StrokeNCT06011018
Comparison of Effects of Mirror Therapy Combined With Neuromuscular Electrical Stimulation or Binaural Beats Stimulation on Cortical Excitability, Heart Rate Variability and Lower Limb Motor Function in Patients With Stroke
A study testing Mirror Therapy, Mirror Therapy + Electrical Stimulation and Mirror Therapy + Binaural Beat in people with Stroke and Healthy Adults, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
This study aims to compare the effects of mirror therapy combined with either neuromuscular electrical stimulation or binaural beat stimulation on post-stroke lower limb motor function recovery. The study also explores the relationship between patients' cortical excitability and motor function improvement. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Healthy Adults
- What is being tested?
- Mirror Therapy, Mirror Therapy + Electrical Stimulation and Mirror Therapy + Binaural Beat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Oct 2022to 31 Jul 2026
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- First occurrence of stroke≧ 6 months
- Mini-mental state examination≧24
- Modified Ashworth's scale of ankle muscle ≦3
- Sit independently≧30 mins
- Brunnstrom stage ≧3
- Aged between 20 and 80 years
Who cannot join
- Speech impairment
- Hearing impairment
- Visual impairment
- Other orthopedic diseases or nerve damage
- Complete sensory impairment
- Pacemaker or metal implants
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University, Department of Physical Therapy
Kaohsiung City, 807
LIN JAU HONG, Ph.D., 0929393300, jhlin@kmu.edu.tw
LIN YEN YU, Master's, 0988392631, yenyu.lin88@yahoo.com
About this study
This study aims to compare the effects of mirror therapy combined with either neuromuscular electrical stimulation or binaural beat stimulation on post-stroke lower limb motor function recovery. The study also explores the relationship between patients' cortical excitability and motor function improvement.
- Conditions
- Stroke, Healthy Adults
- Being tested
- Mirror Therapy, Mirror Therapy + Electrical Stimulation, Mirror Therapy + Binaural Beat
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirror TherapyOther
Sitting, mirror place at the midline between the legs. Unaffected leg is placed in front of the mirror and perform ankle dorsiflexion exercises.
Duration: 5 seconds, Rest: 5 seconds
Mirror Therapy + Electrical StimulationOther
Same as the mirror therapy protocol. Affected leg: electrical stimulation on tibialis anterior muscle. Frequency: 35 Hz, Pulse width: 250µs, Duration: 5 seconds, Rest: 5 seconds.
Mirror Therapy + Binaural BeatOther
Same as the mirror therapy protocol. Listen to music (pink noise), with 14Hz binaural beat stimulation
| Study group | Role | What they receive |
|---|---|---|
| Mirror therapy | Experimental | Not described Receives: Other: Mirror Therapy |
| Mirror Therapy + Electrical Stimulation | Experimental | Not described Receives: Other: Mirror Therapy + Electrical Stimulation |
| Mirror Therapy + Binaural Beat | Experimental | Not described Receives: Other: Mirror Therapy + Binaural Beat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer assessment, lower extremity
The Fugl-Meyer Assessment for lower extremity is a scale used to evaluate motor and functional recovery in patients with conditions like stroke. It measures muscle strength, movement control, coordination, and balance. Scores range from 0 (no movement) to 34 (full recovery). Higher scores indicate better recovery.
Measured: 10minutes
Secondary outcomes (4)
Modified ashworth scale
The Modified Ashworth Scale assesses muscle spasticity in conditions like stroke or cerebral palsy. Scores range from 0 to 4 or 5, indicating the severity of muscle resistance during passive movement. Higher scores mean more severe spasticity. It guides treatment and tracks progress.
Measured: 5minutes
Timed up and go test
The Timed Up and Go (TUG) test assesses mobility by measuring the time it takes for someone to stand, walk a short distance, turn, and sit back down. Faster times suggest better mobility, while longer times may indicate mobility limitations or fall risk. It's a useful tool to evaluate functional capacity and guide interventions for improved mobility.
Measured: 5minutes
The postural assessment scale for stroke patients
Higher scores on the Postural Assessment Scale for Stroke Patients (PASS) indicate greater difficulty in postural control and stability after a stroke.
Measured: 10 minutes
Barthel index
The Barthel Index assesses a person's ability to independently perform daily activities. Scores range from 0 to 100, with higher scores indicating greater independence.
Measured: 5minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start25 Oct 2022
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (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 Kaohsiung Medical University Chung-Ho Memorial HospitalThe 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
- Model description
- Participants were randomly assigned treatment groups: 1. Mirror Therapy 2. Mirror Therapy + Electrical Stimulation 3. Mirror Therapy + Binaural Beat
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LIN JAU HONG, Ph.D., Study chair, Kaohsiung Medical University,department of Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011018
- Sponsor's protocol ID
- KMUHIRB-F(II)-20220175
- Status last verified
- Aug 2025
- First submitted
- 21 Aug 2023
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: During the study period, to ensure subject privacy, only the implementers of this research project, monitors, regulatory authorities, and the institutional review board of our institution have the authority to access the data
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effects of Mirror Therapy Combined With Neuromuscular Electrical Stimulation or Binaural Beats Stimulation on Cortical Excitability, Heart Rate Variability and Lower Limb Motor Function in Patients With Stroke
- ClinicalTrials.gov ID
- NCT06011018
- Acronym / sponsor ID
- KMUHIRB-F(II)-20220175
- Conditions
- Stroke, Healthy Adults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 25 Aug 2023 (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 compare the effects of mirror therapy combined with either neuromuscular electrical stimulation or binaural beat stimulation on post-stroke lower limb motor function recovery. The study also explores the relationship between patients' cortical excitability and motor function improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants were randomly assigned treatment groups: 1. Mirror Therapy 2. Mirror Therapy + Electrical Stimulation 3. Mirror Therapy + Binaural Beat
| Arm | Type | Receives |
|---|---|---|
| Mirror therapy | Experimental | Other: Mirror Therapy |
| Mirror Therapy + Electrical Stimulation | Experimental | Other: Mirror Therapy + Electrical Stimulation |
| Mirror Therapy + Binaural Beat | Experimental | Other: Mirror Therapy + Binaural Beat |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- First occurrence of stroke≧ 6 months
- Mini-mental state examination≧24
- Modified Ashworth's scale of ankle muscle ≦3
- Sit independently≧30 mins
- Brunnstrom stage ≧3
Key exclusion criteria (6 listed)
- Speech impairment
- Hearing impairment
- Visual impairment
- Other orthopedic diseases or nerve damage
- Complete sensory impairment
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 |
|---|---|---|
| Mirror TherapySitting, mirror place at the midline between the legs. Unaffected leg is placed in front of the mirror and perform ankle dorsiflexion exercises. Duration: 5 seconds, Rest: 5 seconds | Other | Mirror therapy |
| Mirror Therapy + Electrical StimulationSame as the mirror therapy protocol. Affected leg: electrical stimulation on tibialis anterior muscle. Frequency: 35 Hz, Pulse width: 250µs, Duration: 5 seconds, Rest: 5 seconds. | Other | Mirror Therapy + Electrical Stimulation |
| Mirror Therapy + Binaural BeatSame as the mirror therapy protocol. Listen to music (pink noise), with 14Hz binaural beat stimulation | Other | Mirror Therapy + Binaural Beat |
Primary outcome
Fugl-Meyer assessment, lower extremity
Time frame: 10minutes
The Fugl-Meyer Assessment for lower extremity is a scale used to evaluate motor and functional recovery in patients with conditions like stroke. It measures muscle strength, movement control, coordination, and balance. Scores range from 0 (no movement) to 34 (full recovery). Higher scores indicate better recovery.
4 secondary outcomes
Modified ashworth scale
Time frame: 5minutes
Timed up and go test
Time frame: 5minutes
The postural assessment scale for stroke patients
Time frame: 10 minutes
Barthel index
Time frame: 5minutes
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 4 Sep 2025.
- Individual participant dataSharing planned: No. During the study period, to ensure subject privacy, only the implementers of this research project, monitors, regulatory authorities, and the institutional review board of our institution have the authority to access the data
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
LIN JAU HONG, Ph.D. study chair
Kaohsiung Medical University,department of Physical Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mirror Therapy, Mirror Therapy + Electrical Stimulation and Mirror Therapy + Binaural Beat in people with Stroke and Healthy Adults, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 6 inclusion and 6 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 4 Sep 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 Taiwan. 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?
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 LIN JAU HONG, Ph.D. (0929393300, jhlin@kmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer assessment, lower extremity (time frame: 10minutes). 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 4 Sep 2025.