EUCTR2018-002499-42-BE进行中（未招募）1 期
Evaluation of the effect of repeated injections of high doses of botulinum toxin into the lower limb of spastic brain lesions on functional and biomechanical parameters of walking
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 330
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. adults (> 18 years)
- •2.hemiparesis after first stroke, delay after stroke> 6 months
- •3. limb-gait spasticity
- •4.ability to perform treadmill walking tests, indication of focal chemical denervation
- •Sub-study :
- •1. old: > 4 and <18 years,
- •2.cerebral palsy (spastic hemiplegia, diplegia or quadriplegia)
- •3. Gross Motor Function Classification System (GMFCS) <4.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 120
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •1. aphasia or major cognitive impairment limiting functional evaluation
- •2. neurological or orthopedic problem interfering with the function of the lower limb studied
- •3. injections of botulinum toxin in the lower limb less than 5 months old
- •4.contraindication to botulinum toxin (neuromuscular disease under -cente)
- •5.contraindication to performing an MRI.
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