Ischemic StrokeBCI-RMTNCT07553416
Prospective, Randomized, Parallel-Controlled Study of Brain Computer Interface Integrated Robotic Mirror Therapy for Post-Stroke Upper Limb Motor Function Disorder
A study testing Brain computer interface-robotic mirror therapy in people with Ischemic Stroke and Intracranial Haemorrhage, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Ischemic Stroke, Intracranial Haemorrhage, Brain-Computer Interfaces
- What is being tested?
- Brain computer interface-robotic mirror therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
- 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
- Having been enrolled in other clinical studies that conflict with this study
- Judged by the Indication Evaluation Committee as ineligible for or not falling within the scope of this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality
Sihao Liu, PhD, +86 010-59975531, liusihao0521@163.com
Yong Cao, Pro.
About this study
Official title: 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.
Read the 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.
- Conditions
- Ischemic Stroke, Intracranial Haemorrhage, Brain-Computer Interfaces, Rehabilitation Exercise
- Being tested
- Brain computer interface-robotic mirror therapy
- Keywords
- Ischemic Stroke, Intracranial Haemorrhage, Brain-Computer Interfaces, Rehabilitation Exercise, Mirror rehabilitation robot
- Medical subject headings
- Ischemic Stroke, Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain computer interface-robotic mirror therapyDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Brain computer interface-robotic mirror therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 8 weeks
Changes in neural conduction pathways at the forth week after enrollment.
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.
Measured: 4 weeks
Differences in changes of electroencephalographic (EEG) signals at the forth week after enrollment.
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.
Measured: 4 weeks
Improvements in the Wolf Motor Function Test of the affected upper extremity at the forth week and the eighth week after enrollment.
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.
Measured: 4 weeks and 8 weeks
Improvements in Modified Barthel Index (MBI) scores at the forth week and the eighth week after enrollment.
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.
Measured: 4 weeks and 8 weeks
Changes in Modified Ashworth Scale (MAS) scores at the forth week and the eighth week after enrollment.
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.
Measured: 4 weeks and 8 weeks
Changes in Montreal Cognitive Assessment (MoCA) scores at the forth week and the eighth week after enrollment.
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.
Measured: 4 weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yong Cao, Pro., Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553416
- Sponsor's protocol ID
- BJXZ-CY-07
- Acronym
- BCI-RMT
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ward NS, Cohen LG. Mechanisms underlying recovery of motor function after stroke. Arch Neurol. 2004 Dec;61(12):1844-8. doi: 10.1001/archneur.61.12.1844.
PubMed 15596603Mohapatra S, Harrington R, Chan E, Dromerick AW, Breceda EY, Harris-Love M. Role of contralesional hemisphere in paretic arm reaching in patients with severe arm paresis due to stroke: A preliminary report. Neurosci Lett. 2016 Mar 23;617:52-8. doi: 10.1016/j.neulet.2016.02.004. Epub 2016 Feb 9.
PubMed 26872851Kaiser V, Daly I, Pichiorri F, Mattia D, Muller-Putz GR, Neuper C. Relationship between electrical brain responses to motor imagery and motor impairment in stroke. Stroke. 2012 Oct;43(10):2735-40. doi: 10.1161/STROKEAHA.112.665489. Epub 2012 Aug 14.
PubMed 22895995Ma ZZ, Wu JJ, Cao Z, Hua XY, Zheng MX, Xing XX, Ma J, Xu JG. Motor imagery-based brain-computer interface rehabilitation programs enhance upper extremity performance and cortical activation in stroke patients. J Neuroeng Rehabil. 2024 May 29;21(1):91. doi: 10.1186/s12984-024-01387-w.
PubMed 38812014Liu X, Zhang W, Li W, Zhang S, Lv P, Yin Y. Effects of motor imagery based brain-computer interface on upper limb function and attention in stroke patients with hemiplegia: a randomized controlled trial. BMC Neurol. 2023 Mar 31;23(1):136. doi: 10.1186/s12883-023-03150-5.
PubMed 37003976Kruse A, Suica Z, Taeymans J, Schuster-Amft C. Effect of brain-computer interface training based on non-invasive electroencephalography using motor imagery on functional recovery after stroke - a systematic review and meta-analysis. BMC Neurol. 2020 Oct 22;20(1):385. doi: 10.1186/s12883-020-01960-5.
PubMed 33092554Martini ML, Oermann EK, Opie NL, Panov F, Oxley T, Yaeger K. Sensor Modalities for Brain-Computer Interface Technology: A Comprehensive Literature Review. Neurosurgery. 2020 Feb 1;86(2):E108-E117. doi: 10.1093/neuros/nyz286.
PubMed 31361011Colucci A, Vermehren M, Cavallo A, Angerhofer C, Peekhaus N, Zollo L, Kim WS, Paik NJ, Soekadar SR. Brain-Computer Interface-Controlled Exoskeletons in Clinical Neurorehabilitation: Ready or Not? Neurorehabil Neural Repair. 2022 Dec;36(12):747-756. doi: 10.1177/15459683221138751. Epub 2022 Nov 25.
