StrokeNCT06838013
Effect of Combining Central and Peripheral Cutaneous Electrical Stimulation on Lower Limb Motor Function in People With Stroke
A study testing Transcranial direct current stimulation (tDCS), Bilateral Transcutaneous electrical nerve stimulation (Bi-TENS) and Lower-limb task-oriented training in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
This study aims to evaluate the effectiveness of transcranial direct current stimulation (tDCS) and transcutaneous electrical nerve stimulation (TENS) in augmenting the efficacy of the lower limb task-oriented training in people with stroke. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Transcranial direct current stimulation (tDCS), Bilateral Transcutaneous electrical nerve stimulation (Bi-TENS) and Lower-limb task-oriented training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Mar 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- are between 50 and 85 years of age;
- have had a single stroke more than 6 months and less than 15 years;
- have at least 5 degrees of active ankle dorsiflexion in the antigravity position;
- are able to walk 10 m independently, with or without a walking aid;
- are able to score 6 or higher out of 10 on the abbreviated mental test;
- have no skin allergies (e.g. redness or itchiness after application of the electrical stimulation pads) to electrical stimulation or electrodes;
- are able to follow instructions and give informed consent.
Who cannot join
- have any additional medical, cardiovascular or orthopedic conditions that would hinder their treatment or assessment;
- have a cardiac pacemaker;
- have aphasia or cognitive difficulties that may interfere with their comprehension of instructions;
- have had one or more epileptic seizures within the year prior to the date of inclusion in the study;
- have an intracerebral metal clip;
- have a major somatosensory deficit
- have any contraindication to tDCS;
- are currently involved in drug studies or other clinical trials.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Hong Kong
Shamay Ng, PhD, +852 27664889, shamay.ng@polyu.edu.hk
Shamay Ng, PhD
About this study
Official title: A Randomized Controlled Trial of Anodal Transcranial Direct Current Stimulation and Transcutaneous Electrical Nerve Stimulation for Improving Lower Limb Function in Stroke Patients
This study aims to evaluate the effectiveness of transcranial direct current stimulation (tDCS) and transcutaneous electrical nerve stimulation (TENS) in augmenting the efficacy of the lower limb task-oriented training in people with stroke. It is hypothesize that lower limb motor function can be best improved by combining anodal tDCS with TENS, when compared with sham-tDCS with TENS, anodal tDCS with placebo-TENS, or control training at improving ankle muscle strength, motor control of lower limbs, walking performance, functional mobility and community integration in people with stroke.
Read the detailed description
The application of transcutaneous electrical nerve stimulation (TENS) over a paretic lower limb could augment the effects of task-oriented exercise therapy on lower limb motor function in people with stroke, possibly through increased excitability of sensorimotor cortex.
In transcranial direct current stimulation (tDCS), a weak electrical current is applied through electrodes placed on the scalp to modulate cortical excitability and neural activity in targeted brain regions. Anodal tDCS, specifically, involves positioning the positively charged electrode over the targeted cortical area, which facilitates neuronal depolarization and increases cortical excitability in the underlying brain tissue. The enhanced neural excitability induced by anodal tDCS could promote neuroplasticity and optimize motor learning processes, potentially through the modulation of N-methyl-D-aspartic acid (NMDA) receptor -dependent mechanisms and alterations in GABAergic activity, leading to improved motor function and rehabilitation outcomes in various neurological conditions.
The next question concerns whether anodal tDCS could be combined with TENS and whether their synergetic effects could maximise the motor output of paretic limbs in people with stroke.
- Conditions
- Stroke
- Being tested
- Transcranial direct current stimulation (tDCS), Sham transcranial direct current stimulation (Sham-tDCS), Bilateral Transcutaneous electrical nerve stimulation (Bi-TENS), Placebo transcutaneous electrical nerve stimulation (Placebo-TENS), Lower-limb task-oriented training
- Keywords
- transcranial direct current stimulation, transcutaneous electric nerve stimulation, stroke, rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulation (tDCS)Device
tDCS will be delivered by a constant-current electrical stimulator (DC-stimulator; Eldith, Ilmenau, Germany). Rectangular electrodes covered with a saline-soaked sponge will be used for the anode and cathode. The anode will be placed over the leg area of the motor cortex, on the lesioned side, with the medial border of the electrode placed laterally to Cz on the international electroencephalogram 10-20 system. The cathode will be placed above the contralateral orbit. The stimulation intensity will be set at 2 mA for 30 minutes.
