Clinical trial NCT03563209: Assesment of Post-stroke Elbow Flexor Spasticity in Different Forearm Positions
Official title: Assesment of Post-stroke Elbow Flexor Spasticity in Response to Passive Stretch in Different Forearm Positions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-stroke Elbow Spasticity
Keywords: Elbow spasticity
Stroke
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2018-06-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with post-stroke elbow flexor spasticity

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.

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.

Eligibility 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

Primary outcomes:
measure: Dynamic Component of Spasticity (Spasticity Angle)
timeFrame: 1 day (Only one measurement was performed in time (cross-sectional))
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ilker Şengül
state: In The USA Or Canada, Please Select...
Study officials:
affiliation: İzmir Katip Çelebi University
name: ilker şengül
role: PRINCIPAL_INVESTIGATOR
References:
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