Comparison of EEG-Timed vs. Repetitive Robot Therapy for Chronic Stroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-85
SponsorSeoul National University Bundang Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients diagnosed with stroke.
Adults aged 19 to 85 years old at the time of screening.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
EEG-Timed Robot Operation
DeviceA 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 System
DeviceA wearable robotic hand that provides repetitive hand opening and closing movements at fixed intervals, without requiring EEG signal triggering.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: EEG-Timed Robot TherapyExperimental treatment 1 intervention
Group B: Repetitive Robot TherapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, Week 2, Week 4, and Week 6Secondary outcomes
1
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.
Time frame
Baseline, Week 2, Week 4, and Week 62
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.
Time frame
Baseline, Week 2, Week 4, and Week 6Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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