Sham transcranial direct current stimulation (Sham-tDCS)Device
Sham tDCS will be delivered by a constant-current electrical stimulator (DC-stimulator; Eldith, Ilmenau, Germany). Rectangular electrodes covered with a saline-soaked sponge will be used for the anode and cathode. The anode will be placed over the leg area of the motor cortex, on the lesioned side, with the medial border of the electrode placed laterally to Cz on the international electroencephalogram 10-20 system. The cathode will be placed above the contralateral orbit. The stimulation intensity will The stimulator will only be applied for the first and last 30 seconds.
Bilateral Transcutaneous electrical nerve stimulation (Bi-TENS)Device
TENS will be delivered to the common peroneal nerve of both intact and paretic leg for 30 minutes using a 120z Dual-Channel TENS Unit (ITO Physiotherapy \& Rehabilittaion, Co, Ltd, Tokyo, Japan). The TENS stimulation will be at 100 Hz, with 0.2 ms square pulses at an intensity of twice the sensory threshold (defined as the minimum intensity at which subject reported feeling a tingling sensation and below the motor threshold as indicated by the absence of muscle twitching.
Placebo transcutaneous electrical nerve stimulation (Placebo-TENS)Device
Placebo-TENS will be applied to identical-looking TENS devices, with the electrical circuit disconnected inside the devices. Placebo-TENS will be delivered to the common peroneal nerve of both intact and paretic leg for 30 minutes that set at 100 Hz, with 0.2 ms square pulses.
Lower-limb task-oriented trainingBehavioural
The lower-limb task-oriented training comprises 5 exercises for 30 minutes, namely stepping up and down, heel lift a dorsiflexed position, partial squatting, gait re-education and transition training.
| Study group | Role | What they receive |
|---|---|---|
| Anodal tDCS+Bi-TENS | Experimental | All subjects will receive eighteen 60-minute sessions of intervention, 3 sessions per week for 6 weeks. Receives: Device: Transcranial direct current stimulation (tDCS); Device: Bilateral Transcutaneous electrical nerve stimulation (Bi-TENS); Behavioral: Lower-limb task-oriented training |
| Sham-tDCS+Bi-TENS | Sham comparator | All subjects will receive eighteen 60-minute sessions of intervention, 3 sessions per week for 6 weeks. Receives: Device: Sham transcranial direct current stimulation (Sham-tDCS); Device: Bilateral Transcutaneous electrical nerve stimulation (Bi-TENS); Behavioral: Lower-limb task-oriented training |
| Anodal tDCS+placebo-TENS | Placebo comparator | All subjects will receive eighteen 60-minute sessions of intervention, 3 sessions per week for 6 weeks. |
| Control training | Placebo comparator | All subjects will receive eighteen 60-minute sessions of intervention, 3 sessions per week for 6 weeks. Receives: Device: Sham transcranial direct current stimulation (Sham-tDCS); Device: Placebo transcutaneous electrical nerve stimulation (Placebo-TENS); Behavioral: Lower-limb task-oriented training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Paretic ankle dorsiflexor strength
The paretic ankle dorsiflexor strength (in kilograms) is measured with a Nicholas hand-held dynamometer (model 01,160, Lafayette Instrument Company, Lafayette, IN) in supine lying position. The muscle strength will be measured twice. The average strength of the 2 trials will be recorded. A higher value indicated a better paretic ankle dorsiflexor strength.
Measured: Baseline (0 week), Mid-intervention (3 weeks), Post-intervention (6 weeks), 1-month follow-up (10 weeks)
Paretic ankle plantarflexor strength
The paretic ankle plantarflexor strength (in kilograms) is measured with a Nicholas hand-held dynamometer (model 01,160, Lafayette Instrument Company, Lafayette, IN) in supine lying position. The muscle strength will be measured twice. The average strength of the 2 trials will be recorded. A higher value indicated a better paretic ankle dorsiflexor strength.
