Post-stroke Aphasia, PSA
Conditions
Keywords
Post-stroke aphasia, Electroacupuncture, Speech therapy, Language recovery, Clinical trial
Brief summary
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.
Detailed description
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.
Interventions
OTHERElectroacupuncture
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.
OTHERBasic treatment + Speech therapy
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).
OTHERSham Electroacupuncture
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.
Sponsors
University of Medicine and Pharmacy at Ho Chi Minh City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Outcome assessors and data analysts will be blinded to treatment group assignment. Study participants will remain unaware of their specific group allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age: 18 to 75 years. * Diagnosis: Diagnosed with post-stroke aphasia (PSA) based on the Ministry of Health criteria or ICD-10 codes (I60-I64). * Cognitive and Functional State: Alert and able to cooperate with the treatment. * Language Assessment: Aphasia classified as moderate or mild according to the BDAE scale (scores 2-4). * Disease Duration: Stroke occurring 7 to 90 days prior to enrollment. * Language Proficiency: Native Vietnamese speaker. * Informed Consent: Must voluntarily sign the informed consent form and agree to comply with all study requirements.
Exclusion criteria
* Non-Stroke Related Aphasia: Pre-existing aphasia or aphasia not caused by a stroke. * Severe Comorbidities: Severe heart, liver, or kidney failure. * Psychiatric/Cognitive Disorders: Diagnosed dementia or other mental health conditions. * Medical Contraindications: Presence of a pacemaker. * Dermatological Conditions: Infection at the targeted acupoint sites. * Sensory Impairment: Significant hearing or visual impairment that interferes with assessment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in BDAE scores | From Baseline (T0) to Week 2 (T1), and Week 4 (T2). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change in ART scores | From Baseline (T0) to Week 2 (T1) and Week 4 (T2). | This is a quantitative variable measured in scores, used to evaluate language recovery in patients with post-stroke aphasia. |
| The change in SAQOL-39 scores | From Baseline (T0) to Week 4 (T2), and Week 12 (3-month Post-treatment Follow-up) (T3) | A quantitative variable assessing quality of life for patients with stroke and aphasia. |
| Adverse effects | From Baseline (T0) to Week 2 (T1) and Week 4 (T2). | 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. |
Countries
Vietnam
Contacts
CONTACTLinh T Nguyen, MD, MSc
Outcome results
None listed