position. After that, the participant will stand up upon therapist's command, walks 3 meters, turns around, walks back to the chair, and sits down. The time will stop when the participant is seated. Participants are allowed to use an assistive device during performing the task and this will be noted.
Measured: immediately post-intervention
Change from baseline Timed-up and go test (TUG) at 1 week
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 then 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's, stroke, Alzheimer's, CVA, Huntington's disease, and others.
The TUG will be assessed only for 1 trial and participants will be performed at a comfortable speed. Materials of TUG are composed of a chair with armrest, stopwatch, and tape (to mark 3 meters). Participants will start in a seated position. After that, the participant will stand up upon therapist's command, walks 3 meters, turns around, walks back to the chair, and sits down. The time will stop when the participant is seated. Participants are allowed to use an assistive device during performing the task and this will be noted.
Measured: 1 week post-intervention
Change from baseline Timed-up and go test (TUG) at 1 month
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 then 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's, stroke, Alzheimer's, CVA, Huntington's disease, and others.
The TUG will be assessed only for 1 trial and participants will be performed at a comfortable speed. Materials of TUG are composed of a chair with armrest, stopwatch, and tape (to mark 3 meters). Participants will start in a seated position. After that, the participant will stand up upon therapist's command, walks 3 meters, turns around, walks back to the chair, and sits down. The time will stop when the participant is seated. Participants are allowed to use an assistive device during performing the task and this will be noted.
Measured: 1 month post-intervention
Change from baseline Timed-up and go test (TUG) at 2 months
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 then 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's, stroke, Alzheimer's, CVA, Huntington's disease, and others.
The TUG will be assessed only for 1 trial and participants will be performed at a comfortable speed. Materials of TUG are composed of a chair with armrest, stopwatch, and tape (to mark 3 meters). Participants will start in a seated position. After that, the participant will stand up upon therapist's command, walks 3 meters, turns around, walks back to the chair, and sits down. The time will stop when the participant is seated. Participants are allowed to use an assistive device during performing the task and this will be noted.
Measured: 2 months post-intervention
Change from baseline Timed-up and go test (TUG) at 3 months
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 then 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's, stroke, Alzheimer's, CVA, Huntington's disease, and others.
The TUG will be assessed only for 1 trial and participants will be performed at a comfortable speed. Materials of TUG are composed of a chair with armrest, stopwatch, and tape (to mark 3 meters). Participants will start in a seated position. After that, the participant will stand up upon therapist's command, walks 3 meters, turns around, walks back to the chair, and sits down. The time will stop when the participant is seated. Participants are allowed to use an assistive device during performing the task and this will be noted.
Measured: 3 months post-intervention
Change from baseline Five Times Sit to Stand Test (FTSTS) at post-intervention
The Five-Times-Sit-to-Stand test (FTSTS) measures the functional strength of the lower limbs. It is a clinical test that explores postural control and lower limbs muscular strength, devised to accommodate patients who can perform the sit-to-stand activity at least five times. As such, it is a helpful test in quantifying a daily transitional movement while also helping to assess fall risk and disability.
Participants will sit with their arms folded across the chest and their back against the chair's backrest. They will be asked to stand up fully and sit down again 5 times as quickly as possible. The test will be repeated 2 times. Participants will be allowed to rest between trials for about 2 minutes or as long as they desire to avoid fatigue. The score will be selected from the best trial.
Measured: immediately post-intervention
Change from baseline Five Times Sit to Stand Test (FTSTS) at 1 week
The Five-Times-Sit-to-Stand test (FTSTS) measures the functional strength of the lower limbs. It is a clinical test that explores postural control and lower limbs muscular strength, devised to accommodate patients who can perform the sit-to-stand activity at least five times. As such, it is a helpful test in quantifying a daily transitional movement while also helping to assess fall risk and disability.
Participants will sit with their arms folded across the chest and their back against the chair's backrest. They will be asked to stand up fully and sit down again 5 times as quickly as possible. The test will be repeated 2 times. Participants will be allowed to rest between trials for about 2 minutes or as long as they desire to avoid fatigue. The score will be selected from the best trial.
