此页面是自动翻译的，不保证翻译的准确性。请参阅英文版对于源文本。

Study to Document the Effectiveness of Dysport in Patients Suffering From Upper Limb Spasticity (ULS) After Stroke (PSAS REGISTRY)

2018年12月20日更新者：Ipsen

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

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.

研究概览

地位

完全的

条件

Post Stroke Arm Spasticity

研究类型

观察性的

注册 (实际的)

108

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

波兰
- - Ciecierzyn、波兰、21-003
    - Indywidualna Praktyka Lekarska
  - Katowice、波兰、40-752, ul Medyków 14
    - Samodzielny Publiczny Centralny Szpital Kliniczny im, Śląskiego Uniwersytetu Medycznego w Katowicach Oddział Neurologii Wieku Podeszłego
  - Sandomierz、波兰、27-600 Schinzla 13
    - Samodzielny Publiczny Zespół Zakładów Opieki Zdrowotnej w Sandomierzu - Szpital - Oddział Neurologii z Pododdziałem Udarowym
  - Szczecin、波兰、Chopina 22, 71-450
    - Indywidualna Specjalistyczna Praktyka Lekarska W Zakresie Neurologii
  - Warsaw、波兰、Sobieskiego 9, 02-957
    - II Klinika Neurologiczna, Instytut Psychiatrii i Neurologii
  - Wrocław、波兰、51-149 KOSZAROWA 5
    - Wojewódzki Szpital Specjalistyczny Im.J.Gromkowskiego

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients suffering from post-stroke arm spasticity and scheduled to receive injection of Dysport in post stroke upper limb spasticity drug programme.

描述

Inclusion Criteria:

≥ 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.

Exclusion Criteria:

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).

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Change in Investigator and patient Clinical Global Impression of Improvement (CGI-I) 大体时间：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.	Change from baseline (visit 1) to visit 3 (visits occur every 3-4 months, during approximately 9 months of observation)

次要结果测量

结果测量	措施说明	大体时间
Global assessment of spasticity by Modified Ashworth Scale (MAS) 大体时间：Visits 1, 2 and 3 (visits occur every 3-4 months, during approximately 9 months of observation)	MAS - spasticity scores at each joint: shoulder, elbow, wrist, finger, thumb	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 大体时间：Visits 1, 2 and 3 (visits occur every 3-4 months, during approximately 9 months of observation)		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 大体时间：Visits 1, 2 and 3 (visits occur every 3-4 months, during approximately 9 months of observation)	Direct costs associated with the administration of Dysport will include the dose of Dysport, interval between reinjections, cost of healthcare resources: needles, syringes, identification techniques of the muscles.	Visits 1, 2 and 3 (visits occur every 3-4 months, during approximately 9 months of observation)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Ipsen

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年3月1日

初级完成 (实际的)

2016年9月1日

研究完成 (实际的)

2016年9月1日

研究注册日期

首次提交

2015年4月28日

首先提交符合 QC 标准的

2015年5月11日

首次发布 (估计)

2015年5月14日

研究记录更新

最后更新发布 (实际的)

2018年12月21日

上次提交的符合 QC 标准的更新

2018年12月20日

最后验证

2018年12月1日