Interdisziplinäre Plattform für Rehabilitationsforschung Und Innovative Versorgung Von SchlaganfallpatientInnen - ImPRoVe Interdisciplinary Platform for Rehabilitation Research and Innovative Care of Stroke Patients - ImPRoVe
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 227
- 试验地点
- 6
- 主要终点
- Compound score
研究概览
简要总结
Observational study of functional recovery of stroke patients after discharge from rehabilitation
详细描述
Cerebrovascular diseases, such as stroke, are among the greatest challenges in healthcare. This proves the importance of neuro-rehabilitative research. Stroke research is often focused on the acute treatment phase as well as the inpatient rehabilitation. A remaining question is how do stroke patients clinically develop after being discharged from the hospital? How stable are the achieved rehabilitation effects and how much more clinical improvement is seen in the following time period, especially with regard to ICF functionality? In this observational longitudinal study, the current practice of neurorehabilitation will be investigated and the influence of motor skills, cognition, care situation, depression, information and fatigue on functional recovery as well as participation, autonomy and quality of life will be evaluated. Stroke patients will be examined at the end of rehabilitation, after three, six and 12 months. In addition, a group of chronic patients undergoes the same examinations and thereby represents a comparison group.
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
- •Ischemic or haemorrhagic stroke according to ICD 10 I61-I69
- •Patients in or after completion of rehabilitation phases C and D according to BAR criteria
- •Age >= 18
- •Sufficient knowledge of German
- •Existing declaration of consent
- •Deficit still existing (Rankin score of at least 1 at inclusion)
排除标准
- •need for care prior stroke
- •SAB, craniocerebral trauma, TIA as primary diagnosis
- •Severe pre-existing psychiatric disease
- •Participation in follow-up examination not possible
结局指标
主要结局
Compound score
时间窗: 12 months after discharge from rehabilitation
Compound outcome-parameter for functional recovery (from upper limb motor scores, e.g. Fugl-Meyer assessment, grip force, nine-hole peg test).
次要结局
- Index for measuring restrictions on participation (IMET)(3, 6 and 12 months after discharge from rehabilitation)
- Nine hole peg test (NHPT)(3, 6 and 12 months after discharge from rehabilitation)
- Patient reported health status (EQ-5D)(3, 6 and 12 months after discharge from rehabilitation)
- Aphasia test(3, 6 and 12 months after discharge from rehabilitation)
- Knowledge and information needs(3, 6 and 12 months after discharge from rehabilitation)
- National institutes of health stroke scale (NIHSS)(3, 6 and 12 months after discharge from rehabilitation)
- Patient Health Questionnaire (PHQ-9)(3, 6 and 12 months after discharge from rehabilitation)
- Apraxia screen of TULIA (AST)(3, 6 and 12 months after discharge from rehabilitation)
- Autonomy and participation(3, 6 and 12 months after discharge from rehabilitation)
- Fatigue scale for motor function and cognition (FSMC)(3, 6 and 12 months after discharge from rehabilitation)
- Line bisection test (LBS)(3, 6 and 12 months after discharge from rehabilitation)
- Grip and pinch force(3, 6 and 12 months after discharge from rehabilitation)
- Modified Rankin Scale (MRS)(3, 6 and 12 months after discharge from rehabilitation)
- Stroke impact scale (SIS)(3, 6 and 12 months after discharge from rehabilitation)
- Fugl-Meyer assessment upper extremity (FMA)(3, 6 and 12 months after discharge from rehabilitation)
- Time up and go test (TUG)(3, 6 and 12 months after discharge from rehabilitation)
- Montreal cognitive assessment (MoCA)(3, 6 and 12 months after discharge from rehabilitation)
- Return to work(3, 6 and 12 months after discharge from rehabilitation)