Measured: 1 week post-intervention
Change from baseline Five Times Sit to Stand Test (FTSTS) at 1 month
The Five-Times-Sit-to-Stand test (FTSTS) measures the functional strength of the lower limbs. It is a clinical test that explores postural control and lower limbs muscular strength, devised to accommodate patients who can perform the sit-to-stand activity at least five times. As such, it is a helpful test in quantifying a daily transitional movement while also helping to assess fall risk and disability.
Participants will sit with their arms folded across the chest and their back against the chair's backrest. They will be asked to stand up fully and sit down again 5 times as quickly as possible. The test will be repeated 2 times. Participants will be allowed to rest between trials for about 2 minutes or as long as they desire to avoid fatigue. The score will be selected from the best trial.
Measured: 1 month post-intervention
Change from baseline Five Times Sit to Stand Test (FTSTS) at 2 months
The Five-Times-Sit-to-Stand test (FTSTS) measures the functional strength of the lower limbs. It is a clinical test that explores postural control and lower limbs muscular strength, devised to accommodate patients who can perform the sit-to-stand activity at least five times. As such, it is a helpful test in quantifying a daily transitional movement while also helping to assess fall risk and disability.
Participants will sit with their arms folded across the chest and their back against the chair's backrest. They will be asked to stand up fully and sit down again 5 times as quickly as possible. The test will be repeated 2 times. Participants will be allowed to rest between trials for about 2 minutes or as long as they desire to avoid fatigue. The score will be selected from the best trial.
Measured: 2 months post-intervention
Change from baseline Five Times Sit to Stand Test (FTSTS) at 3 months
The Five-Times-Sit-to-Stand test (FTSTS) measures the functional strength of the lower limbs. It is a clinical test that explores postural control and lower limbs muscular strength, devised to accommodate patients who can perform the sit-to-stand activity at least five times. As such, it is a helpful test in quantifying a daily transitional movement while also helping to assess fall risk and disability.
Participants will sit with their arms folded across the chest and their back against the chair's backrest. They will be asked to stand up fully and sit down again 5 times as quickly as possible. The test will be repeated 2 times. Participants will be allowed to rest between trials for about 2 minutes or as long as they desire to avoid fatigue. The score will be selected from the best trial.
Measured: 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start1 Jan 2021
- Primary completion30 Nov 2023
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wanalee Klomjai, PhD, Study director, MU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687033
- Sponsor's protocol ID
- MU-CIRB 2019
- Status last verified
- Nov 2025
- First submitted
- 9 Dec 2020
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of The Ten-Session Dual-tDCS On Lower-Limb Performance in Sub- Acute and Chronic Stroke
- ClinicalTrials.gov ID
- NCT04687033
- Acronym / sponsor ID
- MU-CIRB 2019
- Conditions
- Stroke, Ischemic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 29 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study aims to determine the effect of the ten-session dual tDCS combine with physical therapy on gait performance, balance, and lower limbs muscle strength in patients with subacute and chronic 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. At 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 a 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 the non-lesioned hemisphere. Abnormally high interhemispheric inhibition (IHI) drive from intact to lesioned hemisphere has been reported. The neural plasticity begins in the early stages after stroke. Prevent the imbalance IHI and increase the excitability of the lesioned hemisphere in the early phase would be 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 the 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. Few evidences are 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 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 recently 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.
Lower-limb functions are commonly disabling after stroke, however, few studies have focused on the effect of tDCS on lower limb functions. A single session of anodal tDCS over the lower limb M1 has been reported to acutely enhance the effect of motor practice of the paretic ankle, force production of the paretic knee extensors, and postural stability in chronic stroke patients. A study showed an improvement in walking speed immediately after a single session of dual-tDCS alone in sub-acute stroke patients.
Based on the previous study, 1-2 mA current intensity of tDCS is usually used for modulating brain activity. The proper current density delivered is between 0.029-0.008 mA/cm 2. The higher current density, the longer-lasting, stronger, and deeper cortical neuron stimulation. Therefore, 2 mA current intensity of tDCS was applied in stroke patients for lower limb performance improvement. Following homologous brain regions, the motor area of lower extremities is in depth and previous studies demonstrated that current intensity 2 mA of tDCS could pass through the lower extremities area of the brain.
