From Research to Clinical Practice. Applying an Algorithm for Prognosis of Upper Limb Paresis in Patients With Subacute Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Action Research Arm test
研究概览
简要总结
Aim study 1:Assess the accuracy of PREP2 when applied in a subacute rehabilitation setting.
Aim study 2: Prediction of real life UL use. Method: A prospective cohort study. Main outcome measure study 1: Action Research Arm Test (ARAT), measuring UL motor function.
Main outcome study 2: use ratio between affected and unaffected UL measured by accellerometer.
Secondary outcome measure: Fugl-Meyer Motor Assessment for UL (FM).
详细描述
Background Accurate prediction of recovery of UL function after stroke can lead to targeted rehabilitation. The Predict Recovery Potential (PREP2) algorithm combines individual prediction of UL function with recommendations for treatment. The PREP2 algorithm is based on clinical assessment of UL paresis combined with transcranial magnetic stimulation (TMS) to examine corticospinal tract integrity. For this PhD project the PREP2 is modified to be applicable in a rehabilitation setting and the initial assessment of PREP2, the SAFE score, is carried out at day 14.
Study 1 Aim: Assess the accuracy of PREP2 when applied in a subacute rehabilitation setting.
Hypothesis: PREP2 applied at day 14 post stroke accurately predicts UL function 3 months after stroke for a minimum of 75 % of the patients.
Method: A prospective cohort study. Setting and population: The study will take place at Hammel Neurorehabilitation Centre and University Research Clinic. Ninety patients will be included.
Inclusion criteria: First or recurrent ischemic or hemorrhagic stroke (diagnosis verified by CT or MR scan); New upper limp impairment; Less than 15 days post stroke; ≥ 18 years; Able to follow simple commands and cooperate with examinations Main outcome measure: Action Research Arm Test (ARAT), measuring UL motor function.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First or recurrent ischemic or hemorrhagic stroke (diagnosis verified by CT or MR scan)
- •New upper limp impairment; Less than 15 days post stroke
- •≥ 18 years
- •Able to follow simple commands and cooperate with examinations
排除标准
- •Subarachnoid hemorrhages
- •UL motor residuals from former stroke
- •Severe illness with life expectancy < 6 months
- •Place of residence more than 1½ hours drive away and not reachable for follow up assessments
- •Patients with contraindications for TMS are excluded from the TMS part of the study.
结局指标
主要结局
Action Research Arm test
时间窗: dec 2019
Upper limb function test
次要结局
- Accellerometry(dec 2019)
- Fugl Meyer Motor and sensory assesment(Dec 2019)