Do Time-related Trajectories of Muscle Alterations Predict Gait Recovery in Acute Stroke Patients? A Study Protocol for Two Cohort Studies
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 6-minutes walking test
研究概览
简要总结
The aim of this study is to explore time-related trajectories of muscle alterations and inflammation in acute hospitalized stroke patients. Furthermore, the researchers want to gain insight in the predictive values of these time-related trajectories towards gait recovery in the acute stroke population.
详细描述
STUDY DESIGN:
Two longitudinal prospective cohort studies will be conducted in which non-ambulatory (cohort 1) and ambulatory (cohort 2) acute stroke patients will participate.
PATIENT RECRUITMENT:
The investigators aim to recruit 200 subjects (100/cohort). Patients will be recruited at the Neurology ward of the UZ Brussel.
PROCEDURE:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years)
- •Hospitalized at the Neurology ward of UZ Brussel
- •Diagnosed with first-ever stroke (as defined by the World Health Organisation)
- •Able to provide written or verbal informed consent
排除标准
- •Other neurological or orthopaedic problems leading to impaired gait
- •Severe deficits of communication, memory or understanding
结局指标
主要结局
6-minutes walking test
时间窗: Change over time between baseline (≤ 3 days post-stroke), discharge (anticipated average of 10 days post-stroke) and 3 months follow-up
The 6-minutes walking test (6MWT) will evaluate the walking endurance of the subjects in cohort 2. During this test we will measure the distance walked over a span of 6 minutes.
Functional Ambulation Categories
时间窗: Change over time between baseline (≤ 3 days post-stroke), discharge (anticipated average of 10 days post-stroke) and 3 months follow-up
The Functional Ambulation Categories (FAC) will be used to measure walking ability in patients assigned to cohort 1. The score ranges from 0-5, with a higher score reflecting towards a more independent walking ability.
次要结局
- Grip strength(Baseline (≤ 3 days post-stroke), 3 days after baseline assessment, discharge (anticipated average 10 days post-stroke), 3 months)
- Muscle architecture(Baseline (≤ 3 days post-stroke), 3 days after baseline assessment, discharge (anticipated average 10 days post-stroke), 3 months)
- Oxygen cost(Baseline (≤ 3 days post-stroke), discharge (anticipated average 10 days post-stroke), 3 months)
- Muscle strength(Baseline (≤ 3 days post-stroke), 3 days after baseline assessment, discharge (anticipated average 10 days post-stroke), 3 months)
- Muscle Mass(Baseline (≤ 3 days post-stroke), 3 days after baseline assessment, discharge (anticipated average 10 days post-stroke), 3 months)
- Short Physical Performance Battery(Baseline (≤ 3 days post-stroke), 3 days after baseline assessment, discharge (anticipated average 10 days post-stroke), 3 months)
- Muscle Tone(Baseline (≤ 3 days post-stroke), 3 days after baseline assessment, discharge (anticipated average 10 days post-stroke), 3 months)
- Rivermead Mobility Index(Baseline (≤ 3 days post-stroke), discharge (anticipated average 10 days post-stroke), 3 months)
- Gait speed(Baseline (≤ 3 days post-stroke), discharge (anticipated average 10 days post-stroke), 3 months)
- Muscle Fatigue(Baseline (≤ 3 days post-stroke), 3 days after baseline assessment, discharge (anticipated average 10 days post-stroke), 3 months)
- Circulating biomarkers(Baseline (≤ 3 days post-stroke), 3 days after baseline assessment, discharge (anticipated average 10 days post-stroke), 3 months)
- Fatigue Assessment Scale(Baseline (≤ 3 days post-stroke), 3 days after baseline assessment, discharge (anticipated average 10 days post-stroke), 3 months)
研究者
Lotte Cuypers
Doctoral Researcher
Vrije Universiteit Brussel