The effect of brain computer interface combined with exoskeleton robot hand in the treatment of stroke patients with hand dysfunction from central intervention to peripheral feedback

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200066479

Enrollment

Unknown

Registered

2022-12-06

Start date

2022-12-15

Completion date

Unknown

Last updated

2023-05-15

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

Conditions

Stroke

Interventions

BCI group:Conventional rehabilitation + Brain computer interface combined with exoskeleton robot hand therapy

Control group:Conventional rehabilitation

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age: between 18 and 75 years old; 2. It conforms to the diagnostic criteria for stroke formulated by the Fourth National Conference on Cerebrovascular Diseases in 1995; 3. For the first unilateral hemiplegic patient, 1 month <= course <= 12 months; 4. Accompanied with moderate and severe hand dysfunction (Brunnstrom <= grade 4), spasticity grade = grade 3; 5. No serious cognitive impairment and can correctly complete the hand grasping and other actions as instructed; 6. No severe liver and kidney disease, no brain trauma, drug and alcohol dependence history or other diseases that may affect brain structure and function, and no other mental disorders; 7. No diabetes or peripheral neuropathy; 8. Patients who can sit alone or assisted for more than 1 hour and voluntarily participate without standardized rehabilitation training and informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with second or more stroke; 2. There is upper limb and hand movement dysfunction caused by other reasons before the onset; 3. Combined with other mental disorders; 4. Subjectively unable to understand or cooperate with the whole process training of brain computer interface; 5. Patients with obvious cognitive function limitation (MoCA<21 points) have visual or hearing impairment; 6. Sensory aphasia and mixed aphasia; 7. The affected limb has unstable fracture, infection, active bleeding and other diseases.

Design outcomes

Primary

Measure	Time frame
Fugl Meyer Upper Limb Motor Function Assessment Scale Upper Limb Part (FMA-UE);	—

Secondary

Measure	Time frame
Action Research Arm Test;Wolf Motor Function Test, WMFT;Mental Rotation Test;Montreal Cognitive Assessment, MoCA;EEG data analysis;	—

Countries

China

Contacts

Public ContactGuidi zou

Huizhou Third People's Hospital

zouyueen@126.com+86 15820706685

Outcome results

None listed

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