Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07074600

Clinical Efficacy of Electroacupuncture Therapy on Limb Dysfunction in Ischemic Stroke Patients at High-Altitude Regions: A Multi-center Randomized Double-blind Controlled Trial

The purpose of this clinical trial is to investigate the efficacy of electroacupuncture therapy for limb dysfunction in ischemic stroke patients residing at high-altitude regions. This study aims to address the following research questions: 1. Whether electroacupuncture therapy demonstrates clinical effectiveness in managing limb dysfunction among ischemic stroke patients in high-altitude regions. 2. Whether electroacupuncture therapy maintains an acceptable safety profile in this specific population.

Researchers will conduct a comparative analysis between the active electroacupuncture intervention group and a sham-electroacupuncture control group to evaluate therapeutic efficacy. Participants will: 1. Undergo daily electroacupuncture treatment sessions for a standardized 14-day therapeutic course. 2. Complete comprehensive functional assessments and neurological evaluations at baseline and post-intervention timepoints.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • (1) Meeting diagnostic criteria for ischemic stroke ; (2) Aged 18-75 years ; (3) Total stroke episodes < 3 ; (4) Current stroke with disease course of 2 weeks to 3 months ; (5) Severity of limb motor impairment assessed by the National Institutes of Health Stroke Scale (NIHSS) score .

Exclusion criteria

  • (1) Patients with transient ischemic attack (TIA), cerebral hemorrhage, or reversible ischemic neurological deficit (RIND); (2) Patients with intracranial space-occupying lesions; (3) Patients with severe aphasia or other complications impairing scale assessment compliance; (4) Pregnant or lactating women, or those planning pregnancy; (5) Patients with acupuncture contraindications.

Treatment and study plan

Electroacupuncture Therapy

Device

Participants in the experimental group will receive daily electroacupuncture therapy over a standardized 14-day therapeutic course. Comprehensive functional and neurological assessments will be conducted at pre-intervention (baseline) and post-intervention timepoints. Acupoint selection will target anatomical domains spanning the cranial, upper limb, and lower limb regions.

Other names: Electroacupuncture

Sham electroacupuncture intervention

Device

Participants in the control group will receive daily sham electroacupuncture therapy over a standardized 14-day therapeutic course. Comprehensive functional and neurological assessments will be conducted at pre-intervention (baseline) and post-intervention timepoints. Sham electroacupuncture procedures will target non-acupoint locations outside recognized cranial, upper limb, and lower limb anatomical domains.

Other names: Sham electroacupuncture

Primary outcomes

  1. Fugl-Meyer Assessment Scale (FMA)

    Time frame: "Baseline","Day 7","Day 14"

  2. Fugl-Meyer Assessment Scale (FMA)

    Time frame: "Baseline","Day 7","Day 14"

    Assessments were conducted at baseline (pre-intervention), day 7 of treatment, and post-intervention. The evaluation comprises 33 items for upper extremity motor function and 17 items for lower extremity motor function. Each item is scored 2 points for full completion, 1 point for partial completion, and 0 points for inability to complete. The total score ranges from 0 to 66 for upper extremities and 0 to 34 for lower extremities, with higher scores indicating better motor function.

Secondary outcomes

  1. Activities of Daily Living Assessment Scale (ADL) Score

    Time frame: "Baseline","Day 7","Day 14"

    Assessments were conducted at baseline (pre-intervention), day 10 of treatment, and post-intervention. The ADL assessment scale is primarily used to evaluate the activities of daily living and functional status in stroke patients, encompassing 11 items related to 10 fundamental aspects of self-care and mobility. Each item is scored on a scale of 0 to 15 points, with the sum of all items constituting the ADL score. Higher scores indicate better daily living ability.

Study contacts

Contact information is provided by the study sponsor or research team.

kaiyang zheng

CONTACT

[email protected]

15079603010

Sponsors and collaborators

Lead sponsor

Kaiyang Zheng

Other

Collaborators

  • Qinghai People's Hospital

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 20, 2025
Registry last updated
Jul 20, 2025

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.