NCT00199589已完成不适用
Treatment of Spastic Equinovarus Foot After Stroke. Efficacy: Association Between Ankle Foot Orthosis and Botulinum Toxin A (BTA) Injection
University Hospital, Limoges2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2002年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Plantar contact during walking
研究概览
简要总结
This study evaluates treatment for spastic foot after stroke using ankle foot orthosis with or without selective injection of BTA (Botox).
详细描述
This prospective, multicentric open trial evaluates the efficacy of a combined treatment for spastic foot after stroke using ankle foot orthosis with or without selective injection of BTA (Botox) into the tibialis anterior and/or posterior and/or the long toe flexor, and/or medial and lateral gastrocnemius, and/or soleus muscles [300 BTA U per injection (Botox - Allergan), diluted with saline to a concentration of 5U/0,1 mL, with electromyography guided injection]. The patients are followed for one year after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Stroke patient with equinovarus foot due to severe lower limb extensor spasticity with impaired foot contact during walking
- •Ability to walk for at least 10 meters with or without aid
- •Stroke interval < 12 months
- •Age > 18 years old
- •Weight > 30 kg and < 100 kg
- •Written informed consent
排除标准
- •Stroke interval > 12 months
- •Age < 18 years old
- •Pregnancy
- •Neuromuscular disease
- •Previous treatment with BTA
- •Fixed contractures impairing mobility
- •Mini-Mental Status Examination < 25
- •Aminosides treatment.
结局指标
主要结局
Plantar contact during walking
次要结局
- Gait velocity
- Barthel index
- MIF
- Autosatisfaction by EVA
- Asworth scale
- Ankle range of motion
研究者
研究点 (2)
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