Post-stroke
Conditions
Keywords
acupuncture, Xingnao Kaiqiao, Stroke Rehabilitation, Motor Recovery, Traditional Medicine
Brief summary
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
PROCEDUREXingnao 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
PROCEDUREElectroacupuncture
Routine electroacupuncture using standard acupoints for hemiplegic upper limb rehabilitation, including LI15, LI11, SJ5, and LI4, with low-frequency electrical stimulation.
Sponsors
Dr Nguyen Ngo Le Minh Anh MD, PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fugl-Meyer Assessment of Upper Extremity (FMA-UE) Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Achieving MCID in FMA-UE | 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. |
| Proportion of Participants Achieving MCID in Barthel Index | 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. |
| Change in Barthel Index Score | 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 |
Countries
Vietnam
Contacts
PRINCIPAL_INVESTIGATORMinh-Anh Nguyen Ngo Le, M.D., Ph.D.
University of Medicine and Pharmacy at Ho Chi Minh City, Viet Nam
Outcome results
None listed