NCT05671705已完成不适用
Effect of Sarcopenia in Stroke Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- Change of Modified Rankin Scale
研究概览
简要总结
Primary research purpose:
-Prospective study to screen post stroke patients with sarcopenia and evaluate its effect on recovery
Secondary research purpose:
- To determine the degree of sarcopenia and correlation with poor functional prognosis of stroke in the stroke patient group.
- To determine the degree of sarcopenia and correlation with dixon MRI of thigh muscle
- To evaluate surface EMG (SEMG)-based signals and correlation with sarcopenia
- To determine the degree of sarcopenia and correlation with brain morphometric changes
详细描述
Patients with first-ever stroke will be enrolled and assessed for sarcopenia. The evaluation parameters will include standard sarcopenia parameters and also SEMG-based signals and imaging studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 65 years of age or older, stroke patients with first onset within 4 weeks
排除标准
- •Patients who have not been evaluated for sarcopenia
- •Patients with neuromuscular diseases other than stroke that may affect gait function
- •Patients unable to conduct clinical trials according to instructions
- •Patients with uncontrolled medical/surgical disease
- •Patients with metal substances in the body such as cardiac pacemakers, cochlear implants, etc.
- •Patients who have difficulty collecting blood
- •Patients who are difficult to follow up after 6 months of onset due to moving to another area
- •Patients who have Parkinson's disease, dementia, or have a history of neuromuscular diseases such as Guillain-Barré syndrome or myasthenia gravis
结局指标
主要结局
Change of Modified Rankin Scale
时间窗: 6 months from the first onset of the stroke
Functional Disability -\> The scale runs from 0-6, running from perfect health without symptoms(0) to death(6).
次要结局
- Hand grip strength(within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke)
- Functional Ambulation Category(within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke)
- Thigh Dixon MRI(within 4 weeks and 6 months from the first onset of the stroke)
- serum biomarkers for sarcopenia(within 4 weeks from the first onset of the stroke)
- quadriceps muscle strength(within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke)
- Muscle ultrasonography(within 4 weeks and 6 months from the first onset of the stroke)
- Digitalized SEMG signals(within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke)
- Fugl-Meyer motor scale(within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke)
- Berg balance scale(within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke)
- Brain MRI(within 4 weeks and 6 months from the first onset of the stroke)
研究者
Sun Im
MD., PhD.
The Catholic University of Korea
研究点 (2)
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