StrokeNCT03622879
Mirror Therapy With Cutaneous Electrical Sensory Stimulation on Lower Limb Motor Functions in Stroke
A study testing MT, 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 concurrent mirror therapy (MT) 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 55 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- MT, 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
- 100 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 Jul 2018to 1 Jun 2026
- 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 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have had a single stroke with ischemic brain injury or intracerebral haemorrhage diagnosed by magnetic resonance imaging or computed tomography within the previous 6 to 36 months;
- 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 unilateral neglect, hemianopia or apraxia;
- have no skin allergy (e.g. redness or itchiness to the electrical stimulation pads) to electrical stimulation or electrodes; and
- are able to follow instructions and give informed consent.
Who cannot join
- have any additional medical, cardiovascular or orthopaedic condition that would hinder proper treatment or assessment;
- have visual deficits that may hinder them from benefiting from the mirror visual feedback;
- have receptive dysphasia; or
- are involved in drug studies or other clinical trials.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Mirror Therapy With Cutaneous Electrical Sensory Stimulation on Lower Limb Motor Functions in People With Stroke: A Single-blinded Randomized Controlled Trial
This study aims to evaluate the effectiveness of concurrent mirror therapy (MT) 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 MT combined with TENS would be superior to sham-mirror therapy with TENS, or MT with placebo-TENS, or control training only in improving lower limb motor functions and walking ability in people with stroke when combined with the lower limb task-oriented training.
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 mirror therapy (MT), the intact limb performs motor tasks while its mirror reflection is superimposed over the covered paretic limb, creating a visual illusion of enhanced function over the paretic limb. The visual input during MT could substitute for reduced proprioceptive inputs and increase spatial attention of the paretic limb, which could improve motor function of the paretic limb, possibly through increased cortical activity in the lesioned hemisphere and mirror neurone system.
The next question concerns whether MT 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
- MT, TENS, Lower-limb task-oriented training
- Keywords
- Mirror therapy, Transcutaneous Electric Nerve Stimulation, Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTBehavioural
A customised angle-adjustable frame with a mirror board (60 × 90 cm) will be used. All subjects are instructed to perform hip flexion/abduction, knee flexion/extension and ankle dorsiflexion/plantarflexion on the intact-limb during a 15 minutes period.
TENSDevice
TENS will be delivered to the common peroneal nerve of the paretic leg. The stimulation frequency will be 100Hz and with an intensity just below the motor threshold.
Lower-limb task-oriented trainingBehavioural
The lower-limb task-oriented training comprises 6 exercises, namely stepping up and down, heel lift a dorsiflexed position, partial squatting, kicking a ball with alternate legs, gait re-education and transition training. Each exercise last for 10 minutes
| Study group | Role | What they receive |
|---|---|---|
| MT + TENS | Experimental | The subject will adopt a semi-seated position on a bed while the mirror board is positioned between the legs perpendicular to the subject's midline. The paretic leg will be positioned behind the mirror, with the intact leg facing the reflective surface. All subjects will be reminded to focus on the image in the mirror during MT training. All subjects will receive concurrent TENS stimulation over the common peroneal nerve while practising bilateral lower limb exercises. After 15 minutes of priming with TENS + MT, all subjects will perform 60 minutes of lower limb task-oriented training. Receives: Behavioral: MT; Device: TENS; Behavioral: Lower-limb task-oriented training |
| Placebo-MT+TENS | Placebo comparator | In the Placebo-MT+TENS group, the experimental set-up and protocol will be the same as in the MT+TENS group, except that the reflecting surface of the angle-adjustable mirror was covered with paper. After 15 minutes of priming, all subjects will perform 60 minutes of lower limb task-oriented training. Receives: Device: TENS; Behavioral: Lower-limb task-oriented training |
| MT+placebo-TENS | Placebo comparator | In the MT+placebo-TENS group, the experimental set-up and protocol will be the same as in the MT+TENS group. The only difference is that placebo stimulation will be applied to the paretic limb from identical-looking TENS devices with the electrical circuit disconnected inside. After 15 minutes of priming, all subjects will perform 60 minutes of lower limb task-oriented training. Receives: Behavioral: MT; Behavioral: Lower-limb task-oriented training |
| control training | Sham comparator | All subjects will perform 60 minutes of lower limb task-oriented training only. Receives: Behavioral: Lower-limb task-oriented training |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change of 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. The assessment will be conducted at baseline, mid-intervention (4 weeks), post-intervention (8 weeks) and 3-month follow-up (20 weeks).
Measured: Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)
Secondary outcomes (6)
The Change of Paretic ankle dorsiflexor strength
The subject's 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. The assessment will be conducted at baseline, mid-intervention (4 weeks), post-intervention (8 weeks) and 3-month follow-up (20 weeks).
Measured: Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)
The Change of Paretic ankle plantarflexor strength
The subject's 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 average strength of the 2 trials will be recorded. A higher value indicated a better paretic ankle plantarflexor strength. The assessment will be conducted at baseline, mid-intervention (4 weeks), post-intervention (8 weeks) and 3-month follow-up (20 weeks).
Measured: Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)
The Change of 10-m walk test
10-m walk test is used to measure the walking speed in a short distance. The subject will be asked to walk 10 meter in a normal comfortable speed and maximum speed condition, respectively. The completion time will be records by stopwatch. Each condition will be repeated for 2 times. The completion time will be averaged. The shorter the completion time indicated the better performance in 10-m walk test. The assessment will be conducted at baseline, mid-intervention (4 weeks), post-intervention (8 weeks) and 3-month follow-up (20 weeks).
Measured: Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)
The Change of Timed 'Up and Go' test
The Time 'Up and Go' test 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. The assessment will be conducted at baseline, mid-intervention (4 weeks), post-intervention (8 weeks) and 3-month follow-up (20 weeks).
