CClinicalTrials.gg
Not yet recruitingNCT07846488Updated Sep 29, 2026

Combined Acupuncture-Based Therapy for Rehabilitation After Ischemic Stroke

An interventional study of Electro-Field Acupuncture and Electro-Acupuncture in Ischemic Stroke, Hemiplegia and Neurogenic Dysphagia, sponsored by National Hospital of Acupuncture, Vietnam. Not yet recruiting at 1 site in Vietnam. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by National Hospital of Acupuncture, Vietnam · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
440
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Objective: To assess the therapeutic efficacy of combined electroacupuncture (or electric field acupuncture), hydroacupuncture (Cerebrolysin or B-complex vitamins), and acupressure massage in restoring motor function and treating dysphagia in post-acute ischemic stroke patients, while evaluating safety profiles and prognostic factors associated with clinical outcomes.

Interventions:

Participants will be randomly assigned to one of four treatment arms:

Group 1: Electric field acupuncture + Cerebrolysin Acupoint injection + acupressure massage Group 2: Electric field acupuncture + B-complex vitamin Acupoint injection + acupressure massage Group 3: Electroacupuncture + Cerebrolysin Acupoint injection + acupressure massage Group 4: Electroacupuncture + B-complex vitamin Acupoint injection + acupressure massage The intervention duration is 30 days.

02

Conditions studied

  • Ischemic Stroke
  • Hemiplegia
  • Neurogenic Dysphagia

Keywords

  • Electro - acupuncture
  • Acupressure
  • Acupoint injection
  • Motor Rehabilitation
  • neurogenic dysphagia
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
440 participants (estimated)

Study arms

  • Experimental
    Evaluation of the effect on motor function recovery in post-acute stroke patients

    Device: Electro-Field Acupuncture · Device: Electro-Acupuncture · Drug: Cerebrolysin · Drug: B complex vitamin · Other: Acupressure Massage

  • Experimental
    Evaluation of the therapeutic effect on dysphagia in post-acute stroke patients

    Device: Electro-Field Acupuncture · Device: Electro-Acupuncture · Drug: Cerebrolysin · Drug: B complex vitamin · Other: Acupressure Massage

Interventions

  • DeviceElectro-Field Acupuncture

    Electro-field acupuncture will be administered according to the standardized study procedure using predefined acupuncture points and electrical stimulation parameters.

  • DeviceElectro-Acupuncture

    Electro-acupuncture will be administered according to the standardized study procedure using predefined acupuncture points and electrical stimulation parameters.

  • DrugCerebrolysin

    Cerebrolysin will be administered by acupoint injection according to the standardized study protocol.

  • DrugB complex vitamin

    B complex vitamin will be administered by acupoint injection according to the standardized study protocol.

  • OtherAcupressure Massage

    Acupressure massage will be administered as background therapy to all participants according to the standardized treatment protocol.

05

What researchers measure

Primary outcomes

  1. Change in Fugl-Meyer Assessment score for motor function in post-acute stroke patients

    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.

    Time frame: Baseline (Day 0) to Day 15 and Day 30

Secondary outcomes

  1. Change in Gugging Swallowing Screen (GUSS) score for swallow function in post-acute stroke patients

    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.

    Time frame: Baseline (Day 0) to Day 15 and Day 30

06

Study locations

1 site
  • National Hospital of Acupuncture
    Hanoi, Hanoi 10000, Vietnam
07

References and documents

Study documents

  • Study protocol · Nov 26, 2025
  • Statistical analysis plan · Sep 15, 2026

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — No. Individual participant data will not be shared outside the research team.

08

Registry details

Key details

Study ID
NCT07846488
Lead sponsor
National Hospital of Acupuncture, Vietnam
Responsible party
MSc.MD Nguyen Thi Ngoc Linh (Head of the Scientific Research Department, National Hospital of Acupuncture, Vietnam) — Principal investigator
First posted
Sep 29, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Jun 30, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Sep 29, 2026

Study contacts

Ngoc Linh Thi Nguyen, MD, MSc
Contact
nguyenthingoclinh.bs249@gmail.com
+84358961018
Thanh Hoa Thi Phi, MD, PhD
Contact
Drthanhhoa@hotmail.com
+84968217057
Thanh Van Tran, MD, Associate Professor
principal investigator · National Hospital of Acupuncture

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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