NCT02757404已完成4 期
Impact of Injection Techniques on the Effectiveness of Botulinum Toxin for the Treatment of Post Stroke Upper Limb Spasticity
Medy-Tox0 个研究点目标入组 59 人开始时间: 2016年5月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 主要终点
- Comparison evaluation on improvement rate of spasticity assessed by Modified Ashworth Scale between 3 arms.
研究概览
简要总结
Botulinum Toxin for the Treatment of Post Stroke Upper Limb Spasticity.
详细描述
This study is "A Multicenter, Prospective, Randomized, Evaluator Blinded, Comparing Phase 4 Study to Evaluate the Impact of Injection Techniques on the Effectiveness of Botulinum Toxin for the Treatment of Post Stroke Upper Limb Spasticity".
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subject aged over
- •Subjects who has grade 1 + and more spasticity at least one of upper limb muscles as measured on Modified Ashworth Scale after stroke.
- •Subjects who was diagnosed stroke at least 1 month prior to study participation.
- •Subjects or legal representatives who voluntarily decided the participation of the study and signed the informed consent.
排除标准
- •Subjects who had spinal injuries to be a factor of spasticity except for stroke prior to study enrollment.
- •Subjects with allergy or hypersensitivity to the Botulinum Toxin.
- •Subjects who have changed the muscle relaxant taking for treatment within past 4 weeks prior to study participation.
- •Subjects who have taken injection treatments using alcohol or phenol in upper limb within past 6 months prior to study participation.
- •Subjects with general neuromuscular synaptic disorder(e.g. Myasthenia gravis, Lambert-Eaton syndrome, Amyotrophic lateral sclerosis).
- •Subjects who have been injected with botulinum toxin within past 3 months before the injection.
- •Subjects who are pregnant or lactating of disagreed to avoid pregnancy during 3 months study period.
- •Subjects who are scheduled to take part in other clinical trial during the study period.
- •Patients who are not eligible for this study at the medical discretion of the investigator.
研究组 & 干预措施
Ultrasonography guidance
Experimental
Ultrasonography guidance injection of Meditoxin®.
干预措施: Ultrasonography guidance injection of Meditoxin®. (Drug)
Electrical stimulation guidance
Experimental
Electrical stimulation guidance injection of Meditoxin®.
干预措施: Electrical stimulation guidance injection of Meditoxin®. (Drug)
Manual needle placement
Experimental
Manual needle placement injection of Meditoxin®.
干预措施: Manual needle placement injection of Meditoxin®. (Drug)
结局指标
主要结局
Comparison evaluation on improvement rate of spasticity assessed by Modified Ashworth Scale between 3 arms.
时间窗: 4 weeks
次要结局
- Comparison evaluation on improvement rate of spasticity assessed by Modified Tardieu Scale between 3 arms.(4 weeks)
- Comparison evaluation on improvement rate of range of motion on each joint between 3 arms.(4 weeks)
研究者
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