StrokeNCT07459725
Comparison of EEG-Timed vs. Repetitive Robot Therapy for Chronic Stroke
A study testing EEG-Timed Robot Operation and Repetitive Robotic System in people with Stroke and Chronic Stroke, run by Seoul National University Bundang Hospital.
Trial summary
This clinical trial compares two types of robotic hand rehabilitation-brain wave (EEG)-timed therapy versus simple repetitive therapy-to see which is more effective for recovering hand function in patients with chronic stroke. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Stroke, Chronic Stroke, Hemiparesis
- What is being tested?
- EEG-Timed Robot Operation and Repetitive Robotic System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 16 Mar 2026to 31 Dec 2028
- 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 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with stroke.
- Adults aged 19 to 85 years old at the time of screening.
Who cannot join
- Patients with severe, uncontrolled medical conditions.
- Patients with uncontrolled hypertension, diabetes mellitus, or renal disease.
- Patients with severe cognitive impairment that prevents them from following instructions for motor tasks (Mini-Mental State Examination [MMSE] score of 15 or below).
- Note: Patients with an MMSE score of 15 or below may still be included if the Principal Investigator (or a delegated physician) determines that they have the capacity to perform the tasks and provide informed consent.
About this study
Official title: Exploratory Comparison of Movement Observation/Imagery-Timed Robot Activation and Repetitive Robot Activation on Training Effects and Neurophysiological Responses in Chronic Stroke Patients
This clinical trial compares two types of robotic hand rehabilitation-brain wave (EEG)-timed therapy versus simple repetitive therapy-to see which is more effective for recovering hand function in patients with chronic stroke. Participants will be randomly assigned to either group and will attend sessions using a wearable robotic hand device while wearing an EEG cap. In the EEG-timed group, the robot assists hand movements when participants successfully imagine moving and create specific brain signals, whereas in the repetitive group, the robot moves the hand automatically at set intervals. Both groups will receive a matched dose of robotic training to ensure a fair comparison of how the brain and hand function respond to the therapy.
- Conditions
- Stroke, Chronic Stroke, Hemiparesis
- Being tested
- EEG-Timed Robot Operation, Repetitive Robotic System
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG-Timed Robot OperationDevice
A wearable hand robot that activates in real-time when the patient successfully generates a specific brain signal (ERD) during movement observation and motor imagery.
Repetitive Robotic SystemDevice
A wearable robotic hand that provides repetitive hand opening and closing movements at fixed intervals, without requiring EEG signal triggering.
| Study group | Role | What they receive |
|---|---|---|
| EEG-Timed Robot Therapy | Experimental | Not described Receives: Device: EEG-Timed Robot Operation |
| Repetitive Robot Therapy | Active comparator | Not described Receives: Device: Repetitive Robotic System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Event-Related Desynchronization (ERD) During Motor Tasks
Event-Related Desynchronization (ERD) is continuously measured using multi-channel EEG over the sensorimotor cortex while participants perform action observation and motor imagery (AO+MI) tasks. ERD represents the decrease in EEG power in specific frequency bands (e.g., mu or beta rhythms), which reflects the level of cortical activation. A greater magnitude of ERD indicates stronger and more active neurophysiological engagement of the motor cortex.
Measured: Baseline, Week 2, Week 4, and Week 6
Secondary outcomes (2)
Change in Upper Extremity Motor Function Assessed by the Fugl-Meyer Assessment (FMA-UE)
The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) is a stroke-specific, performance-based index designed to assess motor impairment. It evaluates movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, and hand. The total FMA-UE score ranges from 0 to 66. Higher scores indicate better motor function and less impairment.
Measured: Baseline, Week 2, Week 4, and Week 6
Change in Upper Extremity Motor Performance Assessed by the Action Research Arm Test (ARAT)
The Action Research Arm Test (ARAT) is an observational, performance-based measure used to assess upper extremity function, specifically focusing on grasping, gripping, pinching, and gross movement. The total score ranges from 0 to 57. Higher scores indicate better arm and hand motor performance and greater upper limb dexterity.
