Chronic Stroke, Hemiparesis, Stroke
Conditions
Brief 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. 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.
Interventions
DEVICEEEG-Timed Robot Operation
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.
DEVICERepetitive Robotic System
A wearable robotic hand that provides repetitive hand opening and closing movements at fixed intervals, without requiring EEG signal triggering.
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with stroke. * Adults aged 19 to 85 years old at the time of screening.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Event-Related Desynchronization (ERD) During Motor Tasks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Upper Extremity Motor Function Assessed by the Fugl-Meyer Assessment (FMA-UE) | Baseline, Week 2, Week 4, and Week 6 | 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. |
| Change in Upper Extremity Motor Performance Assessed by the Action Research Arm Test (ARAT) | Baseline, Week 2, Week 4, and Week 6 | 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. |
Outcome results
None listed