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Effecs of brain-computer interface controlled robot training on severe upper-limb dysfunction in subacute stroke patients

Effecs of brain-computer interface controlled robot training on severe upper-limb dysfunction in subacute stroke patients

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080117
Enrollment
Unknown
Registered
2024-01-22
Start date
2024-01-31
Completion date
Unknown
Last updated
2024-01-28

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

Conditions

stroke

Interventions

experiment group:Brain-computer interface controlled robot training: including motor imagery of grasping different objects in daily life, including tennis balls, bowls, spoons, etc., involving task mo
control group:Robotic hand training (sham BCI condition) : The same hardware arrangement as in BCI training was used, including placing an EEG cap on the subject's head and fixing the hemiplegic hand

Sponsors

Shanghai Yangzhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: ? According to the diagnostic criteria of stroke in the 2015 Chinese Classification of Cerebrovascular Diseases ? Patients with the first stroke confirmed by head CT or MRI, 1 week to 3 months after stroke onset ? Male and female, aged from 18 to 80 years old ? The lesion was only in one hemisphere ? Severe unilateral upper limb motor dysfunction, FMA-UE score < 36 points ? Modified Ashworth scale =3, sitting balance =2 ? No severe cognitive and speech impairment, able to understand and complete therapist instructions (MMSE=21) ? No history of drug and alcohol dependence, severe liver and kidney function diseases, other diseases that may affect brain structure and function, and other mental disorders

Exclusion criteria

Exclusion criteria: ? History of two or more strokes ? The patients had limb dysfunction caused by other reasons before the onset of the disease or had recent upper limb fractures, severe arthritis, joint replacement surgery, and other factors affecting the upper limb function And ? Patients with other musculoskeletal and central nervous system disorders affecting functional recovery ? Patients with comprehension impairment, visual impairment, hearing impairment, complete aphasia, and severe cognitive impairment ? unstable condition or inability to actively cooperate with the training ? taking skeletal muscle relaxant drugs within 2 weeks or having a history of botulinum toxin injection in the past 6 months ? Metal implants in the body ? Other circumstances that the investigator deemed impossible to participate in a clinical trial

Design outcomes

Primary

MeasureTime frame
Fugl-Meyer assessment-Upper Extremity;

Secondary

MeasureTime frame
Wolf Motor Function Test; Modified Barthel Index;resting motor threshold;motor evoked potential;central motor conduction time;

Countries

China

Contacts

Public ContactJin Lingjing

Shanghai Yangzhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center)

lingjingjin@163.com+86 150 2131 2377

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026