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

April 22, 2026 updated by: Beijing Tiantan Hospital

A Prospective, Randomized, Parallel-Controlled Clinical Study Protocol of Non-Invasive Brain Computer Interface Robot Based on Mirror Rehabilitation Theory in the Treatment of Upper Limb Motor Function Disorder After Stroke

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, single-center, open-label, outcome-assessor-blinded, randomized, parallel-controlled clinical study initiated by investigators. Based on the post-stroke compensatory model theory, this study innovatively combines brain-computer interface and mirror robot technology to build a dynamic closed-loop feedback system. Using the contralesional compensatory activation mechanism and a designed robot training paradigm, it explores the efficacy of the intervention in improving upper limb motor function and its underlying neural recovery mechanisms.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Beijing Tiantan Hospital, Capital Medical University
        • Contact:
        • Principal Investigator:
          • Yong Cao, Pro.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
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: Experimental Group
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Fugl-Meyer Assessment of the Upper Extremity for the affected upper limb at the forth week after enrollment.
Time Frame: 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.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The improvement in the Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) for the affected upper limb at the eighth week after enrollment.
Time Frame: 8 weeks
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.
8 weeks
Changes in neural conduction pathways at the forth week after enrollment.
Time Frame: 4 weeks
Diffusion Tensor Imaging (DTI) enables visualization of cerebral white matter fiber tracts and assessment of the repair of neural conduction pathways. In this study, the unaffected primary motor cortex (M1) was used as the seed region, and the ipsilesional cervical spinal cord was set as the target region. Fractional Anisotropy (FA) values of the fiber tract were extracted. A higher FA value indicates greater integrity of the fiber tract and stronger neural conduction ability.
4 weeks
Differences in changes of electroencephalographic (EEG) signals at the forth week after enrollment.
Time Frame: 4 weeks
Electroencephalographic signal acquisition enables the analysis of time-frequency characteristics, spatial features, and functional connectivity in patients before and after rehabilitation intervention. Time-frequency analysis serves as a primary approach to evaluating the efficacy of BCI-RMT training. Spatial feature analysis enables the detailed visualization of the spatial distribution of ERD/ERS in the form of brain topographic maps, which is particularly well-suited for monitoring the spatial pattern of compensatory activation in the unaffected hemisphere and its longitudinal changes throughout the training process. Functional connectivity analysis is primarily employed to investigate information connectivity and exchange patterns among motor-related brain regions.
4 weeks
Improvements in the Wolf Motor Function Test of the affected upper extremity at the forth week and the eighth week after enrollment.
Time Frame: 4 weeks and 8 weeks
The Wolf Motor Function Test (WMFT) also enables quantitative evaluation of motor function in the hemiplegic upper extremity among stroke patients, with a specific emphasis on the quality of movement execution. As a complementary measure to the FMA-UE, it simulates daily functional activities more comprehensively, covering tasks from single-joint isolated movements (e.g., lateral elbow extension) to multi-joint complex actions (e.g., towel folding). The WMFT comprises 15 items scored according to movement fluency, coordination and accuracy, with each item rated on a 0-5 scale and a total score ranging from 0 to 75; higher scores reflect better upper extremity motor function.
4 weeks and 8 weeks
Improvements in Modified Barthel Index (MBI) scores at the forth week and the eighth week after enrollment.
Time Frame: 4 weeks and 8 weeks
The Modified Barthel Index (MBI) is utilized to evaluate patients' activities of daily living (ADL). This scale covers basic daily living activities, including feeding, bathing, dressing, toileting, bowel and bladder control, bed-chair transfer, walking on level ground, stair climbing, and grooming (tooth brushing and hair combing). The total score ranges from 0 to 100 points. A higher score indicates greater functional independence: a score of 0 represents complete dependence, whereas a score of 100 indicates full independence.
4 weeks and 8 weeks
Changes in Modified Ashworth Scale (MAS) scores at the forth week and the eighth week after enrollment.
Time Frame: 4 weeks and 8 weeks
The Modified Ashworth Scale (MAS) is a commonly used clinical scale for assessing limb muscle tone in stroke patients. It evaluates the severity of limb spasticity by sensing changes in resistance during passive joint movement.The MAS comprises six grades: Grade 0, Grade 1, Grade 1+, Grade 2, Grade 3, and Grade 4. A higher grade indicates increased muscle tone.
4 weeks and 8 weeks
Changes in Montreal Cognitive Assessment (MoCA) scores at the forth week and the eighth week after enrollment.
Time Frame: 4 weeks and 8 weeks
The Montreal Cognitive Assessment (MoCA) can evaluate patients' cognitive function, covering 8 cognitive domains including orientation, executive function, naming, attention, language, abstract thinking, delayed recall and visuospatial ability. It has a total score of 30 points, and a score of ≥26 points indicates normal cognitive function.
4 weeks and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Investigators

  • Principal Investigator: Yong Cao, Pro., Beijing Tiantan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

April 22, 2026

First Submitted That Met QC Criteria

April 22, 2026

First Posted (Actual)

April 28, 2026

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BJXZ-CY-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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