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Efficacy Evaluation of Brain-Computer Motor Feedback Training System on Upper Limb Rehabilitation in Stroke Patients

Efficacy Evaluation of Brain-Computer Motor Feedback Training System on Upper Limb Rehabilitation in Stroke Patients: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125467
Enrollment
Unknown
Registered
2026-05-27
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper limb motor dysfunction after stroke

Interventions

Test group:Brain-computer interface interaction for feedback-based upper limb rehabilitation training
Control group:Traditional upper limb circular motion training

Sponsors

Xuanwu Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. First onset, or previous onset without obvious sequelae; 2. Meets the diagnostic criteria for ischemic stroke or hemorrhagic stroke, with a disease course of 2 weeks to 6 months; 3. The patient's age is between 35 and 75 years old (including 35 and 75 years old), and gender is not limited; 4. Moderate to severe upper limb motor dysfunction caused by unilateral hemisphere stroke (FMA-UE <= 47 points); 5. Sitting balance is at level 1 or above; 6. Has signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. There are neurological deficits caused by bilateral hemispheric or subcortical lesions, stroke, brain tumors, brain trauma, fractures and other diseases; upper limb movement limitations, impairments, joint swelling, contractures, severe pain or other hand disorders; 2. The modified Ashworth scores of the affected side's upper limb shoulder, elbow, wrist and fingers are all between 3 and 4; 3. Patients with severe systemic diseases such as heart, lung, liver and kidney diseases that cannot be controlled by conventional medication; 4. Patients with consciousness disorders, severe aphasia, dysarthria, cognitive impairment, deafness, etc., unable to communicate normally, understand or follow instructions, or unable to cooperate with treatment and assessment; 5. Patients with malignant hypertension (sudden and significant increase in blood pressure, with both systolic and diastolic pressures increasing, often persisting above 200/130 mmHg); 6. Patients with malignant tumors; or patients with a life expectancy of less than one year due to causes other than stroke; 7. Patients with severe depression, anxiety states, or diagnosed with other mental disorders; 8. Patients with severe sensory disorders, severe neglect; 9. Patients with implanted or carrying pacemakers that may interfere with BCI; 10. Patients who received botulinum toxin injection treatment for the affected side's upper limb within 3 months before enrollment, or who considered using botulinum toxin injection treatment at any time during the study; 11. Patients with a history of alcohol abuse or drug abuse; 12. Patients with abnormal findings from other examinations that the investigator judges to be unsuitable for participation in this trial; 13. Pregnant or planning to become pregnant women of childbearing age; 14. Patients currently participating in other clinical research trials.

Design outcomes

Primary

MeasureTime frame
Fugl-Meyer Motor Assessment-Upper Extremity, FMA-UE;

Secondary

MeasureTime frame
Wolf Motor Function Test;Exercise capacity;Motor evoked potentials;Activity of daily life;Quality of life;EEG;TMS-EG;fNIRS;

Countries

China

Contacts

Public ContactLi Hui

Xuanwu Hospital, Capital Medical University

lihui1910@163.com+86 152 0080 6744

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026