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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04036981
Recruitment Status : Recruiting
First Posted : July 30, 2019
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
ilker şengül, Izmir Katip Celebi University

Brief Summary:

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.


Condition or disease Intervention/treatment
Muscle Spasticity Drug: Botulinum toxin type A

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Effect of Muscle Selection for Botulinum Toxin A Injection on the Treatment Outcome in Poststroke Elbow Flexor Spasticity
Actual Study Start Date : May 10, 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Group/Cohort Intervention/treatment
Brachialis
Targeted muscle for BoNT A injection
Drug: Botulinum toxin type A
Injection of botulinum toxin A into the spastic elbow flexor muscle or muscles
Other Names:
  • Botox
  • Dysport

Biceps
Targeted muscle for BoNT A injection
Drug: Botulinum toxin type A
Injection of botulinum toxin A into the spastic elbow flexor muscle or muscles
Other Names:
  • Botox
  • Dysport

Brachioradialis
Targeted muscle for BoNT A injection
Drug: Botulinum toxin type A
Injection of botulinum toxin A into the spastic elbow flexor muscle or muscles
Other Names:
  • Botox
  • Dysport

Combinations
Targeted muscles for BoNT A injection
Drug: Botulinum toxin type A
Injection of botulinum toxin A into the spastic elbow flexor muscle or muscles
Other Names:
  • Botox
  • Dysport




Primary Outcome Measures :
  1. Dynamic Component of Spasticity (Spasticity Angle) [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Stroke patients with elbow flexor and forearm pronator spasticity
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04036981


Contacts
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Contact: İlker Şengül, M.D. +905337333698 ilkrsngl@gmail.com
Contact: Ayhan Aşkın, M.D. +905327621932 ayhanaskın@hotmail.com

Locations
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Turkey
İlker Şengül Recruiting
İzmir, In The USA Or Canada, Please Select..., Turkey, 35360
Contact: İlker Şengül, M.D.    05337333698    ilkrsngl@gmail.com   
Contact: Ayhan Aşkın, M.D.    05327621932    ayhanaskin@hotmail.com   
Principal Investigator: İlker Şengül, M.D.         
Sub-Investigator: Ayhan Aşkın, M.D.         
Sub-Investigator: Aliye Tosun, M.D.         
Sponsors and Collaborators
Izmir Katip Celebi University
Investigators
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Principal Investigator: İlker Şengül, M.D. Izmir Katip Celebi University
Publications:

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Responsible Party: ilker şengül, Principal Investigator, Izmir Katip Celebi University
ClinicalTrials.gov Identifier: NCT04036981    
Other Study ID Numbers: 2018-KAE-0230
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by ilker şengül, Izmir Katip Celebi University:
Stroke
Muscle spasticity
Botulinum toxin A
Additional relevant MeSH terms:
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Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents