Evaluation of the Effectiveness of Electroacupuncture at Xuanzhong (GB39) and Tongli (HT5) Acupoints in Patients With Post-Stroke Aphasia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The change in BDAE scores
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Outcome assessors and data analysts will be blinded to treatment group assignment.
Study participants will remain unaware of their specific group allocation.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The change in BDAE scores
时间窗: 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.
次要结局
- The change in ART scores(From Baseline (T0) to Week 2 (T1) and Week 4 (T2).)
- The change in SAQOL-39 scores(From Baseline (T0) to Week 4 (T2), and Week 12 (3-month Post-treatment Follow-up) (T3))
- Adverse effects(From Baseline (T0) to Week 2 (T1) and Week 4 (T2).)
研究者
Nguyen Thai Linh
MD, MSc
University of Medicine and Pharmacy at Ho Chi Minh City