NCT Number: NCT07078175
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.
Interested in participating?
Request Info40 year–80 year
All sexes
Interventional
Not applicable
Ho Chi Minh City, Ho Chi Minh, 700000, Vietnam
Location status: Recruiting
Minh-Anh Nguyen Ngo Le, M.D., Ph.D
CONTACT
Minh-Anh Nguyen Ngo Le, M.D., Ph.D.
CONTACT
Minh-Anh Nguyen Ngo Le, M.D., Ph.D.
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Routine electroacupuncture using standard acupoints for hemiplegic upper limb rehabilitation, including LI15, LI11, SJ5, and LI4, with low-frequency electrical stimulation.
Time frame: 4 weeks
Change in FMA-UE score from baseline to 4 weeks post-treatment. The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) is a validated scale that measures upper limb motor function in post-stroke patients.
The scale ranges from 0 (severe impairment) to 66 (normal function). Higher scores indicate better recovery of motor function.
Time frame: 4 weeks
Change in Barthel Index score from baseline to 4 weeks post-treatment to assess improvement in activities of daily living (ADL). The Barthel Index ranges from 0 (completely dependent) to 100 (fully independent). Higher scores indicate better functional independence
Time frame: 4 weeks
Percentage of participants showing a clinically meaningful improvement in upper extremity motor function, defined as a ≥5-point increase in FMA-UE score from baseline to 4 weeks. This threshold is based on established Minimal Clinically Important Difference (MCID) criteria for post-stroke populations.
Time frame: 4 weeks
Percentage of participants demonstrating a clinically important improvement in daily functional independence, defined as a ≥10-point increase in Barthel Index score from baseline to 4 weeks. This is considered a meaningful change in functional recovery after stroke.
Time frame: 4 weeks
The frequency, type, severity, and relationship to treatment of all adverse events (AEs) occurring during the 4-week intervention period. Adverse events include local reactions (e.g., pain, bruising, bleeding), systemic symptoms (e.g., dizziness, fatigue), and serious adverse events (SAEs) as per ICH-GCP criteria. Events will be assessed and documented by blinded evaluators using a standardized adverse event reporting form.
Time frame: 4 weeks
Patient self-reported global impression of overall improvement, rated using a 7-point Likert scale ranging from "Very much worse" to "Very much improved," collected at the end of the 4-week treatment period. This scale reflects the patient's perception of treatment benefit and subjective functional change.
Contact information is provided by the study sponsor or research team.
Dr Nguyen Ngo Le Minh Anh MD, PhD
Other
Effectiveness of Xingnao Kaiqiao Acupuncture Compared to Electroacupuncture in Improving Upper Limb Function in Early Stroke Rehabilitation: A Randomized Controlled Trial
Acronym: XNKQ-RCT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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