临床试验/NCT01020500

NCT01020500已完成不适用

An International, Prospective Cohort to Document the Effectiveness of One BoNT-A Injection Cycle Based on Attainment of Individual Person-centred Goals in Adult Subjects Suffering From Upper Limb Spasticity Following Stroke

Ipsen96 个研究点分布在 10 个国家目标入组 469 人开始时间: 2010年1月最近更新: 2020年11月6日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Ipsen
入组人数: 469
试验地点: 96
主要终点: Responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale (GAS) following one BoNT-A injection cycle in accordance with routine practices

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of the study is to assess the responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale following one BoNT-A injection cycle in accordance with routine practices.

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

•Upper limb spasticity following stroke
•At least a 12-week interval between the last injection (BoNT-A or BoNT-B) and inclusion
•Decision already been agreed to inject BoNT-A
•Agreement with the subject on goal setting

排除标准

•Contraindications to any BoNT-A preparations

结局指标

主要结局

Responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale (GAS) following one BoNT-A injection cycle in accordance with routine practices

时间窗: Around 3 to 5 months post injection

次要结局

Global assessment of benefits by both the investigator and the subject (or guardian)(Around 3 to 5 months post injection)
Overall attainment of the treatment goals using the GAS T score(Around 3 to 5 months post injection)
Result of standardized outcome measures (e.g., muscle tone reduction, pain scores, arm function test)(Around 3 to 5 months post injection)

研究者

发起方

Ipsen

申办方类型

Industry

责任方

Sponsor

研究点 (96)

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