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

NCT ID: NCT03563209

Last Updated: 2019-05-22

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-15

Study Completion Date

2018-08-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Post-stroke Elbow Spasticity

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Izmir Katip Celebi University

OTHER

Sponsor Role lead

Responsible Party

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ilker şengül

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ilker şengül

Role: PRINCIPAL_INVESTIGATOR

İzmir Katip Çelebi University

Locations

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Ilker Şengül

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

Site Status

Countries

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Turkey (Türkiye)

References

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

Reference Type BACKGROUND
PMID: 3042230 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27595994 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2380525 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 13475410 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3809245 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20927007 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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21.02.2018-84

Identifier Type: -

Identifier Source: org_study_id

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