Prognostic Value for Predicting Outcome Using Functional Near-infrared Spectroscopy in Stroke Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Change of Outcome Prediction Rate
研究概览
简要总结
To investigate the prognostic value of Functional Near-Infrared Spectroscopy (fNIRS) in stroke rehabilitation with serial measurements.
详细描述
Serial measurements (immediately after being transferred to rehabilitation department [T0], at discharge from inpatient rehabilitation [T1], and follow up at one to three months from stroke onset [T3]) using Functional Near-Infrared Spectroscopy (fNIRS) was done in all participants. The primary outcome was the outcome prediction rate using fNIRS parameter and clinical parameters. Secondary outcomes were as follows: fNIRS activation pattern, Laterality Index, Functional Connectivity, Fugl-Meyer Score, Modified Barthel Index, , Brunnstrom Stage, Box and Block Test, Grip Strength (handgrip, pinch grip, lateral prehension, three-jaw chuck), Modified Ashworth Scale (wrist flexor and extensor spasticity, elbow flexor, and extensor spasticity, long finger flexor spasticity), modified Rankin Scale score, Functional Ambulation Category, Glasgow Coma Scale, Neglect Evaluation Battery, Korean Version Western Aphasia Battery, and Scale for the Assessment and Rating of Ataxia.
The changes in the fNIRS measurements and clinical parameters will be analyzed and also the correlation between the two will be analyzed to identify the prognostic value of fNIRS.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 是
入选标准
- •Age 18 or above.
- •Diagnosed as stroke (infarction/hemorrhage) with imaging studies.
- •Participants who have given consent after listening to the full explanations of this study.
- •Able to understand the contents of this study and is able to sign to the written consent by his/herself.
- •A legal representative has given written consent for those who meet the inclusion criteria but is unable to understand and agree by themselves due to impaired cognition, a legal representative.
排除标准
- •Traumatic brain injury.
- •Unable to perform simple commands (motor task during fNIRS scan) due to impaired cognition.
- •Current symptoms are caused by diseases other than stroke (e.g., dementia, Parkinson's disease)
- •Participants with any symptoms that may hinder the compliance or evaluation (e.g., delirium and agitation) process.
- •Participants with any uncontrolled disorders.
结局指标
主要结局
Change of Outcome Prediction Rate
时间窗: After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
Outcome prediction rate using fNIRS parameter and clinical parameters.
次要结局
- Change of Scale for the Assessment and Rating of Ataxia (SARA)(After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2))
- Change of Box and Block Test Score(After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2))
- Change of Functional Ambulatory Category (FAC) Score(After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2))
- Change of Glasgow Coma Scale (GCS) Score(After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2))
- Change of Grip strength(After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2))
- Change of fNIRS activation pattern(After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2))
- Change of Laterality Index(After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2))
- Change of Modified Barthel Index (MBI) Score(After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2))
- Change of National Institutes of Health Stroke Scale (NIHSS) Score(After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2))
- Change of Modified Rankin Scale (mRS) Score(After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2))
- Change of Neglect Evaluation Battery Score(After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2))
- Fugl-Meyer Assessment (FMA) Scale(After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2))
- Change of Brunnstrom Stage Score(After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2))
- Change of Modified Ashworth Scale Score(After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2))
- Change of Western Aphasia Battery (WAB)(After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2))
研究者
Nam-Jong Paik
Professor
Seoul National University Bundang Hospital