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

NCT07074600 | Not Yet Recruiting

• 1 other identifier: PJ202501-23
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Limb Dysfunction in Ischemic Stroke Patients at High-Altitude Regions

Outcome Measures

Primary Outcomes (2)

• Fugl-Meyer Assessment Scale (FMA)

  "Baseline"，"Day 7"，"Day 14"

• Fugl-Meyer Assessment Scale (FMA)

  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.

  "Baseline"，"Day 7"，"Day 14"

Secondary Outcomes (1)

• Activities of Daily Living Assessment Scale (ADL) Score

  "Baseline"，"Day 7"，"Day 14"

Study Arms (2)

Electroacupuncture Therapy

EXPERIMENTAL

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.

Device: Electroacupuncture Therapy

Sham electroacupuncture intervention

EXPERIMENTAL

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.

Device: Sham electroacupuncture intervention

Interventions

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.

Also known as: Electroacupuncture

Electroacupuncture Therapy

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.

Also known as: Sham electroacupuncture

Sham electroacupuncture intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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 .

You may not qualify if:

• (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.

Sponsors & Collaborators

• Kaiyang Zheng: lead
• Qinghai People's Hospital: collaborator

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

Central Study Contacts

kaiyang zheng

CONTACT

15079603010; zky20000623@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: student

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 20, 2025
• Study Start: August 15, 2025
• Primary Completion: January 15, 2026
• Study Completion: February 15, 2026
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share