Combined Acupuncture-Based Therapy for Rehabilitation After Ischemic Stroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Hospital of Acupuncture, Vietnam
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Factorial
Treatments tested in this trial
Electro-Field Acupuncture
DeviceElectro-field acupuncture will be administered according to the standardized study procedure using predefined acupuncture points and electrical stimulation parameters.
Electro-Acupuncture
DeviceElectro-acupuncture will be administered according to the standardized study procedure using predefined acupuncture points and electrical stimulation parameters.
Cerebrolysin
DrugCerebrolysin will be administered by acupoint injection according to the standardized study protocol.
B complex vitamin
DrugB complex vitamin will be administered by acupoint injection according to the standardized study protocol.
Acupressure Massage
Other interventionAcupressure massage will be administered as background therapy to all participants according to the standardized treatment protocol.
Treatment groups
440 Participants
are divided into 2 treatment groupsGroup A: Evaluation of the effect on motor function recovery in post-acute stroke patientsExperimental treatment 5 interventions
Group B: Evaluation of the therapeutic effect on dysphagia in post-acute stroke patientsExperimental treatment 5 interventions
Trial outcomes
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 30Secondary 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 30Sponsors and contacts
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Source ClinicalTrials.gov
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