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

NCT04036981 | Completed FDA Drug

• 1 other identifier: 2018-KAE-0230
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Spasticity

Keywords

Stroke; Muscle spasticity; Botulinum toxin A

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Brachialis

Targeted muscle for BoNT A injection

Drug: Botulinum toxin type A

Biceps

Targeted muscle for BoNT A injection

Drug: Botulinum toxin type A

Brachialis plus Brachioradialis

Targeted muscles for BoNT A injection

Drug: Botulinum toxin type A

Interventions

Botulinum toxin type A DRUG

Injection of botulinum toxin A into the spastic elbow flexor muscle or muscles

Also known as: Botox, Dysport

Biceps; Brachialis; Brachialis plus Brachioradialis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stroke patients with elbow flexor and forearm pronator spasticity

You may qualify if:

• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

İlker Şengül

Izmir, In the USA Or Canada, Please Select..., 35360, Turkey (Türkiye)

Location

Related Publications (9)

• Keenan MA. Management of the spastic upper extremity in the neurologically impaired adult. Clin Orthop Relat Res. 1988 Aug;(233):116-25.

  PMID: 3042230 BACKGROUND

• Genet F, Schnitzler A, Droz-Bartholet F, Salga M, Tatu L, Debaud C, Denormandie P, Parratte B. Successive motor nerve blocks to identify the muscles causing a spasticity pattern: example of the arm flexion pattern. J Anat. 2017 Jan;230(1):106-116. doi: 10.1111/joa.12538. Epub 2016 Sep 6.

  PMID: 27595994 BACKGROUND

• Keenan MA, Haider TT, Stone LR. Dynamic electromyography to assess elbow spasticity. J Hand Surg Am. 1990 Jul;15(4):607-14. doi: 10.1016/s0363-5023(09)90023-5.

  PMID: 2380525 BACKGROUND

• BASMAJIAN JV, LATIF A. Integrated actions and functions of the chief flexors of the elbow: a detailed electromyographic analysis. J Bone Joint Surg Am. 1957 Oct;39-A(5):1106-18. No abstract available.

  PMID: 13475410 BACKGROUND

• Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.

  PMID: 3809245 BACKGROUND

• Gracies JM, Bayle N, Vinti M, Alkandari S, Vu P, Loche CM, Colas C. Five-step clinical assessment in spastic paresis. Eur J Phys Rehabil Med. 2010 Sep;46(3):411-21.

  PMID: 20927007 BACKGROUND

• Hefter H, Jost WH, Reissig A, Zakine B, Bakheit AM, Wissel J. Classification of posture in poststroke upper limb spasticity: a potential decision tool for botulinum toxin A treatment? Int J Rehabil Res. 2012 Sep;35(3):227-33. doi: 10.1097/MRR.0b013e328353e3d4.

  PMID: 22555318 BACKGROUND

• Simpson DM, Patel AT, Alfaro A, Ayyoub Z, Charles D, Dashtipour K, Esquenazi A, Graham GD, McGuire JR, Odderson I. OnabotulinumtoxinA Injection for Poststroke Upper-Limb Spasticity: Guidance for Early Injectors From a Delphi Panel Process. PM R. 2017 Feb;9(2):136-148. doi: 10.1016/j.pmrj.2016.06.016. Epub 2016 Jun 23.

  PMID: 27346090 BACKGROUND

• Sengul I, Askin A, Tosun A. Effect of muscle selection for botulinum neurotoxin treatment on spasticity in patients with post-stroke elbow flexor muscle over-activity: an observational prospective study. Somatosens Mot Res. 2022 Mar;39(1):10-17. doi: 10.1080/08990220.2021.1986383. Epub 2021 Oct 10.

  PMID: 34632927 DERIVED

MeSH Terms

Conditions

Muscle Spasticity; Stroke

Interventions

Botulinum Toxins, Type A; abobotulinumtoxinA

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• İlker Şengül, M.D.

  Izmir Katip Celebi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: July 30, 2019
• Study Start: May 10, 2019
• Primary Completion: May 3, 2021
• Study Completion: June 1, 2021
• Last Updated: June 23, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)