Moreover, Tahtis et al, 2013 found that using 2 mA of dual-tDCS could improve walking speed immediately after a single session in sub-acute stroke and Klomjai et al, 2018 found that a single session of dual-tDCS 2 mA with physical therapy in sub-acute stroke immediately improved sit to stand performance greater than physical therapy alone. The mechanisms of action were hypothesized that when stimulation continuously affects neuronal plasticity changes. Therefore, they suggested that further study shall implement more sessions of dual-tDCS combined with physical therapy to improve lower limb performance and determine the long lasting-after effect.
A previous study reported that the 10-consecutive sessions of tDCS were an effective treatment strategy in reducing the risk of falls and improving lower limb functions after a stroke. However, gait ability and lower limb muscle strength were not included in the outcome measures. In this study, the long-lasting effect was demonstrated at least one week to three months. There are evidences that 10 sessions for uni-hemisphere tDCS appeared to improve lower limb motor functions without serious adverse effects in patients with stroke. It is still unclear the effect of multiple sessions of dual-tDCS on gait performance and muscle strength as well as the long-lasting after-effect of multiple sessions of dual-tDCS.
Therefore, the present study aims to investigate the efficacy of ten sessions of dual-tDCS combined with conventional physical therapy on the lower limb functions after stroke in sub-acute. Clinical outcomes for lower limb performance evaluations will consist of muscle strength assessed by hand-held dynamometer, the Time up and go test for lower limb functional performance, Five times sit to stand test for dynamic balance and muscle strength, and the Zebris Force distribution measurement (FDM) for gait analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual-tDCS & PT | Experimental | Device: Transcranial direct current stimulationDual tDCS: the anodal tDCS will be applied over the M1 of the lesioned hemisphere, while the cathodal tDCS will be applied over the M1 of the non-lesioned hemisphere for 20 mins before physical therapy (about 1 hour). The current intensity is fixed at 2 mA and the current will flow continuously. Physical therapist will give an intervention program for lower limb performance. |
| Sham-tDCS & PT | Active comparator | Device: Transcranial direct current stimulationSham tDCS: the anodal tDCS will be applied over the M1 of the lesioned hemisphere, while the cathodal tDCS will be applied over the M1 of the non-lesioned hemisphere, the current intensity will be 2mA (sham mode). Physical therapist will give an intervention program for lower limb performance. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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) or Chronic (6 months - 5 years)
- Able to walk without physical assistance at least 6 meters
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial direct current stimulationThis instrument will be used to induce post-stroke motor recovery, two different monocephalic montages are typically used to restore excitability in the lesioned hemisphere and to down-regulate excitability of the non-lesioned hemisphere and rebalance Interhemispheric inhibition. each participant will undergo a 20-minute period of tDCS, applied at 2 mA through a pair of saline-soaked surface sponge electrodes (35 cm2). | Device | Dual-tDCS & PT, Sham-tDCS & PT |
Primary outcome
Change from baseline gait speed at post-intervention
Time frame: immediately post-intervention
Force distribution measurement (FDM; The WinFDM and platform, Zebris Medical GmbH, Germany) will be used to analyze step length in centimeters (cm). Participants will walk 3 meters per trial on a platform and be assessed 5 times. The result will be selected from an average of five trials. Participants can rest between trials for about 2 minutes or as long as they desired to avoid fatigue.
Change from baseline gait speed at 1 week post-intervention
Time frame: 1 week post-intervention
Force distribution measurement (FDM; The WinFDM and platform, Zebris Medical GmbH, Germany) will be used to analyze step length in centimeters (cm). Participants will walk 3 meters per trial on a platform and be assessed 5 times. The result will be selected from an average of five trials. Participants can rest between trials for about 2 minutes or as long as they desired to avoid fatigue.
