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

Kaiyang Zheng

Status: Not yet enrolling

Conditions: Limb Dysfunction in Ischemic Stroke Patients at High-Altitude Regions

Treatments: Device: Sham electroacupuncture intervention; Device: Electroacupuncture Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07074600

PJ202501-23

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Electroacupuncture Therapy

Experimental group

Description:

Participants will be randomized into an experimental group and a control group. The experimental group will receive daily electroacupuncture therapy for a standardized 14-day course, with comprehensive functional and neurological assessments conducted at pre-intervention (baseline) and post-intervention timepoints. The control group will undergo daily sham acupuncture under identical conditions, including matching treatment duration and assessment schedules. Electroacupuncture administration will target acupoints spanning cranial, upper limb, and lower limb anatomical domains.

Treatment:

Device: Electroacupuncture Therapy

Sham electroacupuncture intervention

Experimental group

Description:

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.

Treatment:

Device: Sham electroacupuncture intervention