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Completed

NCT Number: NCT07078175

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

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.

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Key information

Conditions

Post-stroke

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ho Chi Minh City Orthopedic and Rehabilitation Hospital

Ho Chi Minh City, Ho Chi Minh, 700000, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xingnao Kaiqiao Acupuncture

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

Procedure

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

Primary outcomes

  1. Change in Fugl-Meyer Assessment of Upper Extremity (FMA-UE) Score

    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.

Secondary outcomes

  1. Change in Barthel Index Score

    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

  2. Proportion of Participants Achieving MCID in FMA-UE

    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.

  3. Proportion of Participants Achieving MCID in Barthel Index

    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.

Other outcomes

  1. Incidence and Classification of Adverse Events

    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.

  2. Patient Global Impression of Change (PGIC)

    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.

Sponsors and collaborators

Lead sponsor

Dr Nguyen Ngo Le Minh Anh MD, PhD

Other

Registry information

Official study title

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

Acronym: XNKQ-RCT

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 22, 2025
Registry last updated
Aug 26, 2026

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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