Muscle Selection for Botulinum Toxin A Injection in Poststroke Elbow Flexor Spasticity

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Muscle Spasticity

Intervention / Treatment
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* Drug: Botulinum toxin type A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: <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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Brachialis<br>Targeted muscle for BoNT A injection | Drug: Botulinum toxin type A<br>* Injection of botulinum toxin A into the spastic elbow flexor muscle or muscles<br>* Other names: Dysport;|
| Biceps<br>Targeted muscle for BoNT A injection | Drug: Botulinum toxin type A<br>* Injection of botulinum toxin A into the spastic elbow flexor muscle or muscles<br>* Other names: Dysport;|
| Brachialis plus Brachioradialis<br>Targeted muscles for BoNT A injection | Drug: Botulinum toxin type A<br>* Injection of botulinum toxin A into the spastic elbow flexor muscle or muscles<br>* Other names: Dysport;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamic Component of Spasticity (Spasticity Angle) | 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. | up to 4 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Muscle spasticity, Botulinum toxin A