Personalized Neurorehabilitative Precision Medicine - From Data to Therapies
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Motor outcome of the upper extremity (UE) after acute stroke
研究概览
简要总结
Stroke is the most common neurological disease leaving one third dead and one third with permanent impairment despite best medical treatment. The aim of the present study is to investigate why patients differ in how they benefit from neurorehabilitation by collecting clinical, electrophysiological, imaging and laboratory data in the acute phase of stroke as well as later on during rehabilitation and after 90 days. Following a closed-loop approach the data is analyzed by a machine learning algorithm to create a personalized neurorehabilitation strategy.
详细描述
Clinical tests: Each subject will be assessed using the following tests:
National Institute of Health Stroke Scale (NIHSS): The NIHSS is part of the usual highly standardized stroke workup. It consists of 15 items which can be scored with 0 to 4 points maximum. It is used to measure stroke severity as well as impairment and to detect improvement or deterioration of the patient. A high score corresponds to a severe stroke.
FMA for UE and sensory system: The FMA for the UE and the sensory system describes the sensory-motor impairment of the arm after stroke. It consists of 66 items for the motor function of the UE and 24 items for the sensory function scored from 0 to 2. A high score corresponds to high function. It is not part of the usual stroke workup. The change of the FMA for UE after 90 days compared to the first score obtained on the stroke unit during the acute phase of the stroke event will serve as the primary endpoint of this study.
Shoulder abduction finger extension (SAFE) score: To calculate the SAFE score shoulder abduction and finger extension is measured using the classification of the British Medical Research Council (MRC). The MRC scale scores muscle strength from 0 (no movement) to 5 (normal power). The scores are added up producing a value from 0 to 10. A score of 5 or more predicts a good or excellent outcome after stroke affecting the UE. It is not part of the usual stroke workup.
Grip strength: The grip strength can be quantified using a dynamometer. The best out of three trials counts. It is not part of the usual stroke workup.
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
- 否
入选标准
- •Subject is 18 years or above.
- •Subject has an acute stroke affecting one UE (FMA less than 50).
- •Subject or understands the study and its procedures and gives informed consent.
- •If the subject is not able to give informed consent:
- •The assumed will of the patient is to be determined by the patient's provision (if existing), the health care proxy (if existing) and/or the moral concepts expressed by the patient to close relatives.
- •The legal representative gives informed consent because participation is the assumed will of the patient as assessed by the aforementioned points.
排除标准
- •Subject is less than 18 years old.
- •The subject does not have an acute stroke, or stroke does not affect the UE, or FMA >
- •Subject or legal representative cannot give informed consent.
- •Patient has an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head (excluding the mouth) that cannot be safely removed.
- •Subject has a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
- •There is any concern by the investigator regarding the safe participation of the subject in the study, or for any other reason the investigator considers the subject inappropriate for participation in the study.
- •Subject is pregnant.
结局指标
主要结局
Motor outcome of the upper extremity (UE) after acute stroke
时间窗: 90 days
Fugl-Meyer Assessment for the upper extremity (FMA-UE) in the acute phase compared to the result after 90 days.
次要结局
- Independency in daily life after acute stroke(90 days)
- Functional outcome of the UE after acute stroke(90 days)
- Qualitiy of life after acute stroke(90 days)