Gaitox :Therapeutic Benefit of Incobotulinum Toxin A for Spasticity of the Triceps Surae in Patients With Multiple Sclerosis an Observational Study on Gait Spatiotemporal Parameters
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 主要终点
- Spatiotemporal gait parameters
研究概览
简要总结
Introduction/Objectives: In this observational study, we assessed the benefit following an injection of 200 international units (IU) of incobotulinum toxinA in patients with multiple sclerosis (MS) with spasticity of the triceps surae (TS) at 6 weeks (peak efficacy of toxin) and at 3 months (cancellation of efficacy).
Methods: This study enrolled all MS patients willing to participate with Expanded Disability Status Scale (EDSS) scores of less than 6, who required toxin for management of focal spasticity of the TS. Treatment consisted of 200 IU of incobotulinum toxinA injected into the TS. Outcome measures were assessed before injection, at 6 weeks and 3 months post-injection, using the Goal Attainment Scale (GAS), Twelve Item MS Walking (MSWS-12) Scale, Timed Up and Go (TUG) Test, 6 Minute Walk Test (6MWT). Spatiotemporal gait data was obtained by GAITRite.
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
- •MS patients aged over 18 years
- •with gait problems related to spasticity of the triceps surae,
- •walking 10 m in less than a minute,
- •with or without technical assistance,
- •with an EDSS of 6.5 or less
- •triceps surae spasticity of between 1 and 3 on the Modified Ashworth Scale.
排除标准
- •Comprehension problems preventing the patient from expressing his/her free and informed consent to the study.
- •Intolerance to botulinum toxin;
- •botulinum toxin injection in the previous three months.
结局指标
主要结局
Spatiotemporal gait parameters
时间窗: At three months
Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: support distribution (in %).
次要结局
- Six-Minute Walk Test (6MWT)(at inclusion, at 6 weeks, at three months)
- the Multiple Sclerosis Walking Scale (MSWS-12)(at inclusion, at 6 weeks, at three months)
- the Goal Attainment Scale (GAS) score with determination(at inclusion, at 6 weeks, at three months)
- The Timed Up and Go test (TUG)(at inclusion, at 6 weeks, at three months)