Measured: Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)
The Change of 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. The assessment will be conducted at baseline, mid-intervention (4 weeks), post-intervention (8 weeks) and 3-month follow-up (20 weeks).
Measured: Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)
The Change of 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. The assessment will be conducted at baseline, mid-intervention (4 weeks), post-intervention (8 weeks) and 3-month follow-up (20 weeks).
Measured: Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start2 Jul 2018
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
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.
- 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
- 100 participants (actual)
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
- SSM Ng, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622879
- Sponsor's protocol ID
- 2018_GRF_NG
- Status last verified
- Oct 2026
- First submitted
- 10 Jul 2018
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mirror Therapy With Cutaneous Electrical Sensory Stimulation on Lower Limb Motor Functions in People With Stroke: A Single-blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03622879
- Acronym / sponsor ID
- 2018_GRF_NG
- Conditions
- Stroke
- Keywords
- Mirror therapy, Transcutaneous Electric Nerve Stimulation, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 9 Aug 2018 (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 concurrent mirror therapy (MT) 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 MT combined with TENS would be superior to sham-mirror therapy with TENS, or MT with placebo-TENS, or control training only in improving lower limb motor functions and walking ability in people with stroke when combined with the lower limb task-oriented training.
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 mirror therapy (MT), the intact limb performs motor tasks while its mirror reflection is superimposed over the covered paretic limb, creating a visual illusion of enhanced function over the paretic limb. The visual input during MT could substitute for reduced proprioceptive inputs and increase spatial attention of the paretic limb, which could improve motor function of the paretic limb, possibly through increased cortical activity in the lesioned hemisphere and mirror neurone system.
The next question concerns whether MT 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 |
|---|---|---|
| MT + TENS | Experimental | Behavioral: MT, Device: TENS, Behavioral: Lower-limb task-oriented trainingThe subject will adopt a semi-seated position on a bed while the mirror board is positioned between the legs perpendicular to the subject's midline. The paretic leg will be positioned behind the mirror, with the intact leg facing the reflective surface. All subjects will be reminded to focus on the image in the mirror during MT training. All subjects will receive concurrent TENS stimulation over the common peroneal nerve while practising bilateral lower limb exercises. After 15 minutes of priming with TENS + MT, all subjects will perform 60 minutes of lower limb task-oriented training. |
| Placebo-MT+TENS | Placebo comparator | Device: TENS, Behavioral: Lower-limb task-oriented trainingIn the Placebo-MT+TENS group, the experimental set-up and protocol will be the same as in the MT+TENS group, except that the reflecting surface of the angle-adjustable mirror was covered with paper. After 15 minutes of priming, all subjects will perform 60 minutes of lower limb task-oriented training. |
| MT+placebo-TENS | Placebo comparator | Behavioral: MT, Behavioral: Lower-limb task-oriented trainingIn the MT+placebo-TENS group, the experimental set-up and protocol will be the same as in the MT+TENS group. The only difference is that placebo stimulation will be applied to the paretic limb from identical-looking TENS devices with the electrical circuit disconnected inside. After 15 minutes of priming, all subjects will perform 60 minutes of lower limb task-oriented training. |
| control training | Sham comparator | Behavioral: Lower-limb task-oriented trainingAll subjects will perform 60 minutes of lower limb task-oriented training only. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- have had a single stroke with ischemic brain injury or intracerebral haemorrhage diagnosed by magnetic resonance imaging or computed tomography within the previous 6 to 36 months;
- 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 unilateral neglect, hemianopia or apraxia;
Key exclusion criteria (4 listed)
- have any additional medical, cardiovascular or orthopaedic condition that would hinder proper treatment or assessment;
- have visual deficits that may hinder them from benefiting from the mirror visual feedback;
- have receptive dysphasia; or
- are involved in drug studies or other clinical trials.
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 |
|---|---|---|
| MTA customised angle-adjustable frame with a mirror board (60 × 90 cm) will be used. All subjects are instructed to perform hip flexion/abduction, knee flexion/extension and ankle dorsiflexion/plantarflexion on the intact-limb during a 15 minutes period. | Behavioural | MT + TENS, MT+placebo-TENS |
| TENSTENS will be delivered to the common peroneal nerve of the paretic leg. The stimulation frequency will be 100Hz and with an intensity just below the motor threshold. | Device | MT + TENS, Placebo-MT+TENS |
| Lower-limb task-oriented trainingThe lower-limb task-oriented training comprises 6 exercises, namely stepping up and down, heel lift a dorsiflexed position, partial squatting, kicking a ball with alternate legs, gait re-education and transition training. Each exercise last for 10 minutes | Behavioural | MT + TENS, MT+placebo-TENS, Placebo-MT+TENS, control training |
Primary outcome
The Change of Fugl-Meyer Assessment of Lower Extremity (FMA-LE)
Time frame: Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 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. The assessment will be conducted at baseline, mid-intervention (4 weeks), post-intervention (8 weeks) and 3-month follow-up (20 weeks).
6 secondary outcomes
The Change of Paretic ankle dorsiflexor strength
Time frame: Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)
The Change of Paretic ankle plantarflexor strength
Time frame: Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)
The Change of 10-m walk test
Time frame: Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)
The Change of Timed 'Up and Go' test
Time frame: Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)
The Change of Lower-extremity motor co-ordination test
Time frame: Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)
The Change of Cantonese version of Community Integration Measures (CIM-C)
Time frame: Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)
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 15 Oct 2026.
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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.
SSM 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 MT, 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 4 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 15 Oct 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?
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?
The Change of Fugl-Meyer Assessment of Lower Extremity (FMA-LE) (time frame: Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)). 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 15 Oct 2026; AzTrials last refreshed its copy on 29 Oct 2026.