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

ConditionPost-stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorDr Nguyen Ngo Le Minh Anh MD, PhD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Xingnao Kaiqiao Acupuncture

    Procedure/Surgery

    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/Surgery

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Xingnao Kaiqiao AcupunctureExperimental treatment 1 intervention
Group B: ElectroacupunctureActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

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

Secondary outcomes

1

Change in Barthel Index Score

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
2

Proportion of Participants Achieving MCID in FMA-UE

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
3

Proportion of Participants Achieving MCID in Barthel Index

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

Other outcomes

1

Incidence and Classification of Adverse Events

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
2

Patient Global Impression of Change (PGIC)

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.

Time frame
4 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dr Nguyen Ngo Le Minh Anh MD, PhD

Lead sponsor

University of Science Ho Chi Minh City

Sponsor institution

Source ClinicalTrials.gov
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