Comparison of EEG-Timed vs. Repetitive Robot Therapy for Chronic Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EEG-Timed Robot Operation, Repetitive Robotic System.
- Who it may be relevant to
- Registry conditions: Stroke, Chronic Stroke, Hemiparesis. Basic parameters: 19 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
- Device EEG-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. - Device Repetitive Robotic System
A wearable robotic hand that provides repetitive hand opening and closing movements at fixed intervals, without requiring EEG signal triggering.
Primary outcome measures
- Change in Event-Related Desynchronization (ERD) During Motor Tasks [Time frame: Baseline, Week 2, Week 4, and Week 6]
Secondary outcome measures (2)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07459725 · B-2601-1020-302