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Effectiveness of Electroacupuncture at Xuanzhong (GB39) and Tongli (HT5) Points in Post-Stroke Aphasia

29. Juni 2026 aktualisiert von: Nguyen Thai Linh, University of Medicine and Pharmacy at Ho Chi Minh City

Evaluation of the Effectiveness of Electroacupuncture at Xuanzhong (GB39) and Tongli (HT5) Acupoints in Patients With Post-Stroke Aphasia

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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

30

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vietnam
      • Ho Chi Minh City, Vietnam, 700000
        • Faculty of Traditional medicine - University of Medicine and Pharmacy at Ho Chi Minh City
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Electroacupuncture (Xuanzhong, Tongli) + Basic Treatment with Speech therapy
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).
Sonstiges: Electroacupuncture

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.

Sonstiges: Basic treatment + Speech therapy
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).
Schein-Komparator: Sham Electroacupuncture + Basic Treatment with Speech therapy
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).
Sonstiges: Basic treatment + Speech therapy
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).
Sonstiges: Sham Electroacupuncture

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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
The change in BDAE scores
Zeitfenster: 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.
From Baseline (T0) to Week 2 (T1), and Week 4 (T2).

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
The change in ART scores
Zeitfenster: From Baseline (T0) to Week 2 (T1) and Week 4 (T2).
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
Zeitfenster: From Baseline (T0) to Week 4 (T2), and Week 12 (3-month Post-treatment Follow-up) (T3)
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
Zeitfenster: From Baseline (T0) to Week 2 (T1) and Week 4 (T2).
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).

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

1. Dezember 2027

Studienabschluss (Geschätzt)

1. Januar 2028

Studienanmeldedaten

Zuerst eingereicht

29. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. Juni 2026

Zuerst gepostet (Tatsächlich)

6. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

6. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 358/ĐHYD-HĐĐĐ

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JA

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF
  • CSR

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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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