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Идёт набор NCT07078175

Xingnao Kaiqiao Acupuncture vs Electroacupuncture for Post-Stroke Upper Limb Recovery

Без фазы С лечением Post-stroke

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Xingnao Kaiqiao Acupuncture, Electroacupuncture.
Кому может быть актуально
Состояния в реестре: Post-stroke. Базовые параметры: 40 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Вьетнам
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Effectiveness of Xingnao Kaiqiao Acupuncture Compared to Electroacupuncture in Improving Upper Limb Function in Early Stroke Rehabilitation: A Randomized Controlled Trial

Обзор

This is a single-center interventional study conducted at the Ho Chi Minh City Hospital for Orthopedics and Rehabilitation, led by investigators from the University of Medicine and Pharmacy at Ho Chi Minh City. The study aims to evaluate the effectiveness of a specific acupuncture protocol (Xingnao Kaiqiao - Brain Awakening Acupuncture) in improving upper limb motor recovery in post-ischemic stroke patients during the early rehabilitation phase. Data collection has been completed, and the study is currently being registered on ClinicalTrials.gov to ensure research transparency, ethical compliance, and to facilitate future publication. The final results and publication will be updated once the study receives a registration number.

Подробное описание

This single-center interventional study was conducted at the Ho Chi Minh City Hospital for Orthopedics and Rehabilitation under the leadership of investigators from the University of Medicine and Pharmacy at Ho Chi Minh City. The objective of the study was to evaluate the effectiveness of the Xingnao Kaiqiao (Brain Awakening) acupuncture protocol in improving upper limb motor recovery in patients during the early rehabilitation phase following an ischemic stroke.

Eligible participants were screened and recruited according to predefined inclusion and exclusion criteria. Patients received standardized rehabilitation care, and the intervention group additionally received Xingnao Kaiqiao acupuncture targeting key acupoints associated with brain function and motor control. Outcomes were assessed using validated clinical scales and objective motor function tests.

The study adhered strictly to ethical guidelines and was approved by the Biomedical Research Ethics Committee of the University of Medicine and Pharmacy at Ho Chi Minh City (Approval No. 3332/HDDD-DHYD, dated November 6, 2024). Data collection and intervention have been completed, and the results are being prepared for formal analysis and publication. This registration serves to ensure research transparency and compliance with international standards for clinical trials.

Вмешательства

  • Процедура Xingnao Kaiqiao Acupuncture
    Acupuncture procedure developed by Prof. Shi Xuemin. Key acupoints include DU26, PC6, SP6, LI4, and GV20, applied with rapid and penetrating stimulation. Arm(s): Xingnao Kaiqiao Acupuncture
  • Процедура Electroacupuncture
    Routine electroacupuncture using standard acupoints for hemiplegic upper limb rehabilitation, including LI15, LI11, SJ5, and LI4, with low-frequency electrical stimulation.

Первичные конечные точки

  • Change in Fugl-Meyer Assessment of Upper Extremity (FMA-UE) Score [Срок оценки: 4 weeks]
Вторичные конечные точки (3)
  • Change in Barthel Index Score [Срок оценки: 4 weeks]
  • Proportion of Participants Achieving MCID in FMA-UE [Срок оценки: 4 weeks]
  • Proportion of Participants Achieving MCID in Barthel Index [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

  • Patients aged 40 to 80 years
  • Diagnosed with ischemic or hemorrhagic stroke confirmed by CT or MRI
  • Stroke onset between 1 and 6 months prior to enrollment
  • Moderate to severe upper limb motor impairment (FMA-UE score between 20 and 60)
  • Medically stable and able to attend treatment sessions 3 times per week
  • Capable of understanding the study procedures and providing informed consent

Критерии исключения

  • History of severe cognitive impairment (MMSE score < 20)
  • Comorbidities that affect motor function (e.g., Parkinson's disease, multiple sclerosis)
  • Severe aphasia or communication disorder that prevents assessment
  • Botulinum toxin injection in the upper limb within the past 3 months
  • Pacemaker or other contraindications to electroacupuncture
  • Currently participating in another clinical trial
  • Skin infections or local conditions at acupuncture sites

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Вьетнам · 1 центр
  • Ho Chi Minh City Orthopedic and Rehabilitation Hospital — Ho Chi Minh City

Идентификаторы

NCT: NCT07078175 · XNKQ-StrokeRCT2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