Effect of 3 Consecutives Botulinum Toxin Injection on Gait Pattern in Stroke Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- kinematics gait parameters
研究概览
简要总结
Chronic stroke patients exhibit gait pattern alterations which are mainly due to spasticity and treated with repetitive multifocal botulinum toxin injection(BTI). Several studies demonstrated that single BTI-session in a single muscle of paretic lower limb(LL) improved kinematic gait parameters(GP) but surprisingly none of them assessed the effects of repetitive multifocal BTI on patient's gait pattern and their duration.
The aim was to evaluate the impact of repetitive multifocal BTI-sessions on GP of chronic stroke patients. To that end, gait of patients will be compared using 3D-gait analysis after 3 consecutives BTI sessions.
详细描述
All the patients will be treated with BTI . These injections will be performed under electrical stimulation control (~5mA). The dose, the number of site of injection per muscle is at the discretion of the physician according to patients' needs and physicians' routine clinical practice. The dilution the most commonly used will be 100 U for 2.5ml (XEOMIN®)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years
- •a single hemispheric cerebral vascular lesion more than 6 months previously
- •able to walk 10 meters without any assistance
- •having benefited of at least 2 consecutive BTI sessions, second 3D gait analysis performed at least 3 months after the last BTI.
排除标准
- •patient's refusal to participate to the study
- •Inability to read the selected text
- •Inability to cooperate
- •No affiliation to social security
结局指标
主要结局
kinematics gait parameters
时间窗: 3h
peak knee flexion in swing phase(°)
次要结局
- spatiotemporal gait parameters(3h)
研究者
Nicolas ROCHE
MD PhD
Centre d'Investigation Clinique et Technologique 805