NCT02275312已完成不适用
ETREAT: A Prospective Observational Study to Evaluate the Effectiveness of Botulinum Toxin Type A (BoNT-A) Injections in Patients With Post-stroke Upper and/or Lower Limb Spasticity in the Early Stage of Spasticity Development.
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
- 110
- 主要终点
- Change in Goal Attainment Scale (GAS) score.
研究概览
简要总结
The objective of this study is to evaluate the effectiveness of BoNT-A on functional improvement in patients with post-stroke upper and/or lower limb spasticity in the early stage of spasticity development, according to routine clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women ≥ 18-80 years.
- •Poststroke limb spasticity.
- •Patients who have suffered a stroke in the previous 6 months.
- •Treatment goal has been previously agreed with the patient or their legal representative.
- •Patients with clinically significant poststroke upper/lower limb spasticity, in whom it has been decided to perform multidisciplinary treatment with BoNT-A + rehabilitation.
- •No previous treatment with BoNT-A.
- •Patient is able to follow the protocol.
- •Written informed consent.
排除标准
- •Neuromuscular disease.
- •Use of drugs that interfere with neuromuscular transmission.
- •Any other condition that could interfere with rehabilitation or evaluation of the results.
- •Diagnosis of spasticity not associated with stroke.
- •Pregnant or nursing mothers.
- •Prior participation in any other study in the 6 months before study entry
结局指标
主要结局
Change in Goal Attainment Scale (GAS) score.
时间窗: Baseline, 16 months
次要结局
- Change in Modified Ashworth Scale (MAS) score.(Baseline, 16 months)
- Change on EQ-5D quality of life questionnaire(Baseline, 16 months)
- Time interval between injections(From baseline up to 16 months)
- Change in pain according to Visual Analog Scale (VAS).(Baseline, 16 months)
- Cost per patient(From baseline up to 16 months)
- Spasticity patterns will be defined in patients with upper and/or lower limb spasticity in the early stage after stroke(Baseline, 16 months)
- Baseline characteristics of patients(Baseline)
- Percentage of patients reporting functional improvement evaluated by Goal Attainment Scale (GAS) score.(From baseline up to 16 months)
- Passive function of upper and/or lower limbs according to primary treatment target (PTT) from the disability assessment scale (DAS).(Baseline, 16 months)
- Comfortable barefoot walking speed, measured with the 10-meter walking speed test.(Baseline, 16 months)
- Estimation of use of healthcare resources and costs associated with management of spasticity.(From baseline up to 16 months)
研究者
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