Skip to content

Efficacy of SSVEP-BCI-Based Upper and Lower Limb Coordinated Training on Motor Function in Patients with Supratentorial Stroke: A Randomized, Controlled, Multicenter Trial

Efficacy of SSVEP-BCI-Based Upper and Lower Limb Coordinated Training on Motor Function in Patients with Supratentorial Stroke: A Randomized, Controlled, Multicenter Trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600129136
Enrollment
Unknown
Registered
2026-07-31
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Motor dysfunction after supratentorial stroke

Interventions

SSVEP-BCI Group:SSVEP-BCI-based coordinated upper and lower limb training plus conventional rehabilitation
Control Group:Conventional coordinated training plus conventional rehabilitation

Sponsors

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

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. First-ever supratentorial stroke, with onset within 2 weeks to 3 months, aged 40-75 years. 2. Presence of moderate to severe upper extremity motor dysfunction due to upper motor neuron injury, with Fugl-Meyer Upper Extremity (FMA-UE) score between 10 and 50, and Fugl-Meyer Lower Extremity (FMA-LE) score between 10 and 28. 3. Alert, with cognitive function meeting basic training requirements. The MMSE cutoff scores adjusted by education years are set as: illiterate >17, primary school education >20, secondary school and above >24. Visual acuity/corrected vision must meet the requirements for SSVEP-BCI training. 4. The patient or their legal guardian provides informed consent and agrees to cooperate with the study and follow-up.

Exclusion criteria

Exclusion criteria: 1. Severe comorbidities: severe cognitive impairment, limb contracture or deformity, severe cardiac/pulmonary/hepatic/renal insufficiency, malignant tumor, active mental illness, history of epilepsy; 2. Severe visual field defect or visual neglect that precludes participation in BCI tasks; 3. Modified Ashworth Scale grade =3 in the primary muscle groups of the affected limb (elbow flexors/extensors, knee flexors/extensors); 4. Concurrent participation in another interventional clinical study.

Design outcomes

Primary

MeasureTime frame
Modified Barthel Index;Fugl-Meyer Assessment Total Score;

Secondary

MeasureTime frame
Functional near-infrared spectroscopy (fNIRS) assessment of brain functional reorganization;Holden;Fugl-Meyer Assessment Lower Extremity Score;Ashworth;Modified Rankin Scale;Surface electromyography (sEMG) assessment of muscle synergy patterns;Electroencephalography (EEG) assessment of SSVEP response quality and brain network functional connectivity;Fugl-Meyer Assessment Upper Extremity Score;Berg Balance Scale;10MWT;

Countries

China

Contacts

Public ContactQiao Jin

The First Affiliated Hospital of Xi'an Jiaotong University

qiaojn123@163.com+86 29 85323215

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026