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临床试验/NCT04036981
NCT04036981已完成不适用

The Effect of Muscle Selection for Botulinum Toxin A Injection on the Treatment Outcome in Poststroke Elbow Flexor Spasticity

Izmir Katip Celebi University1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2019年5月10日最近更新:
适应症
干预措施
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
55
试验地点
1
主要终点
Dynamic Component of Spasticity (Spasticity Angle)

研究概览

简要总结

Botulinum toxin A (BoNT A) has been reported to be effective in the treatment of elbow flexor spasticity. Although BoNT A is an efficacious treatment option, there is a debate in the selection of target muscle(s) for BoNT injection in the treatment of poststroke elbow flexor spasticity. The decision of muscle selection for BoNT A injection is mostly made according to the physical examination findings in real life practice.One of the guiding findings in this decision is the position of the spastic arm.

In this study, hypothesis is that the change in severity of spasticity with BoNT A injection differs depending on the muscle selection in chronic stroke patients with elbow flexor and forearm pronator spasticity.

详细描述

Botulinum neurotoxin A (BoNT A) has been reported to be effective in the treatment of elbow flexor spasticity. In the treatment of poststroke elbow flexor spasticity with BoNT A, three main muscles injected individually or in combination are musculus biceps brachii, musculus brachialis and musculus brachioradialis. Although BoNT is an efficacious treatment option, there is a debate in the selection of target muscle(s) for BoNT A injection in the treatment of poststroke elbow flexor spasticity. Superficiality of the biceps brachii muscle makes it an easy target for botulinum toxin injection. In dynamic electromyography studies, it has been reported that brachioradialis muscle is the most common contributor one to elbow flexion spasticity, followed by biceps brachii muscle. In the diagnostic selective nerve blocks, the brachialis muscle has been reported to be foreground. In a recent study using the modified Delphi Method Design, the expert committee was only fully agree on the application of BoNT A into the brachioradialis muscle.

The decision of muscle selection for BoNT A injection is mostly made according to the physical examination findings in real life practice. One of the guiding findings in this decision is the position of the spastic arm. The typical pattern of spastic elbow and forearm in patients with stroke is characterized by flexion at the elbow, and pronation in the forearm. As far as the investigators know, there has not been carried out any study investigating the effect of muscle selection for BoNT application on the treatment outcome (severity of spasticity) in chronic stroke patients with elbow flexor and forearm pronator spasticity.

The aim of this study is to investigate whether treatment response (change in severity of spasticity) differs according to BoNT A injected muscle in chronic stroke patients with elbow flexor and forearm pronator spasticity.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic (equal to or upper than 1 year) stroke patients with position of elbow flexion and forearm pronation while standing or sitting
  • Grade 2 or 3 elbow flexor spasticity and grade 1 to 3 forearm pronator spasticity according to Modified Ashworth Scale
  • Stage 2 or 3 Brunnstrom's motor recovery stage of upper extremity
  • To agree to participate in the study

排除标准

  • <18 years old
  • Pregnancy
  • Botulinum toxin injection within the last three months
  • Presence of elbow contracture
  • History of operation to spastic upper extremity
  • Spasticity due to other causes other than stroke
  • Do not agree to participate in the study

研究组 & 干预措施

Brachialis

Targeted muscle for BoNT A injection

干预措施: Botulinum toxin type A (Drug)

Biceps

Targeted muscle for BoNT A injection

干预措施: Botulinum toxin type A (Drug)

Brachialis plus Brachioradialis

Targeted muscles for BoNT A injection

干预措施: Botulinum toxin type A (Drug)

结局指标

主要结局

Dynamic Component of Spasticity (Spasticity Angle)

时间窗: up to 4 week

According to the Modified Tardieu Scale, the difference between the angle of slow passive motion and the angle of muscle reaction represents the dynamic component of spasticity (spasticity angle) in degree. A big difference suggests spasticity while the low difference suggests muscular contracture. In this study, dynamic component of spasticity (spasticity angle) of elbow joint at forearm pronation position will be evaluated.

次要结局

未报告次要终点

研究者

发起方
Izmir Katip Celebi University
申办方类型
Other
责任方
Principal Investigator
主要研究者

ilker şengül

Principal Investigator

Izmir Katip Celebi University

研究点 (1)

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