Psychometric Validation Study of the Spasticity Quality of Life 6-Dimensions (SQOL-6D) in Upper-limb Spasticity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 104
- 试验地点
- 16
- 主要终点
- Validation of SQOL-6D in upper limb spasticity
研究概览
简要总结
The purpose of the study is to describe the psychometric properties (validity, reliability and responsiveness) of the SQOL-6D instrument in the context of routine clinical treatment of upper limb spasticity.
详细描述
The study qualifies as interventional not because of the use of an investigational product, but because the imposed specific data collection procedures include multiple questionnaire assessments and one on-site visit not necessarily part of routine clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Currently resident in the UK
- •Subjects with a diagnosis of ULS
- •Receiving a treatment at the enrolment visit, as part of their routine clinical management, aiming at reducing spasticity
- •Sufficient grasp of English and cognitive ability to be able to understand the SQOL-6D questions, give informed consent and complete the protocol requirements as judged by the investigator
排除标准
- •The subject has already been included in the study
- •The subject, in the opinion of the investigator, would be unable to understand the questionnaire or to comply with the requirements of the study
研究组 & 干预措施
Data collection
An electronic data capture (EDC) system will be used to collect data in electronic format. Data will be collected at the enrolment visit, at the follow-up visit (8 weeks +/-2 weeks) and 1 to 4 days after the follow-up visit.
干预措施: Data collection (Other)
结局指标
主要结局
Validation of SQOL-6D in upper limb spasticity
时间窗: Change from baseline (day 1) to 8 weeks +/-2 weeks (follow up visit)
Validity - Reliability - Responsiveness
次要结局
- EQ-5D-5L (EuroQoL 5 Dimensions, 5 Levels)(Day 1 and then 8 weeks +/-2)
- Neurological Impairment Scale adapted for ULS (ULS-NIS)(Day 1)
- Modified Ashworth Scale (MAS)(Day 1 and then 8 weeks +/-2)
- Gaseous (Goal Attainment Scaling Evaluation of Outcome for Upper-Limb Spasticity)(Day 1 and then 8 weeks +/-2)
- ArmA (Arm Activity Measure) Scores(Day 1 and then 8 weeks +/-2)
- Global assessment of benefit(8 weeks +/-2)