NCT00651690已完成2 期
Study of Responsiveness of Seven Functional Tasks in Patients With Poststroke Upper Limb Spasticity With Botulinum Toxin Type A Treatment
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Seven functional tasks (nail filing, hand cleaning, holding a water bottle, brushing teeth, holding a small fruit, holding a medium fruit, and holding a large fruit)
研究概览
简要总结
This study evaluates the responsiveness of 7 functional tasks to botulinum toxin Type A treatment in poststroke patients with spasticity of the upper-limb flexors
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Medically stable poststroke with focal unilateral upper-limb spasticity
排除标准
- •Stroke within 6 months of the study enrollment visit
- •Previous or current botulinum toxin therapy of any type in the study limb
结局指标
主要结局
Seven functional tasks (nail filing, hand cleaning, holding a water bottle, brushing teeth, holding a small fruit, holding a medium fruit, and holding a large fruit)
时间窗: Week 6
次要结局
- Spasticity of the upper-limb flexors as measured by the Ashworth Scale(Week 6)
研究者
研究点 (1)
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