Assesment of Post-stroke Elbow Flexor Spasticity in Different Forearm Positions

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ClinicalTrials.gov Identifier: NCT03563209

Recruitment Status : Completed

First Posted : June 20, 2018

Results First Posted : May 10, 2019

Last Update Posted : May 22, 2019

Sponsor:

Information provided by (Responsible Party):

ilker şengül, Izmir Katip Celebi University

Study Description

Brief Summary:

Determination of which muscle is more spastic before injection of the botulinum toxin, and the application of the targeted treatment to that muscle results in more improvement in spasticity. It is known that the muscles that flex elbow in healthy individuals change according to forearm position. While the biceps brachii flexes the forearm in supination, the brachioradialis flexes the forearm in the neutral position. The brachialis muscle acts as a primary flexor muscle when the forearm is in pronation.

In this study, hypothesis is that the severity of spasticity differs depending on the forearm position.

Condition or disease
Post-stroke Elbow Spasticity

Detailed Description:

There are three main muscles that contribute to elbow flexor spasticity; musculus biceps brachii, musculus brachialis and musculus brachioradialis. Muscle selection in elbow flexor spasticity for botulinum toxin application has impact on treatment outcome. The 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.

Determination of which muscle is more spastic before injection of the botulinum toxin, and the application of the targeted treatment to that muscle results in more improvement in spasticity. Can the target muscle selection clinically be performed instead of methods such as electromyography where equipment is required and the evaluation period is relatively long? Can semi-quantitative methods used to assess the severity of spasticity provide reliable information regarding the muscle or muscles that contribute to elbow flexor spasticity? It is known that the muscles that flex elbow in healthy individuals change according to forearm position. While the biceps brachii flexes the forearm in supination, the brachioradialis flexes the forearm in the neutral position. The brachialis muscle acts as a primary flexor muscle when the forearm is in pronation.

The aim of this study is to investigate whether the severity of spasticity differs depending on the forearm position.

Study Design

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Study Type :	Observational
Actual Enrollment :	60 participants
Observational Model:	Case-Only
Time Perspective:	Cross-Sectional
Official Title:	Assesment of Post-stroke Elbow Flexor Spasticity in Response to Passive Stretch in Different Forearm Positions
Actual Study Start Date :	March 15, 2018
Actual Primary Completion Date :	August 15, 2018
Actual Study Completion Date :	August 15, 2018

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

Dynamic Component of Spasticity (Spasticity Angle) [ Time Frame: 1 day (Only one measurement was performed in time (cross-sectional)) ]
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) at forearm pronation, neutral position and supination was evaluated separately.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with post-stroke elbow flexor spasticity

Criteria

Inclusion Criteria:

Elbow flexor spasticity
Grade 1 to 3 spasticity measured with Modified Ashworth Scale
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

Contacts and Locations

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): NCT03563209

Locations

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Turkey
Ilker Şengül
İzmir, In The USA Or Canada, Please Select..., Turkey, 35360

Sponsors and Collaborators

Izmir Katip Celebi University

Investigators

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Principal Investigator:	ilker şengül	İzmir Katip Çelebi University

Study Documents (Full-Text)

Documents provided by ilker şengül, Izmir Katip Celebi University:

Study Protocol and Statistical Analysis Plan [PDF] February 21, 2018

More Information

Publications:

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

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.

Keenan MA, Haider TT, Stone LR. Dynamic electromyography to assess elbow spasticity. J Hand Surg Am. 1990 Jul;15(4):607-14.

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.

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

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.

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Responsible Party:	ilker şengül, Principal Investigator, Izmir Katip Celebi University
ClinicalTrials.gov Identifier:	NCT03563209
Other Study ID Numbers:	21.02.2018-84
First Posted:	June 20, 2018 Key Record Dates
Results First Posted:	May 10, 2019
Last Update Posted:	May 22, 2019
Last Verified:	May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by ilker şengül, Izmir Katip Celebi University:


Elbow spasticity Stroke

Additional relevant MeSH terms:

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Muscle Spasticity Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases	Cardiovascular Diseases Muscular Diseases Musculoskeletal Diseases Muscle Hypertonia Neuromuscular Manifestations Neurologic Manifestations

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