PubMed 36426541Wang A, Tian X, Jiang D, Yang C, Xu Q, Zhang Y, Zhao S, Zhang X, Jing J, Wei N, Wu Y, Lv W, Yang B, Zang D, Wang Y, Zhang Y, Wang Y, Meng X. Rehabilitation with brain-computer interface and upper limb motor function in ischemic stroke: A randomized controlled trial. Med. 2024 Jun 14;5(6):559-569.e4. doi: 10.1016/j.medj.2024.02.014. Epub 2024 Apr 19.
PubMed 38642555GBD 2021 Diseases and Injuries Collaborators. Global incidence, prevalence, years lived with disability (YLDs), disability-adjusted life-years (DALYs), and healthy life expectancy (HALE) for 371 diseases and injuries in 204 countries and territories and 811 subnational locations, 1990-2021: a systematic analysis for the Global Burden of Disease Study 2021. Lancet. 2024 May 18;403(10440):2133-2161. doi: 10.1016/S0140-6736(24)00757-8. Epub 2024 Apr 17.
PubMed 38642570Kim DH, Lee KD, Bulea TC, Park HS. Increasing motor cortex activation during grasping via novel robotic mirror hand therapy: a pilot fNIRS study. J Neuroeng Rehabil. 2022 Jan 24;19(1):8. doi: 10.1186/s12984-022-00988-7.
PubMed 35073933Kurniawan S, Mubarak H, Sam N, Waluyo Y, Zainuddin AA, Mochtar AA. Enhancing Hand Motor Recovery Poststroke: A Comparative Study of Robotic vs Conventional Mirror Therapy. Arch Phys Med Rehabil. 2025 Aug;106(8):1183-1188. doi: 10.1016/j.apmr.2024.11.008. Epub 2024 Nov 29.
PubMed 39615826He YZ, Huang ZM, Deng HY, Huang J, Wu JH, Wu JS. Feasibility, safety, and efficacy of task-oriented mirrored robotic training on upper-limb functions and activities of daily living in subacute poststroke patients: a pilot study. Eur J Phys Rehabil Med. 2023 Dec;59(6):660-668. doi: 10.23736/S1973-9087.23.08018-8. Epub 2023 Oct 23.
PubMed 37869761Chen YW, Li KY, Lin CH, Hung PH, Lai HT, Wu CY. The effect of sequential combination of mirror therapy and robot-assisted therapy on motor function, daily function, and self-efficacy after stroke. Sci Rep. 2023 Oct 6;13(1):16841. doi: 10.1038/s41598-023-43981-3.
PubMed 37803096Zhuang JY, Ding L, Shu BB, Chen D, Jia J. Associated Mirror Therapy Enhances Motor Recovery of the Upper Extremity and Daily Function after Stroke: A Randomized Control Study. Neural Plast. 2021 Sep 29;2021:7266263. doi: 10.1155/2021/7266263. eCollection 2021.
PubMed 34630560
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07553416
- Acronym / sponsor ID
- BCI-RMT / BJXZ-CY-07
- Conditions
- Ischemic Stroke, Intracranial Haemorrhage, Brain-Computer Interfaces, Rehabilitation Exercise
- Keywords
- Ischemic Stroke, Intracranial Haemorrhage, Brain-Computer Interfaces, Rehabilitation Exercise, Mirror rehabilitation robot
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Brain computer interface-robotic mirror therapyThe 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. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain computer interface-robotic mirror therapyBCI-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 | Experimental Group |
Primary outcome
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.
7 secondary outcomes
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
Changes in neural conduction pathways at the forth week after enrollment.
Time frame: 4 weeks
Differences in changes of electroencephalographic (EEG) signals at the forth week after enrollment.
Time frame: 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
Improvements in Modified Barthel Index (MBI) scores at the forth week and the eighth week after enrollment.
Time frame: 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
Changes in Montreal Cognitive Assessment (MoCA) scores at the forth week and the eighth week after enrollment.
Time frame: 4 weeks and 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Background: PubMed 15596603Ward NS, Cohen LG. Mechanisms underlying recovery of motor function after stroke. Arch Neurol. 2004 Dec;61(12):1844-8. doi: 10.1001/archneur.61.12.1844.
- Background: PubMed 26872851Mohapatra S, Harrington R, Chan E, Dromerick AW, Breceda EY, Harris-Love M. Role of contralesional hemisphere in paretic arm reaching in patients with severe arm paresis due to stroke: A preliminary report. Neurosci Lett. 2016 Mar 23;617:52-8. doi: 10.1016/j.neulet.2016.02.004. Epub 2016 Feb 9.