Measured: Baseline (0 week), Mid-intervention (3 weeks), Post-intervention (6 weeks), 1-month follow-up (10 weeks)
Fugl-Meyer Assessment of Lower Extremity (FMA-LE)
FMA-LE is used to evaluate the lower extremity motor control, including reflexes, voluntary control of isolated movement and coordination. The scale score ranging from 0 to 34, with 17 items and ordinal scoring from 0 to 2. A higher score indicates a better lower extremity motor control.
Measured: Baseline (0 week), Mid-intervention (3 weeks), Post-intervention (6 weeks), 1-month follow-up (10 weeks)
Secondary outcomes (10)
10-Meter Walk Test (10MWT)
The subject will be asked to walk 10 meter in a comfortable speed. The completion time will be records by stopwatch. The test will be repeated for 2 times. The completion time will be averaged. The shorter the completion time, the better performance is.
Measured: Baseline (0 week), Mid-intervention (3 weeks), Post-intervention (6 weeks), 1-month follow-up (10 weeks)
Timed 'Up and Go' test (TUG)
The TUG is used to measure the functional mobility. Each subject will be required to rise from a chair with armrests, walk 3 m forward, turn around, return to the chair and sit down. The time taken to complete this task will be measured in seconds with a stopwatch. Each condition will be repeated for 2 times. The completion time will be averaged.
Measured: Baseline (0 week), Mid-intervention (3 weeks), Post-intervention (6 weeks), 1-month follow-up (10 weeks)
Lower-extremity motor co-ordination test
The lower-extremity motor coordination test is used to measure the coordination of both the paretic and intact legs. Two red flat targets will be secured on the floor 30 cm apart. In sitting position with the feet resting flat on the floor and the heels on one of the targets, the participant will be instructed to touch 2 targets alternately with the big toe, as quickly and as accurately as possible, for 20 seconds. The number of times each target is touched will be counted. The more touch times indicated a better performance.
Measured: Baseline (0 week), Mid-intervention (3 weeks), Post-intervention (6 weeks), 1-month follow-up (10 weeks)
Gait Parameters (via GAITRite)
Gait parameters will be assessed using the GAITRite system (CIR system, Inc., Havertown, Pennsylvania), a pressure-sensitive mat that automatically captures spatiotemporal gait characteristics. Participants will walk at their self-selected comfortable pace along the instrumented walkway.
Measured: Baseline (0 week), Mid-intervention (3 weeks), Post-intervention (6 weeks), 1-month follow-up (10 weeks)
Berg Balance Scale (BBS)
BBS is a 14-item objective measure that assesses static balance and fall risk in adult patients. Items include tasks such as sitting to standing, standing unsupported, transfers, reaching, turning 360 degrees, and single-leg stance. Each item is scored from 0-4 points (0=unable to perform, 4=independent), with a maximum total score of 56 points. Higher scores indicate better balance.
Measured: Baseline (0 week), Mid-intervention (3 weeks), Post-intervention (6 weeks), 1-month follow-up (10 weeks)
Limits of Stability (LOS) Test
The Limits of Stability (LOS) test quantifies participants' ability to intentionally shift their center of gravity (COG) to their stability limits without losing balance using Bertec Balance Advantage System (Bertec Corporation, Columbus, OH, USA). Participants stand on a force plate and shift their weight to move a cursor on a screen toward 8 targets arranged in a circular pattern at their theoretical limits of stability (100% LOS). Key parameters measured reaction time (RT) , movement velocity (MVL), directional control (DCL), endpoint excursion (EPE), maximum excursion (MXE). Higher scores indicate better dynamic balance control, except for reaction time where lower scores are better.
Measured: Baseline (0 week), Mid-intervention (3 weeks), Post-intervention (6 weeks), 1-month follow-up (10 weeks)
Sensory Organization Test (SOT)
SOT assesses the participant's ability to maintain postural stability by evaluating the integration of visual, vestibular, and somatosensory inputs using Bertec Balance Advantage System (Bertec Corporation, Columbus, OH, USA). The test systematically disrupts sensory information while measuring postural sway.
Outcome measures include composite equilibrium score and sensory analysis ratios (somatosensory, visual, vestibular, and preference ratios). Higher scores indicate better postural stability and sensory integration.
