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Prospective, Randomized, Parallel-Controlled Study of Brain Computer Interface Integrated Robotic Mirror Therapy for Post-Stroke Upper Limb Motor Function Disorder

NCT07553416 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-05-01
Last updated
2026-04-28

Condition(s) studied

Ischemic StrokeIntracranial HaemorrhageBrain-Computer InterfacesRehabilitation Exercise

Investigational drug(s) / intervention(s)

Brain computer interface-robotic mirror therapy

Brain computer interface-robotic mirror therapy: BCI-RMT was performed by acquiring electroencephalographic signals from the unaffected hemisphere via a brain-computer interface, analyzing the signals with artificial intelligence, and finally delivering assisted motor function rehabilitation for the affected upper extremity via an intelligent exoskeleton training robot.

Study 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.

Eligibility

Sex
ALL
Min age
30 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Aged 30 to 80 years 2. Patients with unilateral upper limb motor dysfunction caused by primary ischemic/hemorrhagic stroke within 1 to 6 months prior to enrollment 3. 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 4. Modified Rankin Scale (mRS) score of 0 to 2 before stroke onset 5. Fugl-Meyer Motor Function Assessment of Upper Extremities (FMA-UE) score of 10 to 42 6. Montreal Cognitive Assessment (MoCA) score \> 18 7. Fugl-Meyer Balance Assessment score \> 6 8. Normal binocular visual acuity or corrected visual acuity 9. Normal hearing and intact verbal comprehension ability 10. Provided written informed consent Exclusion Criteria: 1. Patients with other severe cardiovascular and cerebrovascular diseases and unstable vital signs 2. Patients with motor dysfunction caused by other etiologies, such as amyotrophic lateral sclerosis, myasthenia gravis, muscular dystrophy, hypokalemic periodic paralysis, spondylitis, arthritis, osteomyelitis, etc. 3. Patients with severe diseases of the lungs, liver, kidneys and other vital organs 4. Patients with limb movement impairment caused by diseases such as fractures and arthritis 5. Modified Ashworth Scale (MAS) score \> 3 6. Patients unable to understand and cooperate with limb rehabilitation training due to factors such as severe aphasia 7. Presence of severe visual field defects or visual impairments (e.g., hemianopsia, hemispatial neglect, etc. 8. History of previous stroke 9. A history of severe motor injury and/or surgical intervention of the affected upper limb, such as muscle tear, tendon rupture, rhabdomyolysis 10. Life expectancy of less than 1 year due to the underlying disease 11. Undergoing major surgery within the past 30 days or planning to undergo major surgery within the next 90 days 12. Pregnant or lactating women 13. History of drug or alcohol abuse, head trauma or central nervous system infection; current use of cognition-impairing medications such as psychoactive or sedative drugs 14. With definite psychiatric and psychological disorders, such as depression, anxiety disorder, obsessive-compulsive disorder, schizophrenia, autism, chronic sleep disorder, consciousness disorder, etc. 15. Having implanted electronic devices in the body that interfere with magnetic resonance imaging (MRI), such as cochlear implants, cardiac pacemakers/defibrillators, drug delivery pumps 16. Poor compliance of the subject, their family members and caregivers, or inability to complete at least 12 months of follow-up as required by the study 17. Having been enrolled in other clinical studies that conflict with this study 18. Judged by the Indication Evaluation Committee as ineligible for or not falling within the scope of this study.

Primary outcome measure(s)

  • Changes in Fugl-Meyer Assessment of the Upper Extremity for the affected upper limb at the forth week after enrollment. — 4 weeks
    The primary outcome measure of this study was the Fugl-Meyer Assessment of the Upper Extremity (FMA-UE), which was employed to assess upper limb motor function in patients. The FMA-UE consists of 33 items, each graded on a 0-2 scale (0 = unable to perform, 1 = partially accomplished, 2 = fully accomplished), with a total score ranging from 0 to 66; higher scores indicate superior upper limb motor function. This scale enables comprehensive evaluation of joint range of motion, reflex activity, isolated motor control, and coordination in the hemiplegic upper extremity of stroke patients.

Trial sites (1)

FacilityCityRegionStatus
Beijing Tiantan Hospital, Capital Medical University Beijing Beijing Municipality
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07553416 on ClinicalTrials.gov ↗ ← All trials in China