NCT02444494
已完成
不适用
Observational Prospective Study to Document the Effectiveness of Dysport in Patients Suffering From Upper Limb Spasticity (ULS) After Stroke, Under Conditions of Routine Clinical Practice
概览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 108
- 试验地点
- 6
- 主要终点
- Change in Investigator and patient Clinical Global Impression of Improvement (CGI-I)
概览
简要总结
The objective of this non-interventional study is to evaluate clinical effectiveness and cost effectiveness of Dysport within the reimbursement scheme called "drug programme" funded by Polish National Health Fund (NHF) for patients with post stroke ULS. The study is designed to collect data in patients scheduled to receive Dysport treatment in a drug programme, based on routine treatment of subject with ULS.
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
- •≥ 18 years of age.
- •A history of ischemic or haemorrhagic stroke before minimum 3 months prior to the inclusion into drug programme, documented by discharge from the hospital.
- •Post-stroke spasticity of confirmed upper extremity moderate or higher (the result of the modified Ashworth scale - MAS ≥ 2) in at least one muscle group.
- •Classification of the patient into the programme occurs when a patient has a designated date of commencement of medical rehabilitation confirmed by the providing rehabilitation services.
- •Drug administration needs to take place no earlier than three weeks before the start of medical rehabilitation.
- •Written informed consent given by patient before any occurrence of study related procedure.
- •Patient has been already included in a NHF Dysport programme.
排除标准
- •Severe dysphagia and respiratory disorders.
- •Pregnancy
- •Myasthenia gravis and myasthenic syndrome - based on neurological examination (additional tests only in justified cases).
- •Generalized symptoms of infection
- •The presence of inflammation within the planned sites of administration.
- •Fixed contractures in the soft tissues and joints.
- •Dementia medium or deep cycle (score on mini mental state examination (MMSE) equal to or less than 18 points).
结局指标
主要结局
Change in Investigator and patient Clinical Global Impression of Improvement (CGI-I)
时间窗: Change from baseline (visit 1) to visit 3 (visits occur every 3-4 months, during approximately 9 months of observation)
Clinical Global Impression of Improvement (CGI-I) scale: 7-point scale, ranging from 1 (very much improved) to 7 (very much worse), with a score of 4 indicating no change.
次要结局
- Global assessment of spasticity by Modified Ashworth Scale (MAS)(Visits 1, 2 and 3 (visits occur every 3-4 months, during approximately 9 months of observation))
- Measurement of upper limb muscle weakness by Medical Research Council (modified MRC) scale for muscle strength(Visits 1, 2 and 3 (visits occur every 3-4 months, during approximately 9 months of observation))
- To document cost of treatment with Dysport in these patients(Visits 1, 2 and 3 (visits occur every 3-4 months, during approximately 9 months of observation))
研究者
研究点 (6)
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