- Background: PubMed 22895995Kaiser V, Daly I, Pichiorri F, Mattia D, Muller-Putz GR, Neuper C. Relationship between electrical brain responses to motor imagery and motor impairment in stroke. Stroke. 2012 Oct;43(10):2735-40. doi: 10.1161/STROKEAHA.112.665489. Epub 2012 Aug 14.
- Background: PubMed 38812014Ma ZZ, Wu JJ, Cao Z, Hua XY, Zheng MX, Xing XX, Ma J, Xu JG. Motor imagery-based brain-computer interface rehabilitation programs enhance upper extremity performance and cortical activation in stroke patients. J Neuroeng Rehabil. 2024 May 29;21(1):91. doi: 10.1186/s12984-024-01387-w.
- Background: PubMed 37003976Liu X, Zhang W, Li W, Zhang S, Lv P, Yin Y. Effects of motor imagery based brain-computer interface on upper limb function and attention in stroke patients with hemiplegia: a randomized controlled trial. BMC Neurol. 2023 Mar 31;23(1):136. doi: 10.1186/s12883-023-03150-5.
- Background: PubMed 33092554Kruse A, Suica Z, Taeymans J, Schuster-Amft C. Effect of brain-computer interface training based on non-invasive electroencephalography using motor imagery on functional recovery after stroke - a systematic review and meta-analysis. BMC Neurol. 2020 Oct 22;20(1):385. doi: 10.1186/s12883-020-01960-5.
- Background: PubMed 31361011Martini ML, Oermann EK, Opie NL, Panov F, Oxley T, Yaeger K. Sensor Modalities for Brain-Computer Interface Technology: A Comprehensive Literature Review. Neurosurgery. 2020 Feb 1;86(2):E108-E117. doi: 10.1093/neuros/nyz286.
- Background: PubMed 36426541Colucci A, Vermehren M, Cavallo A, Angerhofer C, Peekhaus N, Zollo L, Kim WS, Paik NJ, Soekadar SR. Brain-Computer Interface-Controlled Exoskeletons in Clinical Neurorehabilitation: Ready or Not? Neurorehabil Neural Repair. 2022 Dec;36(12):747-756. doi: 10.1177/15459683221138751. Epub 2022 Nov 25.
- Background: PubMed 38642555Wang A, Tian X, Jiang D, Yang C, Xu Q, Zhang Y, Zhao S, Zhang X, Jing J, Wei N, Wu Y, Lv W, Yang B, Zang D, Wang Y, Zhang Y, Wang Y, Meng X. Rehabilitation with brain-computer interface and upper limb motor function in ischemic stroke: A randomized controlled trial. Med. 2024 Jun 14;5(6):559-569.e4. doi: 10.1016/j.medj.2024.02.014. Epub 2024 Apr 19.
- Background: PubMed 38642570GBD 2021 Diseases and Injuries Collaborators. Global incidence, prevalence, years lived with disability (YLDs), disability-adjusted life-years (DALYs), and healthy life expectancy (HALE) for 371 diseases and injuries in 204 countries and territories and 811 subnational locations, 1990-2021: a systematic analysis for the Global Burden of Disease Study 2021. Lancet. 2024 May 18;403(10440):2133-2161. doi: 10.1016/S0140-6736(24)00757-8. Epub 2024 Apr 17.
- Background: PubMed 35073933Kim DH, Lee KD, Bulea TC, Park HS. Increasing motor cortex activation during grasping via novel robotic mirror hand therapy: a pilot fNIRS study. J Neuroeng Rehabil. 2022 Jan 24;19(1):8. doi: 10.1186/s12984-022-00988-7.
- Background: PubMed 39615826Kurniawan S, Mubarak H, Sam N, Waluyo Y, Zainuddin AA, Mochtar AA. Enhancing Hand Motor Recovery Poststroke: A Comparative Study of Robotic vs Conventional Mirror Therapy. Arch Phys Med Rehabil. 2025 Aug;106(8):1183-1188. doi: 10.1016/j.apmr.2024.11.008. Epub 2024 Nov 29.
- Individual participant dataSharing planned: Undecided
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Development and Validation of Risk Prediction Models for Stroke and Cognitive Impairment in Moyamoya Disease and Moyamoya Syndrome
Moyamoya Disease, Moyamoya Syndrome
Recruiting
Impact of Atrial Fibrosis Surface Area on the Occurrence of Atrial Fibrillation in Patients With Ischemic Stroke of Undetermined Origin: a Prospective Cardiac MRI Pilot Study.
Stroke, Implantation of an Implantable Cardiac Monitor
Recruiting
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
Brainstem Stroke, ALS
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yong Cao, Pro. principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain computer interface-robotic mirror therapy in people with Ischemic Stroke and Intracranial Haemorrhage, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sihao Liu, PhD (+86 010-59975531, liusihao0521@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Fugl-Meyer Assessment of the Upper Extremity for the affected upper limb at the forth week after enrollment. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07553416, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.