Optimal Dose of Extracorporeal Shock Wave Therapy After Botulinum Toxin Type A Injection for Post-stroke Spasticity
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Range of Motion (ROM) of elbow flexor
研究概览
简要总结
Recently, It is known that the efficacy of botulinum toxin type A (BTX-A) with extracorporeal shock wave therapy (ESWT) is greater than that of BTX-A with electrical stimulation in the management of post-stroke spasticity of the upper limb. However, it was not determined which dose of ESWT is optimal as a adjuvant therapy after BTX-A injection on the upper limb in patients with stroke. Therefore, the aim of this study is to evaluate the optimal dose of ESWT after botulinum toxin type A injection for post-stroke 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
- Double (Participant, 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
- •Age ≥20 years
- •inpatients
- •Elbow flexor spasticity in patients, confirmed to be mainly due to biceps brachii
- •Modified Ashworth scale (MAS) ≥2,
- •At least a 3-month period from stroke,
- •Written informed consent has been obtained
排除标准
- •Fixed contractures and/or deformities at the elbow,
- •Previous fractures of the paretic upper limb,
- •Peripheral nervous system disorders/myopathies,
- •Previous BTX-A treatment and/or ESWT,
- •Structural alterations in the soft tissue (e.g., fibrosis),
- •Known allergy or sensitivity to the study medication or its components
- •Presence of an unstable medical condition or uncontrolled systemic disease
- •Any medical condition that may put the patient at increased risk with exposure to botulinum toxin therapy. (ex. Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interface with neuromuscular function.
- •Bleeding tendency and/or anticoagulation therapy
- •Presence of infection or skin disorder at injection sites
- •Females were are pregnant, nursing, or are planning a pregnancy during the study
- •Females of child-bearing potential (including pre-menstrual woman), not using a reliable means of contraception
- •Participant who should be withdrawn from the study in the opinion of the investigator for any reason
研究组 & 干预措施
60mJ ESWT
ESWT (0.04 mJ/mm2, 1500 shock + sham stimulation 2500) / total dose per treatment : 60mJ
干预措施: Extracorporeal shock wave therapy 60mj (Procedure)
120mJ ESWT
ESWT (0.04 mJ/mm2, 4000 shock) / total dose per treatment : 160mJ
干预措施: Extracorporeal shock wave therapy 120mj (Procedure)
sham ESWT stimulation
ESWT (0 mJ/mm2, sham stimulation 4000) / total dose per treatment : 0mJ
干预措施: non extracorporeal shock wave therapy (Procedure)
结局指标
主要结局
Range of Motion (ROM) of elbow flexor
时间窗: 5 weeks
次要结局
未报告次要终点