A Randomized Controlled Trial Comparing the Efficacy of Thread Embedding and Electroacupuncture in Speech-Language Rehabilitation in Patients with Post-Stroke Aphasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Boston Diagnostic Aphasia Examination (BDAE)
研究概览
简要总结
The goal of this clinical trial was to learn if thread embedding or electroacupuncture can treat language function impairment in patients with post-stroke aphasia, a condition affecting communication after a stroke. The main questions it aimed to answer were:
Does thread embedding improve overall language function more effectively than electroacupuncture, as measured by the Goodglass and Kaplan Aphasia Severity Rating Scale (ASRS)? How do thread embedding and electroacupuncture compare in improving specific language skills, such as motor speech, sensory language, reading, and naming, as assessed by the Boston Diagnostic Aphasia Examination (BDAE)? Researchers compared thread embedding (TE group) to electroacupuncture (EA group) to see if thread embedding provides better or similar effects on language recovery.
Participants:
Underwent a 30-day intervention with language assessments at the start and end of the period.
Were randomly assigned to either the thread embedding group, receiving treatment every 10 days, or the electroacupuncture group, receiving daily 20-minute sessions.
详细描述
This study was designed as a randomized, open-label, parallel-group trial conducted at the Traditional Medicine Hospital in Dak Lak, Vietnam. It received ethical approval from the Biomedical Research Ethic Committee at the University of Medicine and Pharmacy at Ho Chi Minh City (Approval No. 739/HĐĐĐ-ĐHYD, dated December 14, 2021). The interventions were delivered by certified traditional medicine practitioners following strict protocols (STRICTA 2010).
Catgut Thread Embedding (TE group): Participants received thread embedding at the EX-HN21 acupoint.
Electroacupuncture (EA group): Participants underwent daily 20-minute sessions in 30 days.
Language function was assessed using standardized tools, and data were analyzed with R. Statistical tests (chi-square, t-tests) compared baseline characteristics and outcomes, with a significance level of p < 0.05.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with post-stroke aphasia (severity levels 0-4 on the Goodglass and Kaplan scale)
- •Aged 18 years or older
- •Fluent in Vietnamese
- •Alert and mentally competent (no psychiatric or neurological disorders affecting communication)
- •No pre-existing speech or language disorders
- •Willing to participate and provide signed informed consent
- •Treated as inpatients at the Traditional Medicine Hospital, Dak Lak
排除标准
- •Severe physical exhaustion or skin ulcers/infections at intervention sites
- •Presence of a pacemaker
- •Allergy to catgut threads
- •Post-stroke patients awaiting cranioplasty
- •Complex disease progression requiring alternative treatments during the study (data analyzed as treatment failures)
结局指标
主要结局
Boston Diagnostic Aphasia Examination (BDAE)
时间窗: Day 0 and Day 30
The Boston Diagnostic Aphasia Examination (BDAE) is a comprehensive and standardized tool designed to evaluate specific language functions in individuals with aphasia. It provides detailed insights into various language domains, including: Motor speech: Assesses articulation and fluency. Sensory language: Evaluates comprehension of spoken language. Reading skills: Measures the ability to read and understand written text. Naming skills: Tests the ability to name objects or concepts. Each domain is scored on a scale from 0 to 4, where: 0: Indicates severe impairment (e.g., complete inability to speak or comprehend). 4: Reflects mild or no impairment (near-normal language function). In practice, the BDAE is administered through structured tasks such as picture naming, sentence repetition, auditory comprehension tests, and reading exercises.
Goodglass and Kaplan's Aphasia Severity Rating Scale (ASRS)
时间窗: Day 0 and Day 30
The Goodglass and Kaplan's Aphasia Severity Rating Scale (ASRS) is a widely used tool that assesses the overall severity of aphasia. It employs a single scale ranging from 0 to 5 to summarize the general impact of aphasia on a patient's communication abilities: 0: Very severe aphasia (e.g., no meaningful speech or comprehension). 1-2: Severe aphasia (e.g., limited speech and poor comprehension). 3-4: Moderate to mild aphasia (e.g., functional communication with noticeable deficits). 5: Minimal or no aphasia (near-normal language function). The ASRS is typically scored based on clinical observation and interaction with the patient, focusing on their performance in everyday communication tasks like spontaneous speech, following commands, and answering questions.
次要结局
- Adverse Events of Thread Embedding(Throughout the 30-day intervention period)
研究者
Loc Cong Dai Tran, MD
Medical Doctor, Master of Sciences
School of Medicine - Vietnam National University at Ho Chi Minh city