International, Multicentre, Observational, Prospective, Longitudinal Study to Assess the Effectiveness of AboBoNT-A Injections for Adult Lower Limb Spasticity in a Real Life Cohort (AboLiSh)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 438
- 试验地点
- 51
- 主要终点
- Subject centred Goal Attainment Scaling Leg T score (GASleg T)
研究概览
简要总结
The purpose of the protocol is to assess the longitudinal attainment of person-centered and function related goals of patients who receive AbobotulinumtoxinA (aboBoNT-A) injections for adult lower limb spasticity over a period of 16 months.
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
- •Adult male and female subjects ≥18 years of age
- •Primary diagnosis with unilateral adult lower limb nonprogressive spasticity.
- •Subject able to take more than five steps with or without assistance.
- •Decision to treat the lower limb with aboBoNT-A by the care provider made prior to, and independently from, the decision to enroll the subject in the observational study as per country label.
- •Previously untreated with BoNT-A (i.e. naïve to BoNT-A), or previously treated with a BoNT-A (i.e. non-naïve to BoNT-A). For those who were previously treated with BoNTA, they should have responded to BoNT-A treatment and at least 12 weeks should have elapsed from prior injection.
- •Signed informed consent prior to participation in the study.
排除标准
- •Prior history of nonresponsiveness to BoNT-A therapy
- •Previous treatment with BoNT-A of less than 12 weeks prior to enrolment in study.
- •Current participation in any other clinical study or have participated within the 12 weeks prior to the Inclusion visit (Visit 1) of this study.
- •Severe limitations in passive range of motion/contractures in the affected limb (MAS=4 in at least one of the joints in the lower limb).
- •Limb surgery or intrathecal baclofen therapy placement for spasticity within 3 months.
- •Nonambulatory subject.
- •Pregnant and lactating women.
- •Progressive neurological conditions or diagnosis of cerebral palsy.
结局指标
主要结局
Subject centred Goal Attainment Scaling Leg T score (GASleg T)
时间窗: 16 months
Mean individual GASleg T score. Goal attainment for each goal will be recorded clinically on a 5-point verbal rating scale (range -2 to +2) and goal scores combined to give an aggregated T score using a standard formula (GASleg T score). Range meaning is -2 = much less than expected and +2 = much more than expected. The subject and/or caregiver to identify the main goal areas and establish agreed person centred and function related goals guided by GASleg (usually one primary and up to two secondary goals) at each visit. Goal attainment will be evaluated at the routine follow up visit. Goals will be redefined and/or newly set at each injection visit or as per routine practice if further injections are not given. Goals will be SMART \[Specific, measurable, attainable, relevant, and time-based\]
次要结局
- Muscle tone(16 months)
- Assess correlations of subject centered goals(16 months)
- Total dose injected per cycle(16 months)
- Report dose per muscle(16 months)
- Severity of different aspects of impairment(16 months)
- Report muscles injected(16 months)
- Evolution of Quality of Life(16 months)