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

29 juin 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

30

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Linh T Nguyen, MD, MSc
  • Numéro de téléphone: +84-909979717
  • E-mail: thailinh@ump.edu.vn

Lieux d'étude

  • Viêt Nam
      • Ho Chi Minh City, Viêt Nam, 700000
        • Faculty of Traditional medicine - University of Medicine and Pharmacy at Ho Chi Minh City
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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).
Autre: 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.

Autre: 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).
Comparateur factice: 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).
Autre: 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).
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
The change in BDAE scores
Délai: 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).

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
The change in ART scores
Délai: 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
Délai: 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
Délai: 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).

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Medicine and Pharmacy at Ho Chi Minh City

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juillet 2026

Achèvement primaire (Estimé)

1 décembre 2027

Achèvement de l'étude (Estimé)

1 janvier 2028

Dates d'inscription aux études

Première soumission

29 juin 2026

Première soumission répondant aux critères de contrôle qualité

29 juin 2026

Première publication (Réel)

6 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 358/ĐHYD-HĐĐĐ

Plan pour les données individuelles des participants (IPD)

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OUI

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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