Measured: Baseline (0 week), Mid-intervention (3 weeks), Post-intervention (6 weeks), 1-month follow-up (10 weeks)
Cantonese version of Community Integration Measures (CIM-C)
The level of community integration will be assessed by the Cantonese version of Community Integration Measures (CIM-C). The CIM is a client-centred questionnaire with 10 items; each item rating from 1 to 5 with a total score from 10 to 50. A higher CIM-C score indicates a higher level of community integration.
Measured: Baseline (0 week), Mid-intervention (3 weeks), Post-intervention (6 weeks), 1-month follow-up (10 weeks)
Foot & Ankle Disability Index Score (FADI)
FADI is a 26-item patient-reported outcome measure that assesses functional limitations related to foot and ankle conditions. The questionnaire consists of 22 items assessing activities of daily living and 4 items specific to pain. Each item is scored on a 5-point Likert scale from 0 (unable to do) to 4 (no difficulty at all). Total scores are converted to percentages, with 100% representing no dysfunction. The FADI includes activities such as walking on even/uneven ground, climbing stairs, squatting, and recreational activities.
Measured: Baseline (0 week), Mid-intervention (3 weeks), Post-intervention (6 weeks), 1-month follow-up (10 weeks)
EQ-5D Visual Analogue Scale (EQ-5D VAS)
The EQ-5D VAS is a standardized vertical visual analog scale (thermometer-like scale) that measures self-rated health status. Participants rate their overall health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state). This scale is part of the EQ-5D instrument but specifically captures the respondent's overall self-rated health status on the day of assessment. The VAS provides a quantitative measure of health outcome that reflects the participant's own judgment.
Measured: Baseline (0 week), Mid-intervention (3 weeks), Post-intervention (6 weeks), 1-month follow-up (10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start1 Mar 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shamay Ng, The Hong Kong Polytechnic University
- Investigators
- Shamay Ng, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838013
- Sponsor's protocol ID
- 2023_GRF_Ng
- Status last verified
- Sep 2026
- First submitted
- 16 Feb 2025
- Last updated
- 29 Sep 2026
- 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 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Anodal Transcranial Direct Current Stimulation and Transcutaneous Electrical Nerve Stimulation for Improving Lower Limb Function in Stroke Patients
- ClinicalTrials.gov ID
- NCT06838013
- Acronym / sponsor ID
- 2023_GRF_Ng
- Conditions
- Stroke
- Keywords
- transcranial direct current stimulation, transcutaneous electric nerve stimulation, stroke, rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 20 Feb 2025 (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.
This study aims to evaluate the effectiveness of transcranial direct current stimulation (tDCS) and transcutaneous electrical nerve stimulation (TENS) in augmenting the efficacy of the lower limb task-oriented training in people with stroke. It is hypothesize that lower limb motor function can be best improved by combining anodal tDCS with TENS, when compared with sham-tDCS with TENS, anodal tDCS with placebo-TENS, or control training at improving ankle muscle strength, motor control of lower limbs, walking performance, functional mobility and community integration in people with stroke.
Detailed description
The application of transcutaneous electrical nerve stimulation (TENS) over a paretic lower limb could augment the effects of task-oriented exercise therapy on lower limb motor function in people with stroke, possibly through increased excitability of sensorimotor cortex.
In transcranial direct current stimulation (tDCS), a weak electrical current is applied through electrodes placed on the scalp to modulate cortical excitability and neural activity in targeted brain regions. Anodal tDCS, specifically, involves positioning the positively charged electrode over the targeted cortical area, which facilitates neuronal depolarization and increases cortical excitability in the underlying brain tissue. The enhanced neural excitability induced by anodal tDCS could promote neuroplasticity and optimize motor learning processes, potentially through the modulation of N-methyl-D-aspartic acid (NMDA) receptor -dependent mechanisms and alterations in GABAergic activity, leading to improved motor function and rehabilitation outcomes in various neurological conditions.