Change from baseline gait speed at 1 month post-intervention
Time frame: 1 month post-intervention
Force distribution measurement (FDM; The WinFDM and platform, Zebris Medical GmbH, Germany) will be used to analyze step length in centimeters (cm). Participants will walk 3 meters per trial on a platform and be assessed 5 times. The result will be selected from an average of five trials. Participants can rest between trials for about 2 minutes or as long as they desired to avoid fatigue.
Change from baseline gait speed at 2 month post-intervention
Time frame: 2 month post-intervention
Force distribution measurement (FDM; The WinFDM and platform, Zebris Medical GmbH, Germany) will be used to analyze step length in centimeters (cm). Participants will walk 3 meters per trial on a platform and be assessed 5 times. The result will be selected from an average of five trials. Participants can rest between trials for about 2 minutes or as long as they desired to avoid fatigue.
Change from baseline gait speed at 3 month post-intervention
Time frame: 3 month post-intervention
Force distribution measurement (FDM; The WinFDM and platform, Zebris Medical GmbH, Germany) will be used to analyze step length in centimeters (cm). Participants will walk 3 meters per trial on a platform and be assessed 5 times. The result will be selected from an average of five trials. Participants can rest between trials for about 2 minutes or as long as they desired to avoid fatigue.
30 secondary outcomes
Change from baseline spatiotemporal gait variable at post-intervention
Time frame: immediately post-intervention
Change from baseline spatiotemporal gait variable at 1 week
Time frame: 1 week post-intervention
Change from baseline spatiotemporal gait variable at 1 month
Time frame: 1 month post-intervention
Change from baseline spatiotemporal gait variable at 2 months
Time frame: 2 months post-intervention
Change from baseline spatiotemporal gait variable at 3 months
Time frame: 3 months post-intervention
Change from baseline muscle strength at post-intervention
Time frame: immediately post-intervention
Change from baseline muscle strength at 1 week
Time frame: 1 week post-intervention
Change from baseline muscle strength at 1 month
Time frame: 1 month post-intervention
Change from baseline muscle strength at 2 months
Time frame: 2 months post-intervention
Change from baseline muscle strength at 3 months
Time frame: 3 months post-intervention
Change from baseline FMA-LE at post-intervention
Time frame: immediately post-intervention
Change from baseline FMA-LE at 1 week
Time frame: 1 week post-intervention
Change from baseline FMA-LE at 1 month
Time frame: 1 month post-intervention
Change from baseline FMA-LE at 2 months
Time frame: 2 months post-intervention
Change from baseline FMA-LE at 3 months
Time frame: 3 months post-intervention
Change from baseline Stroke Impact Scale at post-intervention
Time frame: immediately post-intervention
Change from baseline Stroke Impact Scale at 1 week
Time frame: 1 week post-intervention
Change from baseline Stroke Impact Scale at 1 month
Time frame: 1 month post-intervention
Change from baseline Stroke Impact Scale at 2 months
Time frame: 2 months post-intervention
Change from baseline Stroke Impact Scale at 3 months
Time frame: 3 months post-intervention
Change from baseline Timed-up and go test (TUG) at post-intervention
Time frame: immediately post-intervention
Change from baseline Timed-up and go test (TUG) at 1 week
Time frame: 1 week post-intervention
Change from baseline Timed-up and go test (TUG) at 1 month
Time frame: 1 month post-intervention
Change from baseline Timed-up and go test (TUG) at 2 months
Time frame: 2 months post-intervention
Change from baseline Timed-up and go test (TUG) at 3 months
Time frame: 3 months post-intervention
Change from baseline Five Times Sit to Stand Test (FTSTS) at post-intervention
Time frame: immediately post-intervention
Change from baseline Five Times Sit to Stand Test (FTSTS) at 1 week
Time frame: 1 week post-intervention
Change from baseline Five Times Sit to Stand Test (FTSTS) at 1 month
Time frame: 1 month post-intervention
Change from baseline Five Times Sit to Stand Test (FTSTS) at 2 months
Time frame: 2 months post-intervention
Change from baseline Five Times Sit to Stand Test (FTSTS) at 3 months
Time frame: 3 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wanalee Klomjai, PhD study director
MU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation in people with Stroke, Ischemic, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline gait speed at post-intervention (time frame: immediately post-intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.