Thread Embedding Vs. Electroacupuncture for Post-Stroke Aphasia

Not Applicable

Completed

• Conditions: Post-stroke Aphasia

• Registration Number: NCT06864442
• Lead Sponsor: Loc Cong Dai Tran, MD

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.

Study Timeline

• Study Start: 2021-08-01
• Primary Completion: 2022-07-31
• Study Completion: 2022-07-31
• Status Verified: 2025-03
• Study First Submitted: 2025-03-02
• Study First Submitted QC: 2025-03-02
• Last Update Submitted: 2025-03-02
• Study First Posted: 2025-03-07
• Last Update Posted: 2025-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Traditional Medicine Hospital; 🇻🇳 Buon Ma Thuot, Dak Lak, Vietnam