Effects of Chemodenervation (Botulinum Toxin A) and Serial Casting vs Botulinum Toxin A and Without Serial Casting in Lower Limb Spasticity Following ABI
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Passive ankle dorsiflexion >10 degrees
研究概览
简要总结
Effects of Chemodenervation (Botulinum Toxin A) and Serial Casting vs Botulinum Toxin A and without serial casting in Lower Limb Spasticity following ABI.
详细描述
The investigators will be studying the effects of Chemodenervation (Botulinum Toxin A) and Serial Casting vs Botulinum Toxin A and without serial casting in Lower Limb Spasticity following ABI.
patients are randomly divided into two groups: group 1 will undergo botox injection with weekly serial casting group 2 will undergo botox injection with physiotherapy The primary outcome is the effects of the proposed treatment with respect to passive dorsiflexion.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Chemodenervation + Serial Casting
in this group a total of 10 patients will undergo Botulinum Toxin A injection and weekly serial casting Intervention = Weekly Serial Casting AND Botulinum Toxin A injection (350-400 units per treated limb)
干预措施: Botulinum toxin type A (Drug)
Chemodenervation + Serial Casting
in this group a total of 10 patients will undergo Botulinum Toxin A injection and weekly serial casting Intervention = Weekly Serial Casting AND Botulinum Toxin A injection (350-400 units per treated limb)
干预措施: Serial Casting (Device)
Chemodenervation without serial casting
in this group a total of 10 patients will undergo Botulinum Toxin A injection. Intervention = Botulinum Toxin A injection (350-400 units per treated limb) alone.
干预措施: Botulinum toxin type A (Drug)
结局指标
主要结局
Passive ankle dorsiflexion >10 degrees
时间窗: 4-6 weeks
we are measuring passive ankle range of motion with respect to dorsiflexion greater than 10 degrees
次要结局
未报告次要终点
研究者
Ali Fateh
Resident - Dept of Physical Medicine and Rehabilitation
Hamilton Health Sciences Corporation