Investigation of Clinical, Blood, and Neuroimaging Biomarkers as Predictors of Independent Walking Post-Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Change in Functional Ambulation Category
研究概览
简要总结
Prediction of walking recovery after stroke can inform patient-centered care and support discharge planning. The accuracy of current prediction models is limited, however, due to small study designs and narrow predictors assessed. The investigators propose a comprehensive evaluation of a novel combination of biomarkers to improve prediction of walking recovery and guide rehabilitation efforts after stroke. These include acute structural brain network disruption (utilizing MRI); blood biomarker levels (e.g., brain-derived neurotrophic factor and vascular endothelial growth factor); and clinical assessments of strength and mobility. The overall study objectives are to assess protocol feasibility and investigate relationships between select biomarkers and walking recovery to provide strong justification for a larger study on predictors of independent walking after stroke. The proposed objectives will be pursued through the following specific aims: 1) Assess feasibility of a larger study and develop methods for telehealth data collection; 2) Establish baseline levels of biomarkers and average change over time; and 3) Elucidate relationships between baseline levels of biomarkers and walking gains across time in persons after stroke. A longitudinal, observational study design will be utilized for this study. Thirty-five persons with acute (≤7 days) stroke will be recruited from the local medical center. Select inclusion criteria include presence of new lower limb weakness and assistance for walking; select exclusion criteria include cerebellar stroke or other neurological disorders such as Parkinson's Disease. Subjects will undergo clinical evaluation at week 1, 4, 9, 12, and 26 weeks post-stroke. MRI scans will occur within 12 days post-stroke and at 12 weeks post-stroke, and blood draws within 1 week, 1 to 2 weeks and at 12 weeks post-stroke. To assess feasibility the investigators will examine study processes, recruitment, resources, study management, and scientific assessment. To examine the role of acute clinical, neuroimaging, and physiological measures in predicting walking recovery, the investigators will examine relationships between these measures and walking outcome at 12-weeks post-stroke. The proposed research is expected to provide strong scientific support for future clinical trials designed to target therapies based on predicted functional potential. Such knowledge has the potential of enhancing mobility gains and patient independence following stroke.
详细描述
The investigators will utilize a longitudinal, observational study design to investigate predictors of walking recovery post-stroke. Subjects will undergo clinical evaluation at week 1, 4, 9, 12, and 26 weeks after the initial onset of stroke symptoms; MRI scan within 12 days and at 12 weeks post-stroke; and blood draws at 1 week, 1 to 2 weeks and at 12 weeks post-stroke. Subjects will be recruited from the University of Vermont Medical Center (UVMMC), with a goal sample of 35 patients (accounts for 15% attrition). Subjects will provide written consent before participation.
Aim 1: Assess feasibility of a larger study and develop methods for telehealth data collection
Data Collection: To assess feasibility the investigators will examine study processes, recruitment, resources, study management, and scientific assessment.
Data Analyses: Feasibility questions will be examined using descriptive statistics and qualitative analyses. To ensure collection and dissemination of high quality data, the "CONSORT 2010 checklist of information to include when reporting a pilot or feasibility trial" will be used to guide data collection and analysis.
Aim 2: Establish baseline levels of biomarkers (clinical, neuroimaging, blood) and average change over time.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in Functional Ambulation Category
时间窗: week 1, week 4, week 9, week 12, and week 26 s/p stroke
Assessment of walking assistance
Change in blood markers - VEGF
时间窗: within week 1, at 1-2 weeks and at 12 weeks post-stroke
serum VEGF
Change in diffusion tensor imaging
时间窗: within 12 days and at 12 weeks post-stroke
fractional anisotropy and structural connectivity metrics
Change in blood markers - BDNF
时间窗: within week 1, at 1-2 weeks and at 12 weeks post-stroke
serum BDNF
次要结局
- Change in 3-meter walk test(week 1, week 4, week 9, week 12, and week 26 s/p stroke)
- Change in National Institutes of Health Stroke Scale(within 72 hours and 1 week post-stroke)
- Change in Barthel Index(week 12 and 26 s/p stroke)
- Change in Modified Rankin Scale(week 12 and 26 s/p stroke)
- Mini-Mental Status Exam(1 week post-stroke)
- Change in Trunk Control Test(week 1, week 4, week 9, week 12, and week 26 s/p stroke)
- Change in lower extremity muscle strength as assessed by Medical Research Council grades(week 1, week 4, week 9, week 12, and week 26 s/p stroke)
- Change in Berg Balance Scale(week 1, week 4, week 9, week 12, and week 26 s/p stroke)
- Change in Motricity Index (lower limb portion)(week 1 , week 4, week 9, week 12, and week 26 s/p stroke)
- Change in Modified 30 second sit to stand(week 1, week 4, week 9, week 12, and week 26 s/p stroke)
- Change in Fatigue Severity Scale(week 1, week 4, week 9, week 12, and week 26 s/p stroke)
- Change in physical activity levels as assessed by the Physical Activity Vital Sign questionnaire(week 12 and 26 post-stroke)
- Change in blood markers - IL-6(within week 1,at 1-2 weeks and at 12 weeks post-stroke)
- Change in blood markers - cGP(within 1 week, at 1-2 weeks and at 12 weeks post-stroke)
- Change in Opal sensor metric - gait(week 1, week 4, week 9, week 12, and week 26 s/p stroke)
- Change in Opal sensor metric - posture(week 1, week 4, week 9, week 12, and week 26 s/p stroke)
- Change in blood markers - IL-10(within week 1,at 1-2 weeks and at 12 weeks post-stroke)
- Change in blood markers - C reactive protein(within week 1 ,at 1-2 weeks and at 12 weeks post-stroke)
- Change in blood markers - TNFalpha(within week 1, at 1-2 weeks and at 12 weeks post-stroke)
- Change in blood markers - matrix metalloproteinase(within week 1, at 1-2 weeks and at 12 weeks post-stroke)
- Change in blood markers - insulin-like growth factor-1(within 1 week, at 1-2 weeks and at 12 weeks post-stroke)
研究者
Denise Peters
Assistant Professor
University of Vermont