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The effectiveness of a hand function rehabilitation system controlled by an fNIRS-based brain-computer interface

The effectiveness of a hand function rehabilitation system controlled by an fNIRS-based brain-computer interface: A multicenter randomized controlled clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098801
Enrollment
Unknown
Registered
2025-03-13
Start date
2025-03-04
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

Interventions

Sham Feedback group:A Traditional Hand Function Rehabilitation System
BCI group:A Hand Function Rehabilitation System Controlled by fNIRS-BCI

Sponsors

The First Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 79 Years

Inclusion criteria

Inclusion criteria: 1. Age: 30-79 years old; 2. Right-handed; 3. First-time stroke patients with onset between 2 weeks and 3 months; 4. Brunnstrom stage of the hemiplegic upper limb: proximal II-IV, and hand I-III; 5. Clear consciousness, sitting balance level 1 or above; 6. MMSE score >= 20, able to cooperate with assessments and treatments; 7. The patient or their authorized representative has signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. skull defect; 2. Severe cognitive or psychiatric disorders, unable to pay attention to or comprehend on-screen information;S; 3. ignificant spasticity, pain, or restricted joint movement in the affected upper limb.

Design outcomes

Primary

MeasureTime frame
Proportion of improvement in Brunnstrom stages of hand;—

Secondary

MeasureTime frame
Change value in Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score.;—

Countries

China

Contacts

Public ContactYuan Ziwen

The First Affiliated Hospital of Xi'an Jiaotong University

yuanziwen@xjtufh.edu.cn+86 29 85324834

Outcome results

None listed

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