Xingnao Kaiqiao Acupuncture vs Electroacupuncture for Post-Stroke Upper Limb Recovery (XNKQ-RCT)

Dr Nguyen Ngo Le Minh Anh MD, PhD

Status: Enrolling

Conditions: Post-stroke

Treatments: Procedure: Xingnao Kaiqiao Acupuncture; Procedure: Electroacupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT07078175

XNKQ-StrokeRCT2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Xingnao Kaiqiao Acupuncture

Experimental group

Description:

Participants in this group received Xingnao Kaiqiao (XNKQ) acupuncture based on the standardized protocol developed by Prof. Shi Xuemin, focusing on awakening the brain and opening the sensory orifices. Treatment was administered once daily for 5 days/week over 4 weeks.

Treatment:

Procedure: Xingnao Kaiqiao Acupuncture

Electroacupuncture

Active Comparator group

Description:

Participants in this group received routine electroacupuncture therapy applied to standard upper-limb motor recovery acupoints. Treatment was administered once daily for 5 days/week over 4 weeks.

Treatment:

Procedure: Electroacupuncture