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

NCT07553416 | Not Yet Recruiting

• 1 other identifier: BJXZ-CY-07
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ischemic Stroke; Intracranial Haemorrhage; Brain-Computer Interfaces; Rehabilitation Exercise

Keywords

Ischemic Stroke; Intracranial Haemorrhage; Brain-Computer Interfaces; Rehabilitation Exercise; Mirror rehabilitation robot

Outcome Measures

Primary Outcomes (1)

• Changes in Fugl-Meyer Assessment of the Upper Extremity for the affected upper limb at the forth week after enrollment.

  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.

  4 weeks

Secondary Outcomes (7)

• The improvement in the Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) for the affected upper limb at the eighth week after enrollment.

  8 weeks

• Changes in neural conduction pathways at the forth week after enrollment.

  4 weeks

• Differences in changes of electroencephalographic (EEG) signals at the forth week after enrollment.

  4 weeks

• Improvements in the Wolf Motor Function Test of the affected upper extremity at the forth week and the eighth week after enrollment.

  4 weeks and 8 weeks

• Improvements in Modified Barthel Index (MBI) scores at the forth week and the eighth week after enrollment.

  4 weeks and 8 weeks

Study Arms (2)

Control group

NO INTERVENTION

The control group received conventional comprehensive rehabilitation therapy for 30 minutes per session, twice daily, 5 days per week, for 4 consecutive weeks.This therapy combined techniques including Bobath, Brunnstrom, Motor Relearning Program (MRP), and Proprioceptive Neuromuscular Facilitation (PNF), and involved training of movements such as shoulder flexion, extension and abduction, elbow flexion and extension, forearm pronation and supination, wrist flexion and extension, flexion and extension of interphalangeal and metacarpophalangeal joints, finger-to-finger opposition and thumb opposition, as well as roller training, ball grasping training, sanding board training, wooden peg moving training and card flipping training.

Experimental Group

EXPERIMENTAL

The experimental group received brain computer interface-robotic mirror therapy (BCI-RMT) 5 days per week for 4 consecutive weeks, combined with conventional comprehensive rehabilitation therapy at 30 minutes per session, twice daily, 5 days per week. Each BCI-RMT session included a basic phase and an intensive phase, with a total training duration of approximately 20 minutes. The intervention was implemented using a brain-computer interface intelligent exoskeleton active and passive training system (Model: AiHand Expanse-BCI-L1) developed by Shuli Zhixing (Xi'an) Intelligent Technology Co., Ltd., a subsidiary of Shanghai Shuli Intelligent Technology Co., Ltd. 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.

Device: Brain computer interface-robotic mirror therapy

Interventions

Brain computer interface-robotic mirror therapy DEVICE

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.

Experimental Group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Normal hearing and intact verbal comprehension ability
• Provided written informed consent

You may not qualify if:

• 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.
• History of previous stroke
• A history of severe motor injury and/or surgical intervention of the affected upper limb, such as muscle tear, tendon rupture, rhabdomyolysis
• Life expectancy of less than 1 year due to the underlying disease
• Undergoing major surgery within the past 30 days or planning to undergo major surgery within the next 90 days
• Pregnant or lactating women
• 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
• With definite psychiatric and psychological disorders, such as depression, anxiety disorder, obsessive-compulsive disorder, schizophrenia, autism, chronic sleep disorder, consciousness disorder, etc.
• Having implanted electronic devices in the body that interfere with magnetic resonance imaging (MRI), such as cochlear implants, cardiac pacemakers/defibrillators, drug delivery pumps

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

Related Publications (19)

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MeSH Terms

Conditions

Ischemic Stroke; Intracranial Hemorrhages

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yong Cao, Pro.

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sihao Liu, PhD

CONTACT

+86 010-59975531; liusihao0521@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: April 28, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

CN (1)