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Recruiting NCT07078175

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

No phase Interventional Post-stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Xingnao Kaiqiao Acupuncture, Electroacupuncture.
Who it may be relevant to
Registry conditions: Post-stroke. Basic parameters: 40 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Vietnam
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Procedure 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
  • Procedure Electroacupuncture
    Routine electroacupuncture using standard acupoints for hemiplegic upper limb rehabilitation, including LI15, LI11, SJ5, and LI4, with low-frequency electrical stimulation.

Primary outcome measures

  • Change in Fugl-Meyer Assessment of Upper Extremity (FMA-UE) Score [Time frame: 4 weeks]
Secondary outcome measures (3)
  • Change in Barthel Index Score [Time frame: 4 weeks]
  • Proportion of Participants Achieving MCID in FMA-UE [Time frame: 4 weeks]
  • Proportion of Participants Achieving MCID in Barthel Index [Time frame: 4 weeks]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Vietnam · 1 center
  • Ho Chi Minh City Orthopedic and Rehabilitation Hospital — Ho Chi Minh City

Identifiers

NCT: NCT07078175 · XNKQ-StrokeRCT2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