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

NCT07078175 | Recruiting

• 1 other identifier: XNKQ-StrokeRCT2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-stroke

Keywords

acupuncture; Xingnao Kaiqiao; Stroke Rehabilitation; Motor Recovery; Traditional Medicine

Outcome Measures

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.

  4 weeks

Secondary Outcomes (3)

• Change in Barthel Index Score

  4 weeks

• Proportion of Participants Achieving MCID in FMA-UE

  4 weeks

• Proportion of Participants Achieving MCID in Barthel Index

  4 weeks

Other Outcomes (2)

• Incidence and Classification of Adverse Events

  4 weeks

• Patient Global Impression of Change (PGIC)

  4 weeks

Study Arms (2)

Xingnao Kaiqiao Acupuncture

EXPERIMENTAL

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.

Procedure: Xingnao Kaiqiao Acupuncture

Electroacupuncture

ACTIVE COMPARATOR

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.

Procedure: Electroacupuncture

Interventions

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

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.

Electroacupuncture

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr Nguyen Ngo Le Minh Anh MD, PhD: lead

Study Sites (1)

Ho Chi Minh City Orthopedic and Rehabilitation Hospital

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

RECRUITING

MeSH Terms

Interventions

Electroacupuncture

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Minh-Anh Nguyen Ngo Le, M.D., Ph.D.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

0084-962644648; drminhanh@ump.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer, MD, PhD- Faculty of Traditional Medicine, University of Medicine and Pharmacy at Ho Chi Minh City

Model Details: 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

Study Record Dates

• First Submitted: July 13, 2025
• First Posted: July 22, 2025
• Study Start: November 1, 2024
• Primary Completion: July 20, 2025
• Study Completion: August 1, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-01

Locations

VN (1)