Post-stroke aphasia (PSA) is a prevalent and debilitating condition that significantly impairs communication, social participation, and quality of life, often leading to increased long-term healthcare costs and psychological burden. While speech therapy is the recommended standard of care, many patients face limitations in recovery, prompting exploration into integrative approaches. Traditional medicine, particularly electroacupuncture, has shown potential in enhancing neuro-functional recovery; however, further evidence is needed to optimize its integration with standard rehabilitative protocols. This study evaluates the clinical efficacy of electroacupuncture at the Xuanzhong (GB39) and Tongli (HT5) acupoints combined with standardized speech therapy, aiming to improve language outcomes and patient quality of life. The goal of this clinical trial is to evaluate the clinical efficacy of electroacupuncture at the Xuanzhong (GB39) and Tongli (HT5) acupoints combined with speech therapy in patients with post-stroke aphasia, aged 18 to 75. The main questions it aims to answer are: * Does electroacupuncture at the Xuanzhong and Tongli acupoints, combined with speech therapy and standard treatment, improve language recovery more effectively than the standard protocol alone, as measured by the BDAE and ART scales? * Does this combined approach significantly improve the quality of life (SAQOL-39) and correlate with functional language recovery in post-stroke patients? Researchers will compare the intervention group (electroacupuncture at Xuanzhong and Tongli combined with basic treatment and speech therapy) to a control group (electroacupuncture at other acupoints combined with basic treatment and speech therapy) to see if the specific acupoint combination enhances language rehabilitation. Participants will: * Undergo 4 weeks of electroacupuncture (once daily, 5 days per week) and speech therapy sessions. * Complete assessments of language function (BDAE, ART) and quality of life (SAQOL-39) at baseline, 2 weeks, 1 month, and 3 months. * Be monitored for any adverse effects, such as local pain, bleeding, bruising, or needle fainting, throughout the trial period.
Participants and Methods: A randomized, single-blind, controlled trial will be conducted at the Military Medical Hospital 175, HCMC Hospital Orthopedics and Rehabilitation, and HCMC Hospital for Rehabilitation - Professional Diseases, involving patients aged 18 to 75 years diagnosed with post-stroke aphasia (PSA). Participants must meet defined inclusion criteria and not fall under any exclusion criteria, such as severe comorbid heart, liver, or kidney failure. Randomization and Grouping: Participants will be randomly assigned into two groups in a 1:1 ratio using block randomization with stratification by study site. The intervention group will receive electroacupuncture at the Xuanzhong (GB39) and Tongli (HT5) acupoints, combined with standardized speech therapy and basic medical treatment. The control group will receive electroacupuncture at non-acupoint locations, combined with the same standardized speech therapy and basic medical treatment. Procedure and Assessments: Both groups will receive 4 weeks of intervention, with electroacupuncture sessions conducted once daily, 5 days per week. Speech therapy will be performed daily for 30 minutes, 5 days per week. Clinical outcomes including the BDAE scale and ART will be assessed at baseline (T0), after 2 weeks (T1), and 1 month after treatment (T2). Quality of life (SAQOL-39) will be assessed at baseline (T0), 1 month after treatment (T2), and at a 3-month follow-up (T3). Adverse effects, such as local pain, bleeding, bruising, dizziness, or needle fainting, will be carefully monitored and recorded throughout the study period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
Electroacupuncture: Performed using a KWD-808I electroacupuncture device, set at a frequency of 2 Hz and an intensity of 2 mA. Acupoint Formula: Xuanzhong (3 cun above the apex of the lateral malleolus) and Tongli (1 cun above the transverse crease of the wrist, on the radial side of the flexor carpi ulnaris tendon). Procedure: Needles are inserted rapidly to achieve deqi, with a retention time of 20 minutes per session.
Participants receive standard basic treatment (management of blood pressure, lipids, blood glucose, and antiplatelet therapy) alongside speech therapy (30 minutes/session, 5 days/week for 4 weeks).
Performed using the same electroacupuncture device, but with the intensity set to 0 mA to maintain blinding. Insertion Sites: Non-acupoint 1 (1 cm lateral to the Xuanzhong point towards the fibula) and Non-acupoint 2 (1 cm medial to the Tongli point towards the ulna). Procedure: Needles are inserted rapidly without deqi manipulation, with a retention time of 20 minutes per session.
Faculty of Traditional medicine - University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City, Vietnam
The change in BDAE scores
This is a quantitative variable measured in scores. The BDAE (Boston Diagnostic Aphasia Examination) scale evaluates language function through 8 components. Higher improvement in the total score indicates better language rehabilitation.
Time frame: From Baseline (T0) to Week 2 (T1), and Week 4 (T2).
The change in ART scores
This is a quantitative variable measured in scores, used to evaluate language recovery in patients with post-stroke aphasia.
Time frame: From Baseline (T0) to Week 2 (T1) and Week 4 (T2).
The change in SAQOL-39 scores
A quantitative variable assessing quality of life for patients with stroke and aphasia.
Time frame: From Baseline (T0) to Week 4 (T2), and Week 12 (3-month Post-treatment Follow-up) (T3)
Adverse effects
This is a categorical variable (Yes/No) recording clinical adverse events such as local pain, bleeding, bruising, dizziness, or needle fainting during the trial period.
Time frame: From Baseline (T0) to Week 2 (T1) and Week 4 (T2).
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