NCT01444794已完成不适用
A National, 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 Lower Limb Spasticity Following Stroke
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
- 100
- 试验地点
- 24
- 主要终点
- Responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale (GAS).
研究概览
简要总结
The purpose of the protocol is to assess the responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale following one botulinum toxin type-A (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
- •Suffering from lower limb spasticity following stroke
- •With at least a 12-week interval between the last BoNT-A injection and inclusion
- •Decision already been agreed to inject BoNT-A
排除标准
- •Documented positive antigenicity to botulinum toxin
- •Any neuromuscular junction indication
- •Severe muscle atrophy in any muscle to be injected
- •Any other indication that might interfere with rehabilitation or the evaluation of results
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).
时间窗: Between 1 and 3 months from inclusion
Assessed using the Goal Attainment Scale (GAS).
次要结局
- Global assessment of benefits by both the investigator and the subject (or guardian).(Up to 5 months)
- Overall attainment of treatment goals(Between 1 and 3 months from inclusion)
- The use of standardized outcome measures and their results (e.g. muscle tone reduction, pain scores, functional tests).(Up to 5 months)
- Description of injection practices (BoNT-A: doses, volume, injection points, electromyography, electrostimulation and ecography).(Up to 5 months)
研究者
研究点 (24)
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