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

NCT ID: NCT07078175

Last Updated: 2025-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-08-01

Brief Summary

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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

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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.

Conditions

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Post-stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants were randomized in a 1:1 ratio to receive either Xingnao Kaiqiao acupuncture or standard electroacupuncture for 4 weeks. Treatment assignments were parallel with no crossover
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The outcome assessor was blinded to the treatment allocation to minimize assessment bias. Neither participants nor care providers were masked due to the nature of acupuncture interventions.

Study Groups

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Xingnao Kaiqiao Acupuncture

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.

Group Type EXPERIMENTAL

Xingnao Kaiqiao Acupuncture

Intervention Type PROCEDURE

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

Electroacupuncture

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.

Group Type ACTIVE_COMPARATOR

Electroacupuncture

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Electroacupuncture

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr Nguyen Ngo Le Minh Anh MD, PhD

OTHER

Sponsor Role lead

Responsible Party

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Dr Nguyen Ngo Le Minh Anh MD, PhD

Lecturer, MD, PhD- Faculty of Traditional Medicine, University of Medicine and Pharmacy at Ho Chi Minh City

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Minh-Anh Nguyen Ngo Le, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Medicine and Pharmacy at Ho Chi Minh City, Viet Nam

Locations

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Ho Chi Minh City Orthopedic and Rehabilitation Hospital

Ho Chi Minh City, Ho Chi Minh, Vietnam

Site Status RECRUITING

Countries

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Vietnam

Central Contacts

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Minh-Anh Nguyen Ngo Le, M.D., Ph.D.

Role: CONTACT

0084-962644648

Facility Contacts

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Minh-Anh Nguyen Ngo Le, M.D., Ph.D

Role: primary

0084-962644648

Minh-Anh Nguyen Ngo Le, M.D., Ph.D.

Role: backup

0884-962644648

Other Identifiers

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XNKQ-StrokeRCT2025

Identifier Type: -

Identifier Source: org_study_id

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