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Effects of MI-BCI-Controlled Soft Robotics on Functional Recovery and Brain Activity in Stroke Patients

Effects of MI-BCI-Controlled Soft Robotics on Functional Recovery and Brain Activity in Stroke Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106951
Enrollment
Unknown
Registered
2025-07-31
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Stroke patients

Interventions

Experimental group:Brain computer interface + soft robotic glove + vibrotactile stimulation. 1 time/day, 5 days/week
Control group:Soft robotic glove + vibrotactile stimulation. 1 time/day, 5 days/week

Sponsors

The First Affiliated Hospital with Nanjing Medical University/Jiangsu Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) cerebral hemorrhage and cerebral infarction confirmed by CT and/or MRI; (2) first-ever or unilateral stroke, or a history of stroke without residual neurological deficits; (3) stable vital signs; (4) 40-75 years old; (5) post-stroke duration between 1 week and 3 months; (6) Brunnstrom stage I-IV for the affected upper limb; (7) Mini-Mental State Examination (MMSE) score >20; (8) informed consent obtained from the patient or their legal guardian.

Exclusion criteria

Exclusion criteria: (1) severe muscle spasticity with Modified Ashworth Scale (MAS) >2; (2) visual impairments; (3) posterior circulation stroke; (4) severe cardiopulmonary disease or multi-organ failure; (5) pregnancy; (6) other musculoskeletal disorders or significant joint pain in the hemiparetic upper limb; (7) other neurological disorders, such as brain tumors, psychiatric disorders or Parkinson’s disease.

Design outcomes

Primary

MeasureTime frame
Fugl-Meyer Assessment-Upper Extremity (FMA-UE);

Secondary

MeasureTime frame
Wolf Motor Function Test (WMFT);ICF Generic Set;Barthel Index;Modified Ashworth Scale (MAS);Semmes-Weinstein Monofilament Test (SWMT);Event-Related Spectral Perturbation (ERSP) & Event-Related Desynchronization (ERD);

Countries

China

Contacts

Public ContactShen Ying

The First Affiliated Hospital with Nanjing Medical University/Jiangsu Provincial People's Hospital

shenying@njmu.edu.cn+86 139 1391 3930

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 20, 2026