A Longitudinal Study of Function and Participation in Patients With Stroke: An Integrated Brain Imaging and Biomechanical Analysis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change from baseline of biomechanical measurement for Healthy adult and patients with stroke in 6 months and 12 months
研究概览
简要总结
A longitudinal study of function and participation in patients with stroke: An integrated brain imaging and biomechanical analysis
详细描述
Brain damage may lead to various motor deficits, which further influence the function and participation. Cerebral vascular accident (CVA) is the common disorder for acquired brain damage. Neural network in patients with brain damage could also be used to determine their clinical behavior by identifying altered neural network associated with behavioral improvement. The investigators hypothesize that the level of brain image and biomechanical will change with time in patients with stroke. Under this hypothesis, the measures of biomechanical change are correlated with neural changes. The aim of this study is to investigate the function and participation in patients with stroke evaluated by clinical measures, biomechanical, psychological, physiological and multimodal brain image. The primary goal of this study is to establish, evaluate and follow-up biomechanical- and image-based biomarkers for the impairment of function and participation information processing present in patients with stroke.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with stroke
- •Aged 20-80 years old
- •Both ischemic stroke and hemorrhage
排除标准
- •Contraindication to MRI, such as metallic implant
- •History of psychiatric disease
- •Received Botulinum toxin (BTX-A) injection or surgery in recent six months
- •Severe psychological impairments, such as mental retardation or severe Communication problems
- •Progressive disorders, such as neurodegenerative disease
- •Active medical disease, such as infection
结局指标
主要结局
Change from baseline of biomechanical measurement for Healthy adult and patients with stroke in 6 months and 12 months
时间窗: baseline, 6 months, 12 months
Muscle tone, Muscle strength and Kinematic analysis for upper limb and gait analysis
次要结局
- Change from baseline of activity in 6 months and 12 months(baseline, 6 months, 12 months)
- Change from baseline of participation in 6 months and 12 months(baseline, 6 months, 12 months)
- Change from baseline of quality of life in 6 months and 12 months(baseline, 6 months, 12 months)
- Change from baseline of functional magnetic resonance imaging (fMRI) analysis in 6 months and 12 months(baseline, 6 months, 12 months)
- Change from baseline of body composition in 6 months and 12 months(baseline, 6 months, 12 months)
- Change from baseline of psychological in 6 months and 12 months(baseline, 6 months, 12 months)
- Change from baseline of severity in 6 months and 12 months(baseline, 6 months, 12 months)
- Change from baseline of body in 6 months and 12 months(baseline, 6 months, 12 months)