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Effect of Central–Peripheral–Central Closed-Loop Brain–Computer Interface Ankle Rehabilitation Training on Lower Limb Functional Reconstruction in Stroke Patients: A Multicenter, Prospective, Randomized Controlled Trial

Effect of Central–Peripheral–Central Closed-Loop Brain–Computer Interface Ankle Rehabilitation Training on Lower Limb Functional Reconstruction in Stroke Patients: A Multicenter, Prospective, Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125418
Enrollment
Unknown
Registered
2026-05-26
Start date
2026-05-31
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

stroke

Interventions

experimental group:4-week central–peripheral–central closed-loop brain–computer interface ankle rehabilitation training
control group:4-week conventional active and passive ankle training

Sponsors

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

Eligibility

Sex/Gender
All
Age
45 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for stroke (including ischemic or hemorrhagic) according to the Diagnostic Criteria for Major Cerebrovascular Diseases in China or relevant internationally recognized standards, and confirmed by cranial CT or MRI. 2. Aged 45 to 75 years (inclusive), either sex. 3. In the subacute phase of stroke: 4 to 12 weeks after onset, with stable vital signs and neurological function. 4. Presence of definite unilateral ankle motor dysfunction, clinically manifested as foot drop and/or varus during the swing phase of gait, and absolute active dorsiflexion range of motion of the affected ankle = 24, with basic understanding and cooperation ability. 7. The patient or their legal representative fully understands the study content, volunteers to participate, and signs written informed consent.

Exclusion criteria

Exclusion criteria: 1. Presence of severe cardiac, pulmonary, hepatic, or renal insufficiency, or uncontrolled systemic diseases such as hypertension or diabetes mellitus, making the patient unsuitable for rehabilitation training. 2. Comorbidity with other central or peripheral nervous system disorders that may affect motor function (e.g., Parkinson's disease, myasthenia gravis, spinal cord injury, etc.), or presence of severe joint contracture, deformity, unhealed fracture, pain, or skin breakdown on the affected lower limb. 3. History of epilepsy or presence of intracranial metal implants (excluding dental fillings); severe infection or large unhealed wound on the scalp that prevents wearing of electroencephalography (EEG) acquisition equipment. 4. Presence of severe cognitive impairment, aphasia, neglect syndrome, or psychiatric disorders that impair the ability to understand and follow training instructions. 5. Expected inability to complete the prescribed rehabilitation course, or concurrent participation in another rehabilitation or drug clinical trial that may interfere with the results of this study. 6. Any other condition that, in the investigator's assessment, may increase risk or interfere with study evaluations.

Design outcomes

Primary

MeasureTime frame
active ankle dorsiflexion range of motion;Manual Muscle Testing (MMT) of the Ankle;

Secondary

MeasureTime frame
Functional Ambulation Classification (FAC);Berg Balance Scale (BBS);Fugl-Meyer Motor Assessment of the Lower Limb;

Countries

China

Contacts

Public ContactHongfei Qiao

The Second Affiliated Hospital of Xi 'an Jiaotong University

66725578@qq.com+86 29 8767 9570

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026