Investigation of Neurophysiological Substrates and Clinical Behaviour for Prognosis of Rehabilitation-induced Upper Limb Recovery After Stroke: Longitudinal Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Assessment
研究概览
简要总结
Clinical predictors of rehabilitation-induced arm recovery after stroke are still missing since literature provides evidence mainly on the spontaneous recovery path. This longitudinal cohort study aims to identify neurophysiological and behavioural features able to predict arm recovery and how it can change according to provided rehabilitation.
详细描述
Rationale: evidence suggests that integrity of the Cortico-Spinal Tract (CST), valid Motor Evoked Potentials (MEPs), age and neurological status are positive prognostic features for better recovery. Concurrently, dosage of rehabilitation therapy is a key factor in promoting functional recovery. However, there are no evidence suggesting whether dose of rehabilitation also influence prediction of UL motor recovery after stroke.
Aims: to define (i) predictive features for rehabilitation-induced UL recovery and (ii) the effect of rehabilitation doses.
Methods: stroke patients will be longitudinally enrolled and assessed with Magnetic Resonance Imaging, Transcranial Magnetic Stimulation (TMS), blood sample and clinical outcome measures at the beginning (T0) of rehabilitation and after 8 weeks (T1).
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
- •first ever single stroke
- •unilateral cortical/subcortical stroke
排除标准
- •other neurological disease
- •psychiatric disorders
- •cerebellar stroke
结局指标
主要结局
Fugl-Meyer Assessment
时间窗: Change from baseline up to 8 weeks.
Fugl-Meyer Upper Extremity is a stroke-specific scale which assesses the upper limb motor functioning in patients with post-stroke hemiplegia. There are 3 values: 0 (severe impairment), 1 (moderate impairment), 2 (preserved function). The minimum value is 0 points, which corresponds to upper limb hemiplegia. The maximum value is 66 points, which corresponds to normal motor performance.
次要结局
- Action Research Arm Test(Change from baseline up to 8 weeks.)
- Box & Blocks Test(Change from baseline up to 8 weeks.)
- Medical Research Council(Change from baseline up to 8 weeks.)
- Modified Ashworth Scale(Change from baseline up to 8 weeks)
- Presence of Motor Evoked Potentials(Change from baseline up to 8 weeks.)
- Reaching Performance Scale(Change from baseline up to 8 weeks.)
- Imaging data(Change from baseline up to 8 weeks.)
- Functional Independence Measure(Change from baseline up to 8 weeks)
研究者
Nicola Filippini
PHD, Psychologist
IRCCS San Camillo, Venezia, Italy