Combined Acupuncture-Based Therapy for Rehabilitation After Ischemic Stroke

• Electro-Field Acupuncture (Device): Electro-field acupuncture will be administered according to the standardized study procedure using predefined acupuncture points and electrical stimulation parameters.
• Electro-Acupuncture (Device): Electro-acupuncture will be administered according to the standardized study procedure using predefined acupuncture points and electrical stimulation parameters.
• Cerebrolysin (Drug): Cerebrolysin will be administered by acupoint injection according to the standardized study protocol.
• B complex vitamin (Drug): B complex vitamin will be administered by acupoint injection according to the standardized study protocol.
• Acupressure Massage (Other): Acupressure massage will be administered as background therapy to all participants according to the standardized treatment protocol.

Primary outcomes

• Change in Fugl-Meyer Assessment score for motor function in post-acute stroke patients [Baseline (Day 0) to Day 15 and Day 30]: Motor function will be assessed using the Fugl-Meyer Assessment (FMA). The FMA motor function score ranges from 0 to 100, with higher scores indicating better motor function. The primary outcome is the change in FMA motor function score from baseline (Day 0) to Day 15 and Day 30.

Secondary outcomes

• Change in Gugging Swallowing Screen (GUSS) score for swallow function in post-acute stroke patients [Baseline (Day 0) to Day 15 and Day 30]: Dysphagia will be assessed using the Gugging Swallowing Screen (GUSS), a 24-item clinical swallowing assessment. The total GUSS score ranges from 0 to 20, with a maximum score of 20. Higher scores indicate better swallowing function and less severe dysphagia, while lower scores indicate greater swallowing impairment. The change in GUSS score from baseline to Day 15 and Day 30 will be evaluated.

Sex: All, ages: 18 Years to any

Inclusion Criteria: Patients were eligible for inclusion in the study if they met all of the following criteria:

* Aged 18 years or older, regardless of sex and occupation.
* Diagnosed with post-acute ischemic stroke.
* Stabilized cardiovascular, respiratory, and neurological conditions, as well as vital signs following the acute phase.
* Hemiplegia/Hemiparesis (motor deficit on one side of the body).
* Fully conscious and capable of cooperating with clinicians, with a Mini-Mental State Examination (MMSE) score ≥ 20.
* Presence of dysphagia, confirmed by a Mann Assessment of Swallowing Ability (MASA) score ≤ 177.
* National Institutes of Health Stroke Scale (NIHSS) score ≥ 5.
* Clinical diagnosis of ischemic stroke confirmed by brain magnetic resonance imaging (MRI) showing ischemic lesions.
* Patients and/or their legal representatives voluntarily provided written informed consent to participate in the study.

Exclusion Criteria:

* Cerebral venous infarction, hemorrhagic transformation of cerebral infarction.
* Stage 3-4 heart failure, cerebral vascular malformations, cerebral air embolism, chronic obstructive pulmonary disease (COPD).
* Respiratory failure requiring endotracheal intubation, impaired consciousness.
* Concurrent systemic or neuropsychiatric conditions: tuberculosis, psychiatric disorders, HIV/AIDS, epilepsy, esophageal stricture, pyloric stenosis.
* Patients who have not received Cerebrolysin treatment during the acute phase.
* Non-cooperative patients, participants who fail to complete the full course of treatment, or patients whose clinical symptoms progressively worsen to a life-threatening level during the study.

• Study Protocol (PDF, 2025-11-26)
• Statistical Analysis Plan (PDF, 2026-09-15)

• Thanh Van Tran, MD, Associate Professor, Principal investigator, National Hospital of Acupuncture