ClinicalTrials.Veeva

Menu

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

I

Izmir Katip Celebi University

Status

Completed

Conditions

Muscle Spasticity

Treatments

Drug: Botulinum toxin type A

Study type

Observational

Funder types

Other

Identifiers

NCT04036981
2018-KAE-0230

Details and patient eligibility

About

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.

Full description

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.

Enrollment

55 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

55 participants in 3 patient groups

Brachialis
Description:
Targeted muscle for BoNT A injection
Treatment:
Drug: Botulinum toxin type A
Biceps
Description:
Targeted muscle for BoNT A injection
Treatment:
Drug: Botulinum toxin type A
Brachialis plus Brachioradialis
Description:
Targeted muscles for BoNT A injection
Treatment:
Drug: Botulinum toxin type A

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems