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临床试验/NCT02982278
NCT02982278已完成不适用

Wide Spectrum Investigation of Stroke Outcome Disparities on Multiple Levels (WISSDOM): Community-based Intervention Under Nurse Guidance

Medical University of South Carolina2 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
87
试验地点
2
主要终点
Stroke Specific Quality of Life Scale

研究概览

简要总结

This research project will evaluate the relationship between cardiovascular risk factors, degrees of physical and mental activity prior to the stroke, brain tissue integrity, post-stroke community participation and neurological recovery after the stroke. Investigators will recruit and study healthy and post stroke participants, gaining insight into the possible mechanisms that explain why the adverse risk profile, which is more commonly present in African-Americans than non-Hispanic Whites in the stroke belt, is translated into a less favorable recovery post stroke.

详细描述

Stroke is a common cause of disability, but not all subjects who survive a stroke are left with debilitating sequelae. The human brain is able to self-repair and adapt after injury through neuroplasticity, which is crucial for stroke recovery. At present, recovery cannot be completely predicted from clinical stroke variables. A promising theory suggests that the health status of the stroke host is as important as stroke severity for recovery. Within the neurological system, health is reflected by the integrity of the brain tissue and its neuronal environment, which provide the neuroplastic potential that is necessary for recovery. The potential for neuroplasticity is likely variable across individuals and possibly accounts for some of the differences in outcome that cannot be explained by other clinical factors.

A better understanding of the relationship between stroke outcomes, host brain tissue integrity and recovery environment would have immense potential to address stroke related disabilities. The investigators are experts in research involving brain tissue integrity using neuroimaging and recovery environment using community based participation approaches involving nurse-guided community health workers (CHWs).

This research project will evaluate the relationship between cardiovascular risk factors, degrees of physical and mental activity prior to the stroke, brain tissue integrity, post-stroke community participation and neurological recovery after the stroke. The investigators will recruit and study a biracial cohort, gaining insight into the possible mechanisms that explain why the adverse risk profile, which is more commonly present in African-Americans than non-Hispanic Whites in the stroke belt, is translated into a less favorable recovery post stroke. If a better understanding of the underlying reasons for this observation can be defined, an important first step toward eliminating this disparity can be achieved.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 40-75 years
  • prestroke mRS score >2
  • African American or White
  • Reside in Berkeley, Charleston, Dorchester, Colleton or Georgetown Counties
  • Ischemic stroke involving only one hemisphere
  • Fugl Meyer score >16 at baseline or Aphasia Quotient in Western Aphasia Battery <93
  • no contraindications to research MRI

排除标准

  • Primary or secondary intracerebral hematoma, or subarachnoid hemorrhage, or subdural/ epidural hematoma; Prisoner; diagnoses of substance addiction (alcohol or illicit drugs)
  • Bihemispheric acute ischemic strokes;
  • Other concomitant neurological disorders, such as brain tumor, abscess or spinal cord disease affecting language or limb motor function;
  • Documented history of dementia prior to index event;
  • Patient suffered one or more recurrent stroke during the 12-month follow up period.
  • Terminal illness with life expectancy ≤ 1 year
  • Currently pregnant
  • Brain stem strokes

结局指标

主要结局

Stroke Specific Quality of Life Scale

时间窗: 3, 6, 12 months

Quality of Life

NIH Stroke Scale

时间窗: 0, 3, months

Stroke Severity

Stroke Impact Scale

时间窗: 3, 6, 12 months

Stroke recovery

次要结局

  • Patient Health Questionnaire-9(3, 6 12 months)
  • Medical Outcomes Study Social Support Scale(3, 6, 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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