The next question concerns whether anodal tDCS could be combined with TENS and whether their synergetic effects could maximise the motor output of paretic limbs in people with stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS+Bi-TENS | Experimental | Device: Transcranial direct current stimulation (tDCS), Device: Bilateral Transcutaneous electrical nerve stimulation (Bi-TENS), Behavioral: Lower-limb task-oriented trainingAll subjects will receive eighteen 60-minute sessions of intervention, 3 sessions per week for 6 weeks. |
| Sham-tDCS+Bi-TENS | Sham comparator | Device: Sham transcranial direct current stimulation (Sham-tDCS), Device: Bilateral Transcutaneous electrical nerve stimulation (Bi-TENS), Behavioral: Lower-limb task-oriented trainingAll subjects will receive eighteen 60-minute sessions of intervention, 3 sessions per week for 6 weeks. |
| Anodal tDCS+placebo-TENS | Placebo comparator | –All subjects will receive eighteen 60-minute sessions of intervention, 3 sessions per week for 6 weeks. |
| Control training | Placebo comparator | Device: Sham transcranial direct current stimulation (Sham-tDCS), Device: Placebo transcutaneous electrical nerve stimulation (Placebo-TENS), Behavioral: Lower-limb task-oriented trainingAll subjects will receive eighteen 60-minute sessions of intervention, 3 sessions per week for 6 weeks. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- are between 50 and 85 years of age;
- have had a single stroke more than 6 months and less than 15 years;
- have at least 5 degrees of active ankle dorsiflexion in the antigravity position;
- are able to walk 10 m independently, with or without a walking aid;
- are able to score 6 or higher out of 10 on the abbreviated mental test;
Key exclusion criteria (8 listed)
- have any additional medical, cardiovascular or orthopedic conditions that would hinder their treatment or assessment;
- have a cardiac pacemaker;
- have aphasia or cognitive difficulties that may interfere with their comprehension of instructions;
- have had one or more epileptic seizures within the year prior to the date of inclusion in the study;
- have an intracerebral metal clip;
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 stimulation (tDCS)tDCS will be delivered by a constant-current electrical stimulator (DC-stimulator; Eldith, Ilmenau, Germany). Rectangular electrodes covered with a saline-soaked sponge will be used for the anode and cathode. The anode will be placed over the leg area of the motor cortex, on the lesioned side, with the medial border of the electrode placed laterally to Cz on the international electroencephalogram 10-20 system. The cathode will be placed above the contralateral orbit. The stimulation intensity will be set at 2 mA for 30 minutes. | Device | Anodal tDCS+Bi-TENS |
| Sham transcranial direct current stimulation (Sham-tDCS)Sham tDCS will be delivered by a constant-current electrical stimulator (DC-stimulator; Eldith, Ilmenau, Germany). Rectangular electrodes covered with a saline-soaked sponge will be used for the anode and cathode. The anode will be placed over the leg area of the motor cortex, on the lesioned side, with the medial border of the electrode placed laterally to Cz on the international electroencephalogram 10-20 system. The cathode will be placed above the contralateral orbit. The stimulation intensity will The stimulator will only be applied for the first and last 30 seconds. | Device | Control training, Sham-tDCS+Bi-TENS |
| Bilateral Transcutaneous electrical nerve stimulation (Bi-TENS)TENS will be delivered to the common peroneal nerve of both intact and paretic leg for 30 minutes using a 120z Dual-Channel TENS Unit (ITO Physiotherapy \& Rehabilittaion, Co, Ltd, Tokyo, Japan). The TENS stimulation will be at 100 Hz, with 0.2 ms square pulses at an intensity of twice the sensory threshold (defined as the minimum intensity at which subject reported feeling a tingling sensation and below the motor threshold as indicated by the absence of muscle twitching. | Device | Anodal tDCS+Bi-TENS, Sham-tDCS+Bi-TENS |
| Placebo transcutaneous electrical nerve stimulation (Placebo-TENS)Placebo-TENS will be applied to identical-looking TENS devices, with the electrical circuit disconnected inside the devices. Placebo-TENS will be delivered to the common peroneal nerve of both intact and paretic leg for 30 minutes that set at 100 Hz, with 0.2 ms square pulses. | Device | Control training |
| Lower-limb task-oriented trainingThe lower-limb task-oriented training comprises 5 exercises for 30 minutes, namely stepping up and down, heel lift a dorsiflexed position, partial squatting, gait re-education and transition training. | Behavioural | Anodal tDCS+Bi-TENS, Control training, Sham-tDCS+Bi-TENS |
Primary outcome
Paretic ankle dorsiflexor strength
Time frame: Baseline (0 week), Mid-intervention (3 weeks), Post-intervention (6 weeks), 1-month follow-up (10 weeks)
The paretic ankle dorsiflexor strength (in kilograms) is measured with a Nicholas hand-held dynamometer (model 01,160, Lafayette Instrument Company, Lafayette, IN) in supine lying position. The muscle strength will be measured twice. The average strength of the 2 trials will be recorded. A higher value indicated a better paretic ankle dorsiflexor strength.
