Prospective, Randomized, Parallel-Controlled Study of Brain Computer Interface Integrated Robotic… (NCT07553416) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Prospective, Randomized, Parallel-Controlled Study of Brain Computer Interface Integrated Robotic Mirror Therapy for Post-Stroke Upper Limb Motor Function Disorder
China40 participantsStarted 2026-05-01
Plain-language summary
This study aims to utilize non-invasive brain-computer interface technology in conjunction with mirror therapy to design a new paradigm for rehabilitation robots to induce compensatory movements on the healthy side in stroke patients, evaluate the potential rehabilitation value of this paradigm for patients with severely impaired motor areas on the affected side, explore the neural rehabilitation compensation mechanism, and provide more personalized rehabilitation treatment strategies for patients with post-stroke motor dysfunction.
Who can participate
Age range
30 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged 30 to 80 years
. Patients with unilateral upper limb motor dysfunction caused by primary ischemic/hemorrhagic stroke within 1 to 6 months prior to enrollment
. Cerebral magnetic resonance diffusion-weighted imaging (DWI) at the time of onset indicating that the stroke lesion is limited to the unilateral basal ganglia region
. Modified Rankin Scale (mRS) score of 0 to 2 before stroke onset
. Fugl-Meyer Motor Function Assessment of Upper Extremities (FMA-UE) score of 10 to 42
. Montreal Cognitive Assessment (MoCA) score \> 18
. Fugl-Meyer Balance Assessment score \> 6
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in Fugl-Meyer Assessment of the Upper Extremity for the affected upper limb at the forth week after enrollment.
. Normal binocular visual acuity or corrected visual acuity
Exclusion criteria
. Patients with other severe cardiovascular and cerebrovascular diseases and unstable vital signs
. Patients with motor dysfunction caused by other etiologies, such as amyotrophic lateral sclerosis, myasthenia gravis, muscular dystrophy, hypokalemic periodic paralysis, spondylitis, arthritis, osteomyelitis, etc.
. Patients with severe diseases of the lungs, liver, kidneys and other vital organs
. Patients with limb movement impairment caused by diseases such as fractures and arthritis
. Modified Ashworth Scale (MAS) score \> 3
. Patients unable to understand and cooperate with limb rehabilitation training due to factors such as severe aphasia
. Presence of severe visual field defects or visual impairments (e.g., hemianopsia, hemispatial neglect, etc.