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 range30 Years – 80 Years
SexALL
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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
✓. Normal binocular visual acuity or corrected visual acuity
Exclusion criteria
✕. Patients with other severe cardiovascular and cerebrovascular diseases and unstable vital signs
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.
. 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.