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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electroacupuncture (Xuanzhong, Tongli) + Basic Treatment with Speech therapy | Experimental | Participants receive daily electroacupuncture at Xuanzhong (GB39) and Tongli (HT5) acupoints (2 Hz, 2mA, 20-minute retention) for 5 days per week over a 4-week period. This is combined with the hospital's basic treatment protocol, which includes standard medical management (blood pressure, lipid, and glucose control; antiplatelet therapy) and 30 minutes of daily speech therapy (5 days per week). |
|
| Sham Electroacupuncture + Basic Treatment with Speech therapy | Sham Comparator | Participants receive daily sham electroacupuncture at non-acupoint locations (1 cm from Xuanzhong and Tongli, 0 mA intensity) for 5 days per week over a 4-week period. This is combined with the same basic treatment protocol as the intervention group, including standard medical management and 30 minutes of daily speech therapy (5 days per week). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electroacupuncture | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Baseline (T0) to Week 2 (T1), and Week 4 (T2). |
| Measure | Description | Time Frame |
|---|---|---|
| The change in ART scores | This is a quantitative variable measured in scores, used to evaluate language recovery in patients with post-stroke aphasia. | From Baseline (T0) to Week 2 (T1) and Week 4 (T2). |
| The change in SAQOL-39 scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Linh T Nguyen, MD, MSc | Contact | +84-909979717 | thailinh@ump.edu.vn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Traditional medicine - University of Medicine and Pharmacy at Ho Chi Minh City | Ho Chi Minh City | 700000 | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36530615 | Background | Xu M, Gao Y, Zhang H, Zhang B, Lyu T, Tan Z, Li C, Li X, Huang X, Kong Q, Xiao J, Kranz GS, Li S, Chang J. Modulations of static and dynamic functional connectivity among brain networks by electroacupuncture in post-stroke aphasia. Front Neurol. 2022 Dec 1;13:956931. doi: 10.3389/fneur.2022.956931. eCollection 2022. | |
| 29230621 |
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Outcome assessors and data analysts will be blinded to treatment group assignment.
Study participants will remain unaware of their specific group allocation.
|
| Basic treatment + Speech therapy | Other | 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). |
|
| Sham Electroacupuncture | Other | 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. |
|
A quantitative variable assessing quality of life for patients with stroke and aphasia.
| 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. | From Baseline (T0) to Week 2 (T1) and Week 4 (T2). |
| Li LL, Liu XW, Wu F, Tong DC, Ye LP, Tao HX, Liu P, Qiu YH, Yang WZ. Electroacupuncture Stimulation of Language-Implicated Acupoint Tongli (HT 5) in Healthy Subjects: An fMRI Evaluation Study. Chin J Integr Med. 2018 Nov;24(11):822-829. doi: 10.1007/s11655-017-2924-8. Epub 2017 Dec 11. |
| 28868952 | Background | Liu S, Li M, Tang W, Wang G, Lv Y. An fMRI study of the effects on normal language areas when acupuncturing the Tongli (HT5) and Xuanzhong (GB39) acupoints. J Int Med Res. 2017 Dec;45(6):1961-1975. doi: 10.1177/0300060517720344. Epub 2017 Sep 4. |
| 34161953 | Background | Zhang Y, Wang Z, Jiang X, Lv Z, Wang L, Lu L. Effectiveness of Acupuncture for Poststroke Aphasia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Complement Med Res. 2021;28(6):545-556. doi: 10.1159/000512672. Epub 2021 Jun 23. |
| ID | Term |
|---|---|
| D003147 | Communication Disorders |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015671 | Electroacupuncture |
| D013070 | Speech Therapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
| D004599 | Electric Stimulation Therapy |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000758 | Anesthesia |
| D012049 | Rehabilitation of Speech and Language Disorders |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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