Comparison of the Efficacy of 2 Different Botulinum Toxin Injection Techniques in Gastrocnemius Muscle Spasticity in Hemiplegic Patients: A Randomized Double-blind Controlled Study.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- ambulation level (change between pre-injection and 1-month control)
研究概览
简要总结
The aim of the study is to compare the effectiveness of the classical (2-4 points to the muscle proximal) application of botulinum toxin in the treatment of spasticity with the application along the length of the gastrecnemius muscle.
The main question it aims to answer Is botulinum toxin more effective in the treatment of spasticity than the classical application applied along the length of the gastrocnemius muscle? Participants will be evaluated for spasticity before and 1 month after injection.
Researchers will compare classical versus application along the length of the muscle to see if there is a reduction in 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with spastic hemiplegia
- •Spasticity in the gastrocnemius muscle
排除标准
- •Those who have spasticity in other muscles that will affect ankle movements
- •Those who use myorelaxant or myospasm-effective drugs
- •Those who have been applied botulinum toxin in the last 3 months
- •Those who have contractures in the ankle and knee due to orthopedic reasons.
研究组 & 干预措施
Classic injection
200iu/2ml OnabotulinumtoxinA in total to 2-4 points proximal to the gastrocnemius muscle
干预措施: Onabotulinumtoxina for Injection (Drug)
İnjection along the length of the muscle
A total of 200iu/2ml of onabotulinumtoxinA by spreading along the length of the gastrocnemius muscle
干预措施: Onabotulinumtoxina for Injection (Drug)
结局指标
主要结局
ambulation level (change between pre-injection and 1-month control)
时间窗: before injection and 1 month after injection
functional ambulation scale
Spasticity assessment (change between pre-injection and 1-month control)
时间窗: before injection and 1 month after injection
Joint range of motion measurement
ambulation velocity (change between pre-injection and 1-month control)
时间窗: before injection and 1 month after injection
preferred walking speed
次要结局
未报告次要终点
研究者
Savaş Karpuz
Medical doctor
Konya Beyhekim Training and Research Hospital