Paretic ankle plantarflexor strength
Time frame: Baseline (0 week), Mid-intervention (3 weeks), Post-intervention (6 weeks), 1-month follow-up (10 weeks)
The paretic ankle plantarflexor strength (in kilograms) is measured with a Nicholas hand-held dynamometer (model 01,160, Lafayette Instrument Company, Lafayette, IN) in supine lying position. The muscle strength will be measured twice. The average strength of the 2 trials will be recorded. A higher value indicated a better paretic ankle dorsiflexor strength.
Fugl-Meyer Assessment of Lower Extremity (FMA-LE)
Time frame: Baseline (0 week), Mid-intervention (3 weeks), Post-intervention (6 weeks), 1-month follow-up (10 weeks)
FMA-LE is used to evaluate the lower extremity motor control, including reflexes, voluntary control of isolated movement and coordination. The scale score ranging from 0 to 34, with 17 items and ordinal scoring from 0 to 2. A higher score indicates a better lower extremity motor control.
10 secondary outcomes
10-Meter Walk Test (10MWT)
Time frame: Baseline (0 week), Mid-intervention (3 weeks), Post-intervention (6 weeks), 1-month follow-up (10 weeks)
Timed 'Up and Go' test (TUG)
Time frame: Baseline (0 week), Mid-intervention (3 weeks), Post-intervention (6 weeks), 1-month follow-up (10 weeks)
Lower-extremity motor co-ordination test
Time frame: Baseline (0 week), Mid-intervention (3 weeks), Post-intervention (6 weeks), 1-month follow-up (10 weeks)
Gait Parameters (via GAITRite)
Time frame: Baseline (0 week), Mid-intervention (3 weeks), Post-intervention (6 weeks), 1-month follow-up (10 weeks)
Berg Balance Scale (BBS)
Time frame: Baseline (0 week), Mid-intervention (3 weeks), Post-intervention (6 weeks), 1-month follow-up (10 weeks)
Limits of Stability (LOS) Test
Time frame: Baseline (0 week), Mid-intervention (3 weeks), Post-intervention (6 weeks), 1-month follow-up (10 weeks)
Sensory Organization Test (SOT)
Time frame: Baseline (0 week), Mid-intervention (3 weeks), Post-intervention (6 weeks), 1-month follow-up (10 weeks)
Cantonese version of Community Integration Measures (CIM-C)
Time frame: Baseline (0 week), Mid-intervention (3 weeks), Post-intervention (6 weeks), 1-month follow-up (10 weeks)
Foot & Ankle Disability Index Score (FADI)
Time frame: Baseline (0 week), Mid-intervention (3 weeks), Post-intervention (6 weeks), 1-month follow-up (10 weeks)
EQ-5D Visual Analogue Scale (EQ-5D VAS)
Time frame: Baseline (0 week), Mid-intervention (3 weeks), Post-intervention (6 weeks), 1-month follow-up (10 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- 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.
Shamay Ng, PhD principal investigator
The Hong Kong Polytechnic University
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 (tDCS), Bilateral Transcutaneous electrical nerve stimulation (Bi-TENS) and Lower-limb task-oriented training in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 29 Sep 2026. 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 Hong Kong. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shamay NG, PhD (+852 27664889, shamay.ng@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paretic ankle dorsiflexor strength (time frame: Baseline (0 week), Mid-intervention (3 weeks), Post-intervention (6 weeks), 1-month follow-up (10 weeks)). The study lists 3 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 29 Sep 2026.