Post-stroke Aphasia
Conditions
Keywords
Aphasia, Stroke, Catgut Thread Embedding, Electroacupuncture, Speech-Language Rehabilitation
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURECatgut Thread Embedding
Catgut Thread Embedding involved implanting chromic catgut size 4.0 thread, which is attached to a 23G guide needle, into subcutaneous tissue at EX-HN21 acupoint. The guide needle was removed after insertion, while the thread remained and dissolved over 10-15 days to provide continuous stimulation.
PROCEDUREElectroacupuncture
Electroacupuncture was administered using four needles (0.3 × 25 mm, diameter × length) inserted at GV-20, EX-HN21, external EX-HN12, and external EX-HN13 acupoints. Electrical stimulation was delivered via the KWD-808I Multipurpose Health Device (Changzhou Yingdi Electronic Medical Device Co., China) with parameters set at 3 Hz frequency and 0.6 ms pulse width, the intensity was adjusted according to the patient's perception. Electroacupuncture was performed daily, except on Saturdays, Sundays, and Vietnamese national holidays, over a treatment course of 30 days.
Sponsors
School of Medicine - Vietnam National University at Ho Chi Minh city
Traditional Medicine Hospital at Dak Lak Province
Loc Cong Dai Tran, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Boston Diagnostic Aphasia Examination (BDAE) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events of Thread Embedding | Throughout the 30-day intervention period | Incidence of adverse events (e.g., bleeding, infection, needle shock) monitored clinically during and after the intervention period. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Baseline Characteristics | Day 0 | Baseline data were collected through patient interviews, medical records, and diagnostic tests. Demographic variables included age, categorized as ≤49, 50-69, or ≥70 years, gender, and education level, ranging from primary to post-secondary. Comorbid conditions were assessed as follows: hypertension was identified by blood pressure ≥140/90 mmHg or use of antihypertensive drugs, cardiovascular disease was determined by patient history and ECG results, diabetes was diagnosed if HbA1c ≥6.5%, fasting glucose ≥126 mg/dL, 2-hour glucose ≥200 mg/dL, random glucose ≥200 mg/dL with symptoms, or if patients were on diabetes medication, and dyslipidemia was confirmed by LDL ≥160 mg/dL, HDL \<40 mg/dL, triglycerides ≥200 mg/dL, or total cholesterol ≥240 mg/dL. Stroke-related details encompassed the type, either hemorrhagic or ischemic, time since stroke, classified as ≤1 month or \>1 month, and recurrence, noted as first-time or recurrent. |
Countries
Vietnam
Outcome results
None listed