Limb Dysfunction in Ischemic Stroke Patients at High-Altitude Regions
Conditions
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.
Interventions
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.
DEVICESham electroacupuncture intervention
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.
Sponsors
Qinghai People's Hospital
Kaiyang Zheng
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fugl-Meyer Assessment Scale (FMA) | Baseline，Day 7，Day 14 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Activities of Daily Living Assessment Scale (ADL) Score | 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. |
Contacts
Primary Contactkaiyang zheng
Outcome results
None listed