Measured: Baseline, Week 2, Week 4, and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start16 Mar 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Dec 2028 (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 Seoul National University Bundang 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nam-Jong Paik, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07459725
- Sponsor's protocol ID
- B-2601-1020-302
- Status last verified
- Feb 2026
- First submitted
- 5 Mar 2026
- Last updated
- 10 Mar 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 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Comparison of Movement Observation/Imagery-Timed Robot Activation and Repetitive Robot Activation on Training Effects and Neurophysiological Responses in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT07459725
- Acronym / sponsor ID
- B-2601-1020-302
- Conditions
- Stroke, Chronic Stroke, Hemiparesis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 16 Mar 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 Mar 2026 (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 clinical trial compares two types of robotic hand rehabilitation-brain wave (EEG)-timed therapy versus simple repetitive therapy-to see which is more effective for recovering hand function in patients with chronic stroke. Participants will be randomly assigned to either group and will attend sessions using a wearable robotic hand device while wearing an EEG cap. In the EEG-timed group, the robot assists hand movements when participants successfully imagine moving and create specific brain signals, whereas in the repetitive group, the robot moves the hand automatically at set intervals. Both groups will receive a matched dose of robotic training to ensure a fair comparison of how the brain and hand function respond to the therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EEG-Timed Robot Therapy | Experimental | Device: EEG-Timed Robot Operation |
| Repetitive Robot Therapy | Active comparator | Device: Repetitive Robotic System |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with stroke.
- Adults aged 19 to 85 years old at the time of screening.
Key exclusion criteria (4 listed)
- Patients with severe, uncontrolled medical conditions.
- Patients with uncontrolled hypertension, diabetes mellitus, or renal disease.
- Patients with severe cognitive impairment that prevents them from following instructions for motor tasks (Mini-Mental State Examination [MMSE] score of 15 or below).
- Note: Patients with an MMSE score of 15 or below may still be included if the Principal Investigator (or a delegated physician) determines that they have the capacity to perform the tasks and provide informed consent.
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 |
|---|---|---|
| EEG-Timed Robot OperationA wearable hand robot that activates in real-time when the patient successfully generates a specific brain signal (ERD) during movement observation and motor imagery. | Device | EEG-Timed Robot Therapy |
| Repetitive Robotic SystemA wearable robotic hand that provides repetitive hand opening and closing movements at fixed intervals, without requiring EEG signal triggering. | Device | Repetitive Robot Therapy |
Primary outcome
Change in Event-Related Desynchronization (ERD) During Motor Tasks
Time frame: Baseline, Week 2, Week 4, and Week 6
Event-Related Desynchronization (ERD) is continuously measured using multi-channel EEG over the sensorimotor cortex while participants perform action observation and motor imagery (AO+MI) tasks. ERD represents the decrease in EEG power in specific frequency bands (e.g., mu or beta rhythms), which reflects the level of cortical activation. A greater magnitude of ERD indicates stronger and more active neurophysiological engagement of the motor cortex.
2 secondary outcomes
Change in Upper Extremity Motor Function Assessed by the Fugl-Meyer Assessment (FMA-UE)
Time frame: Baseline, Week 2, Week 4, and Week 6
Change in Upper Extremity Motor Performance Assessed by the Action Research Arm Test (ARAT)
Time frame: Baseline, Week 2, Week 4, and Week 6
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 10 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing EEG-Timed Robot Operation and Repetitive Robotic System in people with Stroke and Chronic Stroke, run by Seoul National University Bundang Hospital.
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 2 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: opening soon, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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 in Event-Related Desynchronization (ERD) During Motor Tasks (time frame: Baseline, Week 2, Week 4, and Week 6). 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 10 Mar 2026.