Perceived Spasticity and Treatment Satisfaction Among Stroke Survivors Over the Course of a Complete Treatment Cycle With Botulinum Neurotoxin A (BoNT-A): an Ethnographic Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Severity of Pain
研究概览
简要总结
To investigate, through ethnography, changes in symptom burden and disability and their effects/interference on patient functioning, ability to perform activities of daily living (ADL) and quality of life (QoL) throughout the duration of one BoNT-A treatment cycle.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnostic of post-stroke spasticity more than three months prior to inclusion
- •At least 6 months on treatment (or two treatment cycles) with BoNT-A injections for spasticity according to the decision of the physician
- •Previous BoNT-A injection cycles did not last for more than 16 weeks
- •Ambulatory (use of walking aids is acceptable)
排除标准
- •Neurological disorder other than stroke
- •Spasticity-specific treatment changes within 3 months prior to inclusion
- •Patients who had undergone neurolysis or surgery to the affected limb within 6 months
- •Concurrent participation in a clinical trial for the treatment of spasticity
结局指标
主要结局
Severity of Pain
时间窗: 12 weeks
Severity of Pain as per EQ-5D-5L and a sliding scale. This is a descriptive scale that covers 5 dimensions: mobility, self-care, usual activities,pain/discomfort and anxiety/depression. the scale consist of 5 levels, where level one corresponds to "no problems" and level 5 corresponds to "extreme problem".
Degree of functional limitations in daily life activities
时间窗: monthly for 12 Weeks, or until end of injection cycle whichever occurs first
Degree of functional limitations in daily life activities (i.e. physical functioning) associated with post-stroke spasticity as assessed by using WHODAS parameters, and identification of their characteristics and changes over time
Health status in subjects with post-stroke spasticity
时间窗: weekly for 12 Weeks, or until end of injection cycle whichever occurs first
Health status in subjects with post-stroke spasticity as assessed by using EQ-5D-5L parameters, and identification of their characteristics and changes over time
次要结局
- Burden of spasticity/treatment(Opening interview and ending qualitative interviews, ethnography data which will be provided at discretion of patient/caregiver for 12 weeks or duration of treatment, whichever occurs first, may also support these qualitative analyses)
- Comparison of feedback between caregivers and stroke survivors(opening ( before week 1) and ending ( 2 weeks after end of injection cycle) qualitative interviews)
- Patients' satisfaction(weekly for 12 weeks or until end of injection cycle whichever occurs first. Opening and closing